Combining Venetoclax, Olverembatinib, and Prednisone for treating Ph+ B-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 clinical trial investigates a new treatment regimen for adults with Philadelphia chromosome-positive precursor B-cell acute lymphoblastic leukemia (Ph+ B-ALL). The study combines three drugs: Venetoclax, Olverembatinib, and Prednisone, aiming to improve safety and efficacy outcomes. A total of 36 participants will be enrolled, and the primary goal is to achieve a complete molecular response after three treatment cycles. This approach seeks to enhance survival rates for patients diagnosed with this aggressive form of leukemia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Before enrollment, the patient must be diagnosed with de novo precursor B-cell acute lymphoblastic leukemia and positive for Philadelphia chromosome (presence of t(9;22) and/or BCR::ABL1 positive and/or FISH positive). The diagnostic criteria refer to the 2022 WHO classification;
2. Age ≥ 18 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;
4. Expected survival time ≥ 3 months;
5. No organ dysfunction that would restrict the use of this protocol during the screening period;
6. Understand the study and sign the informed consent form.
7. Men, women of childbearing age (only postmenopausal women who have been menopausal for at least 12 months can be considered infertile), and their partners voluntarily take effective contraceptive measures deemed effective by the investigator during the treatment period and for at least 12 months after the last dose of the study drug.

Exclusion Criteria:

1. Accelerated phase or blast crisis of chronic myeloid leukemia;
2. Subjects with involvement of the central nervous system (CNS) or accompanied by extramedullary lesions;
3. Subjects who have received systemic anti-leukemia treatment (including but not limited to TKI, radiotherapy or chemotherapy, except for the allowed pretreatment);
4. Subjects with a history of myocardial infarction within 12 months, or have clinical manifestations of heart disease (including but not limited to unstable angina pectoris, congestive heart failure, uncontrolled hypertension and uncontrolled arrhythmia, etc.); left ventricular ejection fraction (LVEF) on echocardiography \<50%;
5. Diseases with abnormal functions of organs such as lung, liver, and kidney that may limit the patient's participation in this trial (including but not limited to severe infection, uncontrolled diabetes, active tuberculosis, asthma, COPD, bronchiectasis, etc.);
6. History of other malignancies within the past 5 years, excluding localized thyroid cancer and in situ skin cancer;
7. Serum total bilirubin \> 1.5 ULN (upper limit of normal); ALT or AST \> 2.5 ULN; serum creatinine \> 1.5 ULN;
8. Known HIV infection;
9. Conditions affecting the use of the study drug as assessed by the investigator;
10. Unable to understand or comply with the study protocol.

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Jie Jin — Zhejiang University
• Study coordinator: Jie Jin, M.D.
• Email: jiej0503@163.com
• Phone: +8657187236896

Similar studies

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

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• Olverembatinib for treating SDH-deficient GIST

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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.