Low-intensity chemotherapy with olverembatinib, venetoclax and blinatumomab for newly diagnosed Philadelphia chromosome–positive ALL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, open‑label, randomized 1:1 trial for patients ≥14 years with newly diagnosed Philadelphia chromosome–positive acute lymphoblastic leukemia and adequate organ function. All participants receive continuous olverembatinib and a low‑intensity chemotherapy backbone (vincristine and prednisone), with randomization to receive or not receive venetoclax during the first three induction/consolidation cycles; up to four cycles of blinatumomab may begin from cycle four and allo‑HSCT is allowed per physician decision. The co‑primary endpoints are the proportion of patients achieving BCR::ABL1 ≤0.01% at 90 days and event‑free survival, and secondary endpoints include overall survival, relapse‑free survival, molecular relapse rate, NGS MRD negativity, and cardiovascular events. The trial excludes patients with significant recent cardiac events, uncontrolled infection, prior systemic anti‑leukemic therapy (except limited cytoreduction), or other medical/psychiatric conditions that would prevent protocol therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH).
* Age ≥ 14 years.
* ECOG performance status ≤ 2.
* Adequate organ function: Total bilirubin \<1.5x ULN; AST/ALT ≤2.5x ULN; Serum creatinine \<2x ULN; Cardiac enzymes \<2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) \>45%.
* Male and female patients of childbearing potential must agree to use effective contraception.
* Signed informed consent.

Exclusion Criteria:

* Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase.
* Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment).
* Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia.
* Uncontrolled active severe infection.
* Active psychiatric illness that may hinder treatment completion or informed consent.
* Any other condition deemed unsuitable for the study by the investigator.

Where it's running

• Blood Diseases Hospital
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Hui Wei, MD
• Email: weihui@ihcams.ac.cn
• Phone: 13132507161

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Evaluating Olverembatinib for Newly Diagnosed Ph+ ALL

  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.

  Recruiting at 8 sites Phase 3 Ascentage Pharma Group Inc. · Birmingham, Alabama and 89 other locations · NCT06051409

• Long-term outcomes after treatment for relapsed or refractory Ph+ ALL

  This project looks back at adults with relapsed or refractory Philadelphia chromosome–positive (Ph+) ALL to see which treatment and response patterns link to better long-term outcomes.

  Recruiting Group for Research in Adult Acute Lymphoblastic Leukemia · Pierre-Bénite · NCT07433400

• Combination treatment for BCR-ABL positive B-cell leukemia and chronic myeloid leukemia

  This study is testing a new combination treatment for people with BCR-ABL positive B-cell leukemia or chronic myeloid leukemia to see if it helps them feel better and works well with existing medications.

  Recruiting at 4 sites Phase 1 Dana-Farber Cancer Institute · Chicago, Illinois and 3 other locations · NCT03595917

• Treatment plan for newly diagnosed pediatric Philadelphia chromosome–positive B‑cell acute lymphoblastic leukemia

  This Phase 3 effort tests a chemotherapy‑light approach using olverembatinib together with blinatumomab and intermittent venetoclax to see if children and adolescents newly diagnosed with Ph+ B‑ALL can be cured with less toxicity.

  Recruiting Phase 3 Institute of Hematology & Blood Diseases Hospital, China · Hefei, Anhui and 23 other locations · NCT07152041

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.