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Evaluating Olverembatinib for Newly Diagnosed Ph+ ALL

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

Phase 3 Interventional Ascentage Pharma Group Inc. · NCT06051409

This study is testing if a new drug called Olverembatinib, used with chemotherapy, can help people with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia do better than the standard treatment with Imatinib and chemotherapy.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment350 (estimated)
Ages18 Years and up
SexAll
SponsorAscentage Pharma Group Inc. Industry-sponsored
Drugs / interventionsolverembatinib, chemotherapy
Locations90 sites (Birmingham, Alabama and 89 other locations)
Trial IDNCT06051409 on ClinicalTrials.gov

What this trial studies

This Phase 3 clinical trial is a global multicenter, open-label, randomized study designed to assess the efficacy and safety of Olverembatinib in combination with chemotherapy compared to Imatinib combined with chemotherapy in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). Participants will be randomly assigned to receive either the investigational drug Olverembatinib or the control drug Imatinib, both alongside standard chemotherapy. The study aims to determine which treatment provides better outcomes for patients with this specific type of leukemia.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals who have been newly diagnosed with Ph+ ALL and meet specific eligibility criteria.

Not a fit: Patients with a history of chronic myeloid leukemia or those with clinical manifestations of CNS leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options and outcomes for patients with newly diagnosed Ph+ ALL.

How similar studies have performed: Previous studies have shown promising results with similar approaches, but this specific combination of Olverembatinib and chemotherapy is being evaluated for the first time in this context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Birmingham, Alabama and 89 other locations

+40 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ph+ ALLLeukemia, Lymphoblastic, Acute, Philadelphia-PositiveOlverembatinibAcute lymphoblastic leukemiaBcr-Abl Tyrosine Kinase
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.