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RecruitingInterventionalPhase 3

A Pivotal Registrational Phase 3 Study of Olverembatinib Combined With Chemotherapy Versus Investigator's Choice of TKI Combined With Chemotherapy in Patients With Newly Diagnosed Ph+ ALL

NCT ID: NCT06051409Sponsor: Ascentage Pharma Group Inc.Last updated: 2026-04-30

Summary

A global multicenter, open-label, randomized and registrational Phase 3 study to evaluate efficacy and safety of olverembatinib combined with chemotherapy versus investigator's choice of tyrosine kinase inhibitor (TKI) combined with chemotherapy in subjects with newly-diagnosed Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL).

Detailed description

Comparing efficacy and safety of olverembatinib in combination with chemotherapy (investigational arm) vs. investigator's choice of TKI in combination with chemotherapy (control arm).

Arms & interventions

  • DrugOlverembatinib

    Oral (PO) once every other day (QOD).

  • DrugInvestigator's choice of TKI

    Oral (PO) once daily (QD).

Outcome measures

Primary

  • Minimal Residual Disease Negative CR Rate

    The minimal residual disease negative CR rate of olverembatinib combined with chemotherapy versus investigator's choice of TKI combined with chemotherapy in subjects with newly diagnosed Ph+ALL.

    Time frame: Cycle 1 to Cycle 3 (each cycle is 28 days)

Secondary

  • Event-free Survival (EFS)

    Time frame: Baseline up to 3 to 6 years

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

    Time frame: Through study completion (approximately 2 years)

  • Plasma concentrations of olverembatinib

    Time frame: Cycle 1 to Cycle 3 (each cycle is 28 days)

  • FACT-Leu (Functional Assessment of Cancer Therapy - Leukemia) Score

    Time frame: Through study completion (approximately 2 years)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: 1. Newly diagnosed Philadelphia chromosome-positive (Ph+) Acute Lymphoblastic Leukemia (ALL) 2. Expected survival of at least 3 months 3. ECOG ≤ 2 4. Adequate organ function Exclusion Criteria: 1. A history of chronic myeloid leukemia (CML) 2. Clinical manifestations of central nervous system (CNS) leukemia or ALL extramedullary infiltration, except lymphadenopathy or hepatosplenomegaly 3. Previous or current clinical CNS diseases 4. Autoimmune diseases that may involve the CNS 5. Use of therapeutic doses of anticoagulants and/or antiplatelet agents; low doses of anticoagulants or antiplatelet agents are allowed 6. Use a therapeutic drug that has drug interaction with the investigational drug due to other diseases within 7 days or within 5 half-lives (whichever is shorter) prior to the first receipt of the investigational drug 7. Uncontrolled heart diseases 8. Any venous thromboembolism in the 6 months prior to randomization, including but not limited to deep vein thrombosis (DVT) or pulmonary embolism 9. Use of prohibited drugs 10. Disease or medical condition that is unstable or may affect its safety or compliance with the study 11. Use of medications known to cause prolonged QT interval 12. Active infections requiring systemic treatment 13. Disease that severely affects the oral administration and absorption of drugs, or an active gastrointestinal ulcer 14. Contraindications to the use of glucocorticoids 15. Bleeding disorders unrelated to ALL 16. Plan to undergo major surgery 17. Allergy to drug ingredients, excipients, or their analogues in the study 18. Female subjects who are pregnant or breastfeeding or expect to become pregnant during the study period 19. Other malignant tumors within 2 years 20. Any symptom or illness that may interfere with the evaluation of the efficacy and safety of the investigational drug, or any other condition or condition that is not appropriate for participation in the study

Study locations (16)

Ascentage Investigative Site #1044

Birmingham, Alabama, 35233

Not Yet Recruiting

Ascentage Investigative Site #1062

Duarte, California, 91010

Not Yet Recruiting

Ascentage Investigative Site #1134

Los Angeles, California, 90048

Not Yet Recruiting

Ascentage Investigative Site #1059

Los Angeles, California, 90095

Not Yet Recruiting

Ascentage Investigative Site #1142

Miami, Florida, 33155

Not Yet Recruiting

Ascentage Investigative Site #1045

Augusta, Georgia, 30912

Not Yet Recruiting

Ascentage Investigative Site #1158

Indianapolis, Indiana, 46202

Not Yet Recruiting

Ascentage Investigative Site #1069

Indianapolis, Indiana, 46237

Not Yet Recruiting

Ascentage Investigative Site #1084

Lexington, Kentucky, 40536

Not Yet Recruiting

Ascentage Investigative Site #1064

Hackensack, New Jersey, 07601

Not Yet Recruiting

Ascentage Investigative Site #1098

New Brunswick, New Jersey, 08901

Not Yet Recruiting

Ascentage Investigative Site #1160

Stony Brook, New York, 11794

Not Yet Recruiting

Ascentage Investigative Site #1151

The Bronx, New York, 10461

Not Yet Recruiting

Ascentage Investigative Site #1501

Houston, Texas, 77030

Not Yet Recruiting

Ascentage Investigative Site #1806

Seattle, Washington, 98104

Not Yet Recruiting

Ascentage Investigative Site #1155

Morgantown, West Virginia, 26506

Not Yet Recruiting