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RecruitingInterventionalPhase 2

A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph-Negative, CD22-Positive B-Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults With Relapsed or Refractory Disease

NCT ID: NCT03739814Sponsor: National Cancer Institute (NCI)Last updated: 2026-06-03

Summary

This phase II trial studies how well inotuzumab ozogamicin and blinatumomab with or without ponatinib work in treating patients with CD22-positive B-lineage acute lymphoblastic leukemia that is newly diagnosed, has come back after a period of improvement (recurrent), or does not respond to treatment (refractory). Inotuzumab ozogamicin is a monoclonal antibody, called inotuzumab, linked to a chemotherapy drug, called ozogamicin. Inotuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD22 receptors, and delivers ozogamicin to kill them. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Ponatinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving inotuzumab ozogamicin and blinatumomab with or without ponatinib may be effective in treating patients with newly diagnosed, recurrent or refractory CD22 positive B-lineage acute lymphoblastic leukemia.

Detailed description

PRIMARY OBJECTIVES: Ia. For Philadelphia (Ph)-negative B-cell acute lymphoblastic leukemia (ALL), to confirm tolerability of the combination regimen of inotuzumab ozogamicin followed by blinatumomab. Ib. For Ph-positive B-cell ALL, to confirm tolerability of ponatinib in combination with inotuzumab ozogamicin and blinatumomab. II. To estimate the 1-year event-free survival of older, transplant-ineligible patients with newly diagnosed, Ph-negative, CD22-positive, B-cell acute lymphoblastic leukemia (ALL) treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 1) III. To estimate the 1-year event-free survival of patients with relapsed or refractory Ph-negative, CD22-positive, B-cell ALL treated with inotuzumab ozogamicin induction followed by blinatumomab consolidation. (Cohort 2) IV. To determine the feasibility of the regimen in adult patients with CD22-positive, Ph/BCR-ABL1-positive B-cell ALL. (Cohort 3) SECONDARY OBJECTIVES: I. To estimate the median, 1-year, and 3-year overall survival (OS) in all eligible patients. (Cohort 1) II. To estimate the median, 1-year, and 3-year relapse-free survival (RFS) in all eligible patients. (Cohort 1) III. To estimate the median and 3-year event-free survival (EFS) in all eligible patients. (Cohort 1) IV. To estimate the complete response (CR) rate and overall response rate (ORR, defined as complete response \[CR\] + complete response with incomplete count recovery \[CRi\]) to inotuzumab ozogamicin followed by blinatumomab (regimen CR rate and ORR). (Cohort 1) V. To estimate the CR rate and ORR (CR + CRi) to inotuzumab ozogamicin induction alone (induction CR and ORR). (Cohort 1) VI. To estimate the minimal residual disease (MRD) negativity rate in subjects achieving a CR or CRi. (Cohort 1) VII. To estimate the treatment-related mortality with this regimen. (Cohort 1) VIII. To describe the safety and tolerability of this regimen. (Cohort 1) IX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 2) X. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 2) XI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 2) XII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery \[CRh\]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 2) XIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 2) XIV. To determine the MRD negativity (\< 10\^-4) rate at defined time points including prior to allogeneic HCT and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 2) XV. To determine the allogeneic hematopoietic cell transplantation (HCT) rate in eligible subjects. (Cohort 2) XVI. To estimate the treatment-related mortality with this regimen. (Cohort 2) XVII. To describe the safety and tolerability of this regimen. (Cohort 2) XVIII. To estimate the 24-week complete molecular response rate. (Cohort 3) XIX. To estimate the median, 1-year, and 3-year OS in all eligible patients. (Cohort 3) XX. To estimate the median, 1-year, and 3-year RFS in all eligible patients. (Cohort 3) XXI. To estimate the median and 3-year EFS in all eligible patients. (Cohort 3) XXII. To estimate ORR (CR/CRi and CR/complete response with partial hematologic recovery \[CRh\]) to blinatumomab in patients with ALL refractory to inotuzumab ozogamicin. (Cohort 3) XXIII. To estimate the CR, CRi, and CRh rates at defined time points and cumulatively for the entire regimen. (Cohort 3) XXIV. To determine the complete molecular response rate at defined time points and cumulatively in patients achieving a CR, CRh, or CRi. (Cohort 3) XXV. To estimate the treatment-related mortality with this regimen. (Cohort 3) XXVI. To describe the safety and tolerability of this regimen. (Cohort 3) OTHER OBJECTIVE: I. Results of the primary analysis will be examined for consistency, while accounting for the stratification factors and/or covariates of baseline quality of life (QOL) and fatigue. CORRELATIVE SCIENCE OBJECTIVES: I. To correlate specific karyotype groups (normal or various primary and secondary chromosomal abnormalities) with clinical and laboratory parameters. II. To correlate specific karyotype groups with response rates, response duration, survival, and cure in patients treated with inotuzumab ozogamicin followed by blinatumomab. III. To correlate specific karyotype groups with MRD. IV. To determine karyotype changes at relapse and the influence of the type of change (or no change) in karyotype at relapse. V. To assess the correlation of quantitative MRD post-induction with inotuzumab ozogamicin and at sequential consolidation time points with blinatumomab with RFS, EFS, and OS. VI. To correlate the influence of MRD status (detectable versus \[vs.\] not and as a continuous measure) in relation to EFS, RFS, and OS with other clinical and biological factors (e.g. previously untreated vs. relapsed disease cohorts; age, initial white blood cell \[WBC\] count, cytogenetics). VII. To identify genetic variants and predictors of ex vivo resistance. VIII. To identify genetic variants and predictors of MRD. IX. To identify genetic variants and predictors of relapse. X. To determine inter-patient variability in drug sensitivity of adult ALL. XI. To examine the associations of drug sensitivity with host and leukemia molecular features. XII. To evaluate T-cell populations and T-cell function during therapy using T-cell markers which include the T-cell subset defining markers CD45, CD3, CD4, CD8, CD45RA, CD45RO, CCR7, CD25, CD127, FOXP3, CD 27, CD28, among others, and markers of T cell exhaustion and senescence including CD57, PD-1, Tim-3, LAG-3, TIGIT, CTLA4, CD160, and ICOS among others. XIII. To evaluate cytokine levels, and compare between patients who attain a CR vs. those with stable or progressive disease. EXPLORATORY OBJECTIVES: I. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 1) II. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi to inotuzumab ozogamicin. (Cohort 1) III. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving MRD-negative vs. MRD-positive CR/CRi at any time. (Cohort 1) IV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 1) V. To estimate the rate of cytokine release syndrome in this population. (Cohort 1) VI. To estimate the median, 1-year, and 3-year RFS from time of CR/CRi to inotuzumab ozogamicin in patients receiving inotuzumab ozogamicin followed by blinatumomab and not undergoing allogeneic hematopoietic cell transplantation (HCT). (Cohort 2) VII. To estimate median, 1-year, and 3-year OS after CR/CRi to inotuzumab ozogamicin in patients not undergoing allogeneic HCT. (Cohort 2) VIII. To compare in a non-randomized fashion median, 1-year, and 3-year OS, median, 1-year, and 3-year RFS, cumulative incidence of relapse (CIR), and non-relapse mortality (NRM) between patients achieving CR/CRi and receiving consolidation with or without allogeneic HCT. (Cohort 2) IX. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 2) X. To estimate the rate of cytokine release syndrome in this population. (Cohort 2) XI. To estimate the median, 1-year, and 3-year RFS, EFS, and OS in patients achieving a CR/CRi to inotuzumab ozogamicin. (Cohort 3) XII. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients with CR/CRi achieving complete molecular response vs. not to inotuzumab ozogamicin. (Cohort 3) XIII. To compare the median, 1-year, and 3-year RFS, EFS, and OS among patients achieving CR/CRi achieving complete molecular response vs. not at any time. (Cohort 3) XIV. To describe the rate, severity, and timing of sinusoidal obstruction syndrome/veno-occlusive disease (SOS/VOD) of the liver after limited inotuzumab ozogamicin exposure and identify risk factors for SOS/VOD. (Cohort 3) XV. To estimate the rate of cytokine release syndrome in this population. (Cohort 3) XVI. To assess ABL1 mutational patterns at relapse. (Cohort 3) OUTLINE: Patients are assigned to 1 of 2 cohorts. COHORT 1: Patients receive inotuzumab ozogamicin intravenously (IV) over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. By the end of Course II, patients with CR-CRi to Course IB/IC and Course II continue to Course IIIA, patients without adequate ALL cytoreduction to Course IA or refractory to Course IB/IC but CR/CRi to Course II continue to Course IIIB. Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study. COHORT 2: Patients receive inotuzumab ozogamicin IV over 1 hour on day 1, 8, and 15 (Course IA). By the end of Course IA (day 21), patients with adequate ALL cytoreduction continue to Course IB/IC, and patients who fail to achieve ALL cytoreduction continue to Course II. Patients with CR/CRi at the end of Course II continue to Course IIIB. COURSE IB/IC: Patients receive inotuzumab ozogamicin IV over 1 hour on days 1, 8, and 15. Treatment continues for 1 course (28 days) in the absence of disease progression or unacceptable toxicity. COURSE II: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. COURSE IIIA: Patients receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. COURSE IIIB: Patients receive blinatumomab IV continuously on days 1-28, 43-70, and 85-112. Treatment continues for 1 course (126 days) in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study. COHORT 3: INDUCTION: COURSE I: Patients receive ponatinib orally (PO) daily (QD) on day 1-35, dexamethasone PO QD on days 1-7 and 15-21 and methotrexate intrathecally (IT) on day 1, 15 and 29 for 1 course (35 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi continue to consolidation course IIA or end the study treatment to receive allogenic HCT per the treating physician. Patients without CR or CRi with but adequate ALL cytoreduction (defined as ≥ 50% reduction in bone marrow lymphoblasts from the pre-registration bone marrow aspirate/biopsy and/or ≤ 20% marrow cellularity at the end of Course I bone marrow aspirate/biopsy) also proceed to consolidation course IIA. Patients with progression or failure to achieve adequate ALL cytoreduction are removed from study treatment. CONSOLIDATION: COURSE IIA: Patients receive ponatinib PO QD on days 1-21, inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 and methotrexate IT on day 1 for 1 course (21 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi continue to consolidation course IIB or end the study treatment to receive allogenic HCT per the treating physician. Patients without CR or CRi and without progressive disease proceed to course IIC. Patients with progression are removed from study treatment. COURSE IIB/C: Patients receive ponatinib PO QD on days 1-28, inotuzumab ozogamicin IV over 1 hour on days 1, 8 and 15 and methotrexate IT on day 1 for 1 course (28 days) in the absence of disease progression or unacceptable toxicity. Patients with CR or CRi end the study treatment to receive allogenic HCT per the treating physician. Patients with progression are removed from study treatment. All other patients proceed to course III. COURSE III: Patients receive ponatinib PO QD on days 1-84 and receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. Patients in CR/CRi proceed to course IV. Patients not in CR/CRi are removed from study treatment. COURSE IV: Patients receive ponatinib PO QD on days 1-84 and receive blinatumomab IV continuously on days 1-28 and 43-70. Treatment continues for 1 course (84 days) in the absence of disease progression or unacceptable toxicity. Patients in CR/CRi proceed to maintenance. Patients not in CR/CRi are removed from study treatment. MAINTENANCE: Patients receive ponatinib PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Patients undergo bone marrow aspiration and biopsy and blood sample collection throughout the study. Patients undergo lumbar puncture with cerebrospinal fluid sample collection at baseline and may undergo additionally throughout the study. After completion of study treatment, patients are followed up every 3 months for 3 years, and then every 6 months for up to 10 years.

Arms & interventions

  • ProcedureBiospecimen Collection

    Undergo blood sample and cerebrospinal fluid collection

  • BiologicalBlinatumomab

    Given IV

  • ProcedureBone Marrow Aspiration

    Undergo bone marrow aspiration

  • ProcedureBone Marrow Biopsy

    Undergo bone marrow biopsy

  • BiologicalInotuzumab Ozogamicin

    Given IV

  • ProcedureLumbar Puncture

    Undergo lumbar puncture

  • DrugPonatinib

    Given PO

Outcome measures

Primary

  • Event-free survival

    Will be defined as time from start of treatment to failure to achieve complete response (CR)/complete response with incomplete count recovery (CRi) after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause

    Time frame: At 1 year

  • Completion of protocol treatment (cohort 3)

    Feasibility defined as completion of the planned therapy as defined in the protocol. Success rate defined as the proportion of patients who either complete entire protocol treatment or go off protocol treatment due to the disease (e.g., refractory disease, progression, and relapse).

    Time frame: Up to 10 years

Secondary

  • Overall survival (OS)

    Time frame: Time from start of study therapy to death from any cause censored at the last known alive date, assessed up to 10 years

  • Relapse-free survival (RFS)

    Time frame: Time from first CR/CRi to progressive disease (relapse, treatment discontinuation due to health deterioration) or death, assessed up to 10 years

  • Event-free survival (EFS)

    Time frame: Time from start of treatment to failure to achieve CR/CRi after completing Course II of blinatumomab, relapse after CR/CRi, progression on study requiring withdrawal from study therapy, or death from any cause, assessed up to 10 years

  • Complete and overall response rate

    Time frame: Up to 10 years

  • Minimal residual disease negativity

    Time frame: Up to 10 years

  • Complete molecular response

    Time frame: Up to 10 years

  • Allogeneic hematopoietic cell transplantation rate (Cohort 2)

    Time frame: Up to 10 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * STEP 0: Submission of bone marrow aspirate and peripheral blood for MRD analysis is mandatory prior to registration; the bone marrow sample should be from the first aspiration (i.e. first pull). Aspirate needle should be redirected if needed to get first pull bone marrow aspirate. It should be initiated as soon as possible after pre-registration. The specimens should be sent to the HEME Biobank. * Lumbar Puncture (Spinal Tap) and Intrathecal Methotrexate: * Patients may receive the day 1 of course IA dose of intrathecal (IT) methotrexate during the prior-to-registration lumbar puncture (or the venous line placement) to avoid a second lumbar puncture. If the dose is administered prior to registration, then systemic chemotherapy must begin within 7 days of this IT chemotherapy. * STEP 1: Morphologic diagnosis of precursor B-cell acute lymphoblastic leukemia (ALL) based on World Health Organization (WHO) criteria. Patients with Burkitt lymphoma/leukemia are not eligible. * STEP 1: CD22-positive disease defined as CD22 expression by \>= 20% of lymphoblasts by local hematopathology evaluation. * STEP 1: Philadelphia chromosome/BCR-ABL1-negative or Philadelphia chromosome/BCR-ABL1-positive B-cell ALL by cytogenetics, fluorescence in situ hybridization (FISH), and/or polymerase chain reaction (PCR). * STEP 1: No active central nervous system (CNS) leukemia (i.e. only CNS-1 disease allowed). Active CNS leukemia is defined as morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within 28 days prior to registration, symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurological dysfunction) within the 28 days prior to registration, and/or known asymptomatic parenchymal CNS mass lesions; see below for additional guidance. Prophylactic intrathecal medication alone is not an exclusion. * Categories of CNS Involvement for CNS Evaluation Prior to Registration: * CNS 1: CSF has \< 5 WBC/uL with cytospin negative for blasts; or \>= 10 red blood cell (RBC)/uL with cytospin negative for blasts. * CNS 2: CSF has \< 5 WBC/uL with cytospin positive for blasts; or \>= 10 RBC/uL with cytospin positive for blasts; or \>= 10 RBC/uL, WBC/uL \>= 5 but less than Steinherz/Bleyer algorithm with cytospin positive for blasts (see below). * CNS 3: CSF has \>= 5 WBC/uL with cytospin positive for blasts; or \>= 10 RBC/uL, \>= 5 WBC/uL and positive by Steinherz/Bleyer algorithm (see below); or clinical signs of CNS leukemia (such as facial nerve palsy, brain/eye involvement or hypothalamic syndrome). Steinherz/Bleyer Method of Evaluating Initial Traumatic Lumbar Punctures: * If the patient has leukemia cells in the peripheral blood and the lumbar puncture is traumatic and contains \>= 5 WBC/uL with blasts, the following algorithm should be used to define CNS disease: CSF WBC/CSF RBC \> 2 x (Blood WBC/Blood RBC count) * STEP 1: Patients with known or suspected testicular involvement by leukemia are allowed provided that the patient receives concomitant scrotal/testicular radiotherapy. * Unilateral or bilateral testicular enlargement should be assessed by ultrasound or other imaging technique. Biopsy is recommended if clinical findings are equivocal or suggestive of hydrocele or a non-leukemic mass, but further assessments are per treating physician discretion. * STEP 1: Not pregnant and not nursing. * This study involves agents that have known genotoxic, mutagenic, and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done =\< 7 days prior to registration is required. * STEP 1: Eastern Cooperative Oncology Group (ECOG) performance status: 0-2 * STEP 1: No unstable cardiac disease such as myocardial infarction, angina pectoris, uncontrolled heart failure, or uncontrolled cardiac arrhythmia within 6 months of registration. * STEP 1: No impaired cardiac function, defined as left ventricular ejection fraction (LVEF) \< 45% or New York Heart Association (NYHA) stage III or IV congestive heart failure (CHF). * STEP 1: Patients with known human immunodeficiency virus (HIV) infection are eligible if they have been on effective antiretroviral therapy with an undetectable viral load tested within 6 months of registration. * STEP 1: Patients with hepatitis B virus (HBV) are eligible only if they meet all the following: * On HBV-suppressive therapy. * No evidence of active virus. * No evidence of HBV-related liver damage. * STEP 1: Patients with hepatitis C virus (HCV) are eligible only if they meet all the following: * Successfully completed complete-eradication therapy with undetectable viral load. * No evidence of HCV-related liver damage. * STEP 1: No history of clinically relevant neurologic disorder such as epilepsy, seizure, aphasia, stroke, severe brain injury, structural brain abnormality, benign brain tumor, dementia, Parkinson's disease, movement disorder, cerebellar disease, or other significant CNS abnormalities. * STEP 1: No prior additional malignancy (i.e. in addition to ALL) except adequately treated basal- or squamous-cell skin cancer, in situ cervical cancer, stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for \>= 2 years. * STEP 1: No history of clinically significant ventricular arrhythmia, unexplained non-vasovagal syncope, or chronic bradycardic states such as sinoatrial block or higher degree of atrioventricular block unless a permanent pacemaker has been implanted. * STEP 1: No history of chronic liver disease, including cirrhosis. * STEP 1: No history of sinusoidal occlusion syndrome/veno-occlusive disease of the liver. * STEP 1: No uncontrolled infection or recent history (within 4 months prior to registration) of deep tissue infections such as fasciitis or osteomyelitis. * STEP 1: Total bilirubin, serum =\< 1.5 x upper limit of normal (ULN)\* * Except in the event of: 1) Gilbert disease, in which case total bilirubin must be =\< 2 x ULN, or 2) elevated bilirubin believed by investigator to be due to leukemic infiltration, in which case total bilirubin must be =\< 2 x ULN. * STEP 1: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN * STEP 1: Creatinine, serum =\< 1.5 ULN OR creatinine clearance \>= 40 mL/min * STEP 1: QT interval by Fridericia's correction formula (QTcF) =\< 470 msec * COHORT 1: Age \>= 60 years. * COHORT 1: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL. * COHORT 1: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed therapy may be administered for no more than 14 days and must be completed \>= 24 hours prior to the initiation of protocol therapy. * COHORT 1: No plan for allogeneic or autologous hematopoietic cell transplantation (HCT). * COHORT 2: Age \>= 18 years. * COHORT 2: Diagnosis of Philadelphia chromosome/BCR-ABL1-negative B-cell ALL. * COHORT 2: Relapsed or refractory disease in salvage 1 or 2. * COHORT 2: No isolated extramedullary relapse. * COHORT 2: Prior allogeneic HCT permitted. * COHORT 2: Patients with prior allogeneic HCT must have completed transplantation \>= 4 months prior to registration. * COHORT 2: Patients with prior allogeneic HCT must have no evidence of graft-versus-host disease and must have completed immunosuppressive therapy \>= 30 days prior to registration. * COHORT 2: Prior treatment with inotuzumab ozogamicin, blinatumomab, other CD22-directed therapy, or other CD19-directed therapy is not allowed. * COHORT 2: Prior treatment with rituximab must be completed \>= 7 days prior to registration. * COHORT 2: Prior treatment with other monoclonal antibodies must be completed \>= 6 weeks prior to registration. * COHORT 2: Prior treatment for ALL must be completed \>= 14 days prior to registration with the following exceptions: intrathecal chemotherapy, hydroxyurea, corticosteroids, 6-mercaptopurine, methotrexate, vincristine, and/or leukapheresis to reduce circulating absolute lymphoblast count to =\< 10,000/uL or prevent complications related to ALL are allowed but must be completed \>= 24 hours prior to the initiation of protocol therapy. * COHORT 2: Patients should have resolution of any acute non-hematologic toxicities of prior therapy to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0 grade =\< 1. * COHORT 2: Peripheral blood absolute lymphoblast count =\< 10,000/uL (treatment allowed as above to reduce blast count to =\< 10,000/uL) * COHORT 3: Age ≥ 75 years OR age ≥ 18 years AND ineligible for hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone (HyperCVAD) regimens * COHORT 3: Diagnosis of Philadelphia chromosome/BCR-ABL1-positive B-cell ALL * COHORT 3: No prior treatment for ALL except a single dose of intrathecal chemotherapy, corticosteroids, hydroxyurea, BCR-ABL1-targeted tyrosine kinase inhibitor, and/or leukapheresis to reduce peripheral blast count and prevent ALL complications. Allowed non-protocol therapy may be administered for no more than 14 days and must be completed ≥ 24 hours prior to the initiation of protocol therapy. * COHORT 3: No chronic, strong CYP3A4 inducers

Study locations (275)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233

Active Not Recruiting

Anchorage Associates in Radiation Medicine

Anchorage, Alaska, 98508

Suspended

Anchorage Radiation Therapy Center

Anchorage, Alaska, 99504

Suspended

Alaska Breast Care and Surgery LLC

Anchorage, Alaska, 99508

Suspended

Alaska Oncology and Hematology LLC

Anchorage, Alaska, 99508

Suspended

Alaska Women's Cancer Care

Anchorage, Alaska, 99508

Suspended

Anchorage Oncology Centre

Anchorage, Alaska, 99508

Suspended

Katmai Oncology Group

Anchorage, Alaska, 99508

Suspended

Providence Alaska Medical Center

Anchorage, Alaska, 99508

Suspended

Kingman Regional Medical Center

Kingman, Arizona, 86401

Suspended

Mercy Hospital Fort Smith

Fort Smith, Arkansas, 72903

Suspended

PCR Oncology

Arroyo Grande, California, 93420

Suspended

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, 91505

Suspended

Community Cancer Institute

Clovis, California, 93611

Active Not Recruiting

University Oncology Associates

Clovis, California, 93611

Active Not Recruiting

City of Hope Comprehensive Cancer Center

Duarte, California, 91010

Recruiting
Site Public Contact · Contact
Ibrahim Aldoss · Principal Investigator

UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care

Irvine, California, 92612

Recruiting
Site Public Contact · Contact
Deepa Jeyakumar · Principal Investigator

UC San Diego Moores Cancer Center

La Jolla, California, 92093

Recruiting
Site Public Contact · Contact
James K. Mangan · Principal Investigator

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868

Recruiting
Site Public Contact · Contact
Deepa Jeyakumar · Principal Investigator

Stanford Cancer Institute Palo Alto

Palo Alto, California, 94304

Active Not Recruiting

Beebe Medical Center

Lewes, Delaware, 19958

Suspended

Beebe South Coastal Health Campus

Millville, Delaware, 19967

Suspended

Delaware Clinical and Laboratory Physicians PA

Newark, Delaware, 19713

Suspended

Helen F Graham Cancer Center

Newark, Delaware, 19713

Recruiting
Site Public Contact · Contact
Gregory A. Masters · Principal Investigator

Medical Oncology Hematology Consultants PA

Newark, Delaware, 19713

Recruiting
Site Public Contact · Contact
Gregory A. Masters · Principal Investigator

Christiana Care Health System-Christiana Hospital

Newark, Delaware, 19718

Suspended

Beebe Health Campus

Rehoboth Beach, Delaware, 19971

Suspended

TidalHealth Nanticoke / Allen Cancer Center

Seaford, Delaware, 19973

Suspended

Christiana Care Health System-Wilmington Hospital

Wilmington, Delaware, 19801

Suspended

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

Recruiting
Site Public Contact · Contact
Kimberley Doucette · Principal Investigator

Holy Cross Hospital

Fort Lauderdale, Florida, 33308

Suspended

Jupiter Medical Center

Jupiter, Florida, 33458

Recruiting
Site Public Contact · Contact
Ryan H. Devine · Principal Investigator

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322

Recruiting
Site Public Contact · Contact
William G. Blum · Principal Investigator

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342

Recruiting
Site Public Contact · Contact
William G. Blum · Principal Investigator

Saint Luke's Cancer Institute - Boise

Boise, Idaho, 83712

Suspended

Saint Luke's Cancer Institute - Fruitland

Fruitland, Idaho, 83619

Suspended

Saint Luke's Cancer Institute - Meridian

Meridian, Idaho, 83642

Suspended

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, 83687

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Saint Luke's Cancer Institute - Nampa

Nampa, Idaho, 83687

Suspended

Saint Luke's Cancer Institute - Twin Falls

Twin Falls, Idaho, 83301

Suspended

OSF Saint Anthony's Health Center

Alton, Illinois, 62002

Suspended

Illinois CancerCare-Bloomington

Bloomington, Illinois, 61704

Suspended

Loyola Center for Health at Burr Ridge

Burr Ridge, Illinois, 60527

Suspended

Illinois CancerCare-Canton

Canton, Illinois, 61520

Suspended

Memorial Hospital of Carbondale

Carbondale, Illinois, 62902

Suspended

SIH Cancer Institute

Carterville, Illinois, 62918

Suspended

Illinois CancerCare-Carthage

Carthage, Illinois, 62321

Suspended

Centralia Oncology Clinic

Centralia, Illinois, 62801

Suspended

Northwestern University

Chicago, Illinois, 60611

Recruiting
Site Public Contact · Contact
Shira N. Dinner · Principal Investigator

University of Illinois

Chicago, Illinois, 60612

Recruiting
Site Public Contact · Contact
John G. Quigley · Principal Investigator

University of Chicago Comprehensive Cancer Center

Chicago, Illinois, 60637

Suspended

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, 62526

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Decatur Memorial Hospital

Decatur, Illinois, 62526

Suspended

Illinois CancerCare-Dixon

Dixon, Illinois, 61021

Suspended

Crossroads Cancer Center

Effingham, Illinois, 62401

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

Illinois CancerCare-Eureka

Eureka, Illinois, 61530

Suspended

Illinois CancerCare-Galesburg

Galesburg, Illinois, 61401

Suspended

Western Illinois Cancer Treatment Center

Galesburg, Illinois, 61401

Suspended

Loyola Medicine Homer Glen

Homer Glen, Illinois, 60491

Suspended

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, 61443

Suspended

Northwestern Medicine Lake Forest Hospital

Lake Forest, Illinois, 60045

Active Not Recruiting

Illinois CancerCare-Macomb

Macomb, Illinois, 61455

Suspended

Loyola University Medical Center

Maywood, Illinois, 60153

Recruiting
Site Public Contact · Contact
Stephanie B. Tsai · Principal Investigator

Marjorie Weinberg Cancer Center at Loyola-Gottlieb

Melrose Park, Illinois, 60160

Suspended

SSM Health Good Samaritan

Mount Vernon, Illinois, 62864

Suspended

UC Comprehensive Cancer Center at Silver Cross

New Lenox, Illinois, 60451

Recruiting
Wendy Stock · Principal Investigator

Cancer Care Center of O'Fallon

O'Fallon, Illinois, 62269

Suspended

University of Chicago Medicine-Orland Park

Orland Park, Illinois, 60462

Recruiting
Wendy Stock · Principal Investigator

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, 61350

Suspended

Illinois CancerCare-Pekin

Pekin, Illinois, 61554

Suspended

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, 61554

Suspended

Illinois CancerCare-Peoria

Peoria, Illinois, 61615

Recruiting
Site Public Contact · Contact
Bryan A. Faller · Principal Investigator

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, 61615

Suspended

Methodist Medical Center of Illinois

Peoria, Illinois, 61636

Suspended

OSF Saint Francis Medical Center

Peoria, Illinois, 61637

Suspended

Illinois CancerCare-Peru

Peru, Illinois, 61354

Suspended

Valley Radiation Oncology

Peru, Illinois, 61354

Suspended

Illinois CancerCare-Princeton

Princeton, Illinois, 61356

Suspended

Southern Illinois University School of Medicine

Springfield, Illinois, 62702

Suspended

Springfield Clinic

Springfield, Illinois, 62702

Suspended

Springfield Memorial Hospital

Springfield, Illinois, 62781

Suspended

Illinois CancerCare - Washington

Washington, Illinois, 61571

Suspended

Central Care Cancer Center - Garden City

Garden City, Kansas, 67846

Suspended

Central Care Cancer Center - Great Bend

Great Bend, Kansas, 67530

Suspended

University of Kansas Cancer Center

Kansas City, Kansas, 66160

Recruiting
Site Public Contact · Contact
Kenneth Byrd · Principal Investigator

University of Kansas Hospital-Westwood Cancer Center

Westwood, Kansas, 66205

Recruiting
Site Public Contact · Contact
Kenneth Byrd · Principal Investigator

Ochsner Medical Center Jefferson

New Orleans, Louisiana, 70121

Active Not Recruiting

University of Maryland/Greenebaum Cancer Center

Baltimore, Maryland, 21201

Active Not Recruiting

Mercy Medical Center

Springfield, Massachusetts, 01104

Suspended

Trinity Health Saint Joseph Mercy Hospital Ann Arbor

Ann Arbor, Michigan, 48106

Recruiting
Christopher M. Reynolds · Principal Investigator

Trinity Health IHA Medical Group Hematology Oncology - Brighton

Brighton, Michigan, 48114

Recruiting
Christopher M. Reynolds · Principal Investigator

Trinity Health Medical Center - Brighton

Brighton, Michigan, 48114

Recruiting
Christopher M. Reynolds · Principal Investigator

Trinity Health IHA Medical Group Hematology Oncology - Canton

Canton, Michigan, 48188

Recruiting
Christopher M. Reynolds · Principal Investigator

Trinity Health Medical Center - Canton

Canton, Michigan, 48188

Recruiting
Christopher M. Reynolds · Principal Investigator

Caro Cancer Center

Caro, Michigan, 48723

Suspended

Chelsea Hospital

Chelsea, Michigan, 48118

Recruiting
Christopher M. Reynolds · Principal Investigator

Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital

Chelsea, Michigan, 48118

Recruiting
Christopher M. Reynolds · Principal Investigator

Hematology Oncology Consultants-Clarkston

Clarkston, Michigan, 48346

Suspended

Newland Medical Associates-Clarkston

Clarkston, Michigan, 48346

Suspended

Henry Ford Health Saint John Hospital

Detroit, Michigan, 48236

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Henry Ford River District Hospital

East China Township, Michigan, 48054

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Cancer Hematology Centers - Flint

Flint, Michigan, 48503

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Genesee Hematology Oncology PC

Flint, Michigan, 48503

Suspended

Genesys Hurley Cancer Institute

Flint, Michigan, 48503

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Hurley Medical Center

Flint, Michigan, 48503

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Henry Ford Saint John Hospital - Academic

Grosse Pointe Woods, Michigan, 48236

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Henry Ford Saint John Hospital - Breast

Grosse Pointe Woods, Michigan, 48236

Suspended

Henry Ford Saint John Hospital - Van Elslander

Grosse Pointe Woods, Michigan, 48236

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

University of Michigan Health - Sparrow Lansing

Lansing, Michigan, 48912

Suspended

Hope Cancer Clinic

Livonia, Michigan, 48154

Suspended

Trinity Health Saint Mary Mercy Livonia Hospital

Livonia, Michigan, 48154

Recruiting
Christopher M. Reynolds · Principal Investigator

Henry Ford Saint John Hospital - Macomb Medical

Macomb, Michigan, 48044

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Henry Ford Warren Hospital - Breast Macomb

Macomb, Michigan, 48044

Suspended

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, 48453

Suspended

Hope Cancer Center

Pontiac, Michigan, 48341

Suspended

Michigan Healthcare Professionals Pontiac

Pontiac, Michigan, 48341

Suspended

Newland Medical Associates-Pontiac

Pontiac, Michigan, 48341

Suspended

Trinity Health Saint Joseph Mercy Oakland Hospital

Pontiac, Michigan, 48341

Recruiting
Christopher M. Reynolds · Principal Investigator

Henry Ford Rochester Hospital

Rochester Hills, Michigan, 48309

Suspended

MyMichigan Medical Center Saginaw

Saginaw, Michigan, 48601

Recruiting
Christopher M. Reynolds · Principal Investigator

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, 48604

Suspended

Bhadresh Nayak MD PC-Sterling Heights

Sterling Heights, Michigan, 48312

Suspended

MyMichigan Medical Center Tawas

Tawas City, Michigan, 48764

Recruiting
Christopher M. Reynolds · Principal Investigator

Advanced Breast Care Center PLLC

Warren, Michigan, 48088

Suspended

Henry Ford Health Warren Hospital

Warren, Michigan, 48093

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Henry Ford Madison Heights Hospital - Breast

Warren, Michigan, 48093

Suspended

Henry Ford Warren Hospital - GLCMS

Warren, Michigan, 48093

Recruiting
Site Public Contact · Contact
Christopher M. Reynolds · Principal Investigator

Macomb Hematology Oncology PC

Warren, Michigan, 48093

Suspended

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, 48661

Suspended

Huron Gastroenterology PC

Ypsilanti, Michigan, 48106

Recruiting
Christopher M. Reynolds · Principal Investigator

Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus

Ypsilanti, Michigan, 48197

Recruiting
Christopher M. Reynolds · Principal Investigator

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Completed

Mercy Oncology and Hematology - Clayton-Clarkson

Ballwin, Missouri, 63011

Suspended

Central Care Cancer Center - Bolivar

Bolivar, Missouri, 65613

Suspended

Cox Cancer Center Branson

Branson, Missouri, 65616

Suspended

Mercy Cancer Center - Cape Girardeau

Cape Girardeau, Missouri, 63703

Suspended

Saint Francis Medical Center

Cape Girardeau, Missouri, 63703

Suspended

Siteman Cancer Center at Saint Peters Hospital

City of Saint Peters, Missouri, 63376

Recruiting
Site Public Contact · Contact
Geoffrey L. Uy · Principal Investigator

Siteman Cancer Center at West County Hospital

Creve Coeur, Missouri, 63141

Recruiting
Site Public Contact · Contact
Geoffrey L. Uy · Principal Investigator

Parkland Health Center - Farmington

Farmington, Missouri, 63640

Suspended

MU Health Care Goldschmidt Cancer Center

Jefferson City, Missouri, 65109

Suspended

Freeman Health System

Joplin, Missouri, 64804

Suspended

Mercy Hospital Joplin

Joplin, Missouri, 64804

Suspended

Mercy Clinic-Rolla-Cancer and Hematology

Rolla, Missouri, 65401

Suspended

Phelps Health Delbert Day Cancer Institute

Rolla, Missouri, 65401

Suspended

Heartland Regional Medical Center

Saint Joseph, Missouri, 64506

Suspended

Sainte Genevieve County Memorial Hospital

Sainte Genevieve, Missouri, 63670

Suspended

Mercy Hospital Springfield

Springfield, Missouri, 65804

Suspended

CoxHealth South Hospital

Springfield, Missouri, 65807

Suspended

Mercy Infusion Center - Chippewa

St Louis, Missouri, 63109

Suspended

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting
Site Public Contact · Contact
Geoffrey L. Uy · Principal Investigator

Mercy Hospital South

St Louis, Missouri, 63128

Recruiting
Site Public Contact · Contact
Jay W. Carlson · Principal Investigator

Siteman Cancer Center-South County

St Louis, Missouri, 63129

Recruiting
Site Public Contact · Contact
Geoffrey L. Uy · Principal Investigator

Missouri Baptist Medical Center

St Louis, Missouri, 63131

Suspended

Siteman Cancer Center at Christian Hospital

St Louis, Missouri, 63136

Recruiting
Site Public Contact · Contact
Geoffrey L. Uy · Principal Investigator

Mercy Hospital Saint Louis

St Louis, Missouri, 63141

Recruiting
Site Public Contact · Contact
Jay W. Carlson · Principal Investigator

Missouri Baptist Sullivan Hospital

Sullivan, Missouri, 63080

Suspended

BJC Outpatient Center at Sunset Hills

Sunset Hills, Missouri, 63127

Suspended

Mercy Hospital Washington

Washington, Missouri, 63090

Suspended

Saint Patrick Hospital - Community Hospital

Missoula, Montana, 59802

Suspended

Nebraska Medicine-Village Pointe

Omaha, Nebraska, 68118

Active Not Recruiting

University of Nebraska Medical Center

Omaha, Nebraska, 68198

Active Not Recruiting

Carson Tahoe Regional Medical Center

Carson City, Nevada, 89703

Suspended

Cancer and Blood Specialists-Henderson

Henderson, Nevada, 89052

Suspended

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, 89052

Suspended

Comprehensive Cancer Centers of Nevada-Horizon Ridge

Henderson, Nevada, 89052

Suspended

Las Vegas Cancer Center-Henderson

Henderson, Nevada, 89052

Suspended

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, 89074

Suspended

Las Vegas Urology - Green Valley

Henderson, Nevada, 89074

Suspended

Las Vegas Urology - Pebble

Henderson, Nevada, 89074

Suspended

Oncology Las Vegas - Henderson

Henderson, Nevada, 89074

Suspended

Urology Specialists of Nevada - Green Valley

Henderson, Nevada, 89074

Suspended

Las Vegas Urology - Pecos

Las Vegas, Nevada, 89074

Suspended

Desert West Surgery

Las Vegas, Nevada, 89102

Suspended

OptumCare Cancer Care at Charleston

Las Vegas, Nevada, 89102

Recruiting
Site Public Contact · Contact
John A. Ellerton · Principal Investigator

University Medical Center of Southern Nevada

Las Vegas, Nevada, 89102

Suspended

Hope Cancer Care of Nevada

Las Vegas, Nevada, 89103

Suspended

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, 89106

Suspended

Urology Specialists of Nevada - Central

Las Vegas, Nevada, 89106

Suspended

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, 89109

Suspended

Sunrise Hospital and Medical Center

Las Vegas, Nevada, 89109

Suspended

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, 89113

Suspended

Las Vegas Prostate Cancer Center

Las Vegas, Nevada, 89113

Suspended

Las Vegas Urology - Sunset

Las Vegas, Nevada, 89113

Suspended

Urology Specialists of Nevada - Southwest

Las Vegas, Nevada, 89113

Suspended

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, 89119

Suspended

Ann M Wierman MD LTD

Las Vegas, Nevada, 89128

Suspended

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, 89128

Suspended

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, 89128

Suspended

Las Vegas Urology - Cathedral Rock

Las Vegas, Nevada, 89128

Suspended

Las Vegas Urology - Smoke Ranch

Las Vegas, Nevada, 89128

Suspended

Oncology Las Vegas - Tenaya

Las Vegas, Nevada, 89128

Suspended

OptumCare Cancer Care at MountainView

Las Vegas, Nevada, 89128

Suspended

Urology Specialists of Nevada - Northwest

Las Vegas, Nevada, 89128

Suspended

Alliance for Childhood Diseases/Cure 4 the Kids Foundation

Las Vegas, Nevada, 89135

Suspended

Comprehensive Cancer Centers of Nevada - Town Center

Las Vegas, Nevada, 89144

Suspended

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, 89144

Suspended

Summerlin Hospital Medical Center

Las Vegas, Nevada, 89144

Suspended

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, 89148-2405

Suspended

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89148

Suspended

HealthCare Partners Medical Group Oncology/Hematology-Centennial Hills

Las Vegas, Nevada, 89149

Suspended

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, 89169

Suspended

University Cancer Center

Las Vegas, Nevada, 89169

Suspended

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, 89183

Recruiting
Site Public Contact · Contact
John A. Ellerton · Principal Investigator

Hope Cancer Care of Nevada-Pahrump

Pahrump, Nevada, 89048

Suspended

Renown Regional Medical Center

Reno, Nevada, 89502

Suspended

Saint Mary's Regional Medical Center

Reno, Nevada, 89503

Suspended

Radiation Oncology Associates

Reno, Nevada, 89509

Suspended

Roswell Park Cancer Institute

Buffalo, New York, 14263

Active Not Recruiting

Northwell Health/Center for Advanced Medicine

Lake Success, New York, 11042

Recruiting
Site Public Contact · Contact
Bradley H. Goldberg · Principal Investigator

North Shore University Hospital

Manhasset, New York, 11030

Recruiting
Site Public Contact · Contact
Bradley H. Goldberg · Principal Investigator

Long Island Jewish Medical Center

New Hyde Park, New York, 11040

Recruiting
Site Public Contact · Contact
Bradley H. Goldberg · Principal Investigator

NYP/Weill Cornell Medical Center

New York, New York, 10065

Active Not Recruiting

University of Rochester

Rochester, New York, 14642

Recruiting
Site Public Contact · Contact
Paul M. Barr · Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27599

Suspended

Duke University Medical Center

Durham, North Carolina, 27710

Active Not Recruiting

East Carolina University

Greenville, North Carolina, 27834

Suspended

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157

Recruiting
Site Public Contact · Contact
Bayard L. Powell · Principal Investigator

University of Cincinnati Cancer Center-UC Medical Center

Cincinnati, Ohio, 45219

Recruiting
Site Public Contact · Contact
Emily K. Curran · Principal Investigator

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210

Recruiting
Site Public Contact · Contact
Gregory K. Behbehani · Principal Investigator

University of Cincinnati Cancer Center-West Chester

West Chester, Ohio, 45069

Recruiting
Site Public Contact · Contact
Emily K. Curran · Principal Investigator

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104

Recruiting
Site Public Contact · Contact
Adam S. Asch · Principal Investigator

Mercy Hospital Oklahoma City

Oklahoma City, Oklahoma, 73120

Suspended

Saint Charles Health System

Bend, Oregon, 97701

Suspended

Clackamas Radiation Oncology Center

Clackamas, Oregon, 97015

Recruiting
Site Public Contact · Contact
Alison K. Conlin · Principal Investigator

Providence Cancer Institute Clackamas Clinic

Clackamas, Oregon, 97015

Suspended

Bay Area Hospital

Coos Bay, Oregon, 97420

Suspended

Providence Newberg Medical Center

Newberg, Oregon, 97132

Recruiting
Site Public Contact · Contact
Alison K. Conlin · Principal Investigator

Providence Willamette Falls Medical Center

Oregon City, Oregon, 97045

Recruiting
Site Public Contact · Contact
Alison K. Conlin · Principal Investigator

Providence Portland Medical Center

Portland, Oregon, 97213

Recruiting
Site Public Contact · Contact
Alison K. Conlin · Principal Investigator

Providence Saint Vincent Medical Center

Portland, Oregon, 97225

Recruiting
Site Public Contact · Contact
Alison K. Conlin · Principal Investigator

Oregon Health and Science University

Portland, Oregon, 97239

Active Not Recruiting

Saint Charles Health System-Redmond

Redmond, Oregon, 97756

Suspended

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, 18103

Suspended

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, 18017

Suspended

Christiana Care Health System-Concord Health Center

Chadds Ford, Pennsylvania, 19317

Suspended

Pocono Medical Center

East Stroudsburg, Pennsylvania, 18301

Suspended

Lehigh Valley Hospital-Hazleton

Hazleton, Pennsylvania, 18201

Suspended

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107

Active Not Recruiting

VCU Massey Comprehensive Cancer Center

Richmond, Virginia, 23298

Recruiting
Site Public Contact · Contact
Keri R. Maher · Principal Investigator

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, 98520

Suspended

Overlake Medical Center

Bellevue, Washington, 98004

Suspended

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, 98225

Suspended

Providence Regional Cancer System-Centralia

Centralia, Washington, 98531

Suspended

Swedish Cancer Institute-Edmonds

Edmonds, Washington, 98026

Suspended

Providence Regional Cancer Partnership

Everett, Washington, 98201

Suspended

Swedish Cancer Institute-Issaquah

Issaquah, Washington, 98029

Suspended

Kadlec Clinic Hematology and Oncology

Kennewick, Washington, 99336

Suspended

Providence Regional Cancer System-Lacey

Lacey, Washington, 98503

Suspended

PeaceHealth Saint John Medical Center

Longview, Washington, 98632

Suspended

Valley Medical Center

Renton, Washington, 98055

Suspended

Pacific Gynecology Specialists

Seattle, Washington, 98104

Suspended

Swedish Medical Center-Ballard Campus

Seattle, Washington, 98107

Suspended

Swedish Medical Center-Cherry Hill

Seattle, Washington, 98122-5711

Suspended

Swedish Medical Center-First Hill

Seattle, Washington, 98122

Suspended

PeaceHealth United General Medical Center

Sedro-Woolley, Washington, 98284

Suspended

Providence Regional Cancer System-Shelton

Shelton, Washington, 98584

Suspended

PeaceHealth Southwest Medical Center

Vancouver, Washington, 98664

Suspended

Providence Saint Mary Regional Cancer Center

Walla Walla, Washington, 99362

Suspended

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, 98902

Suspended

Providence Regional Cancer System-Yelm

Yelm, Washington, 98597

Suspended

West Virginia University Healthcare

Morgantown, West Virginia, 26506

Recruiting
Site Public Contact · Contact
Ashkan Emadi · Principal Investigator

Marshfield Medical Center-EC Cancer Center

Eau Claire, Wisconsin, 54701

Recruiting
Kareem H. Abdelhadi · Principal Investigator

University of Wisconsin Carbone Cancer Center - Eastpark Medical Center

Madison, Wisconsin, 53718

Active Not Recruiting

University of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, 53792

Active Not Recruiting

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, 54449

Recruiting
Kareem H. Abdelhadi · Principal Investigator

Froedtert Menomonee Falls Hospital

Menomonee Falls, Wisconsin, 53051

Recruiting
Site Public Contact · Contact
Ehab L. Atallah · Principal Investigator

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

Recruiting
Site Public Contact · Contact
Ehab L. Atallah · Principal Investigator

Marshfield Medical Center - Minocqua

Minocqua, Wisconsin, 54548

Recruiting
Kareem H. Abdelhadi · Principal Investigator

Froedtert and MCW Moorland Reserve Health Center

New Berlin, Wisconsin, 53151

Recruiting
Site Public Contact · Contact
Ehab L. Atallah · Principal Investigator

Drexel Town Square Health Center

Oak Creek, Wisconsin, 53154

Recruiting
Site Public Contact · Contact
Ehab L. Atallah · Principal Investigator

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, 54868

Suspended

Marshfield Medical Center-River Region at Stevens Point

Stevens Point, Wisconsin, 54482

Recruiting
Kareem H. Abdelhadi · Principal Investigator

Froedtert West Bend Hospital/Kraemer Cancer Center

West Bend, Wisconsin, 53095

Recruiting
Site Public Contact · Contact
Ehab L. Atallah · Principal Investigator

Marshfield Medical Center - Weston

Weston, Wisconsin, 54476

Recruiting
Kareem H. Abdelhadi · Principal Investigator

References

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067.(PubMed)
  • Wieduwilt MJ, Yin J, Kour O, Teske R, Stock W, Escherich C, Yang J, Li Z, Byrd K, Doucette K, Mangan J, Hall S, Mims AS, Jamieson K, Dinner SN, Bseiso AW, Giordano G, Saygin C, Uy GL, Litzow MR, Stone RM. Inotuzumab Ozogamicin Then Blinatumomab for Older Adults With Newly Diagnosed B-Cell ALL: Alliance Study A041703 Cohort 1 Results. J Clin Oncol. 2025 Nov 10;43(32):3526-3535. doi: 10.1200/JCO-25-00307. Epub 2025 Sep 30.(PubMed)
  • Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.(PubMed)