Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haplo-Identical Transplantation for Patients With Hematologic Malignancies

NCT ID: NCT05417971Sponsor: Northside Hospital, Inc.Last updated: 2026-04-16

Summary

This trial will evaluate the safety and efficacy of RIC HIDT transplant protocol following fludarabine and intermediate-dose TBI 800 cGy utilizing PBSC as the stem cell source.

Arms & interventions

  • OtherFludarabine

    Reduced-intensity fludarabine with intermediate-dose TBI

Outcome measures

Primary

  • Compare the time to recovery of circulating neutrophils and platelets of all patients to determine incidence of graft rejection

    Time frame: 30 days after transplant

Secondary

  • Number of patients who are still alive as assessed by survival status at certain timepoints after transplant

    Time frame: 36 months after transplant

  • Number of patients with relapsed disease as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant

    Time frame: 36 months after transplant

  • Number of patients with evidence of graft versus host disease as assessed by weekly progress notes after transplant

    Time frame: 36 months after transplant

  • Number of participants who died in the absence of relapse or progression as assessed by survival status at certain timepoints after transplant

    Time frame: 1 year after transplant

  • Number of participants with responses to treatment as assessed by labs, bone marrow biopsies and radiological scans at certain timepoints after transplant

    Time frame: 36 months after transplant

  • Number of participants with treatment-related adverse events as assessed by CTCAE v.5.0

    Time frame: 90 days after transplant

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Availability of 3/6 - 5/6 matched related donor with a negative HLA-cross match in the host vs. graft direction willing to donate peripheral blood stem cells * KPS \>/= 70% * Hematologic malignancy requiring allogeneic transplantation, with a predicted high risk of relapse following non-myeloablative, low intensity conditioning. Exclusion Criteria: * Poor cardiac function (LVEF \<45%) * Poor pulmonary function (FEV, FVC, DLCO \<60%) * Poor liver function (bilirubin \>/= 2.5mg/dL; AST or ALT \>3xULN) * Poor renal function (creatinine clearance \<40mL/min) * HIV-positive; active HepB or HepC * Uncontrolled infection * Pregnant female or not able to practice adequate contraception * Debilitating medical or psychiatric illness which would preclude their giving informed consent

Study locations (1)

Caitlin Guzowski

Atlanta, Georgia, 30342

Recruiting
Caitlin Guzowski, MBA, MHA · Contact
404-851-8523caitlin.guzowski@northside.com
H. Kent Holland, MD · Sub Investigator
Asad Bashey, MD · Sub Investigator
Lawrence E Morris, MD · Sub Investigator
Scott Solomon, MD · Sub Investigator
Melhem Solh, MD · Principal Investigator
Lizamarie Bachier-Rodriguez, MD · Sub Investigator