Combining Venetoclax, Olverembatinib, and Prednisone for treating Ph+ B-ALL

Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph-positive Precursor B Cell Acute Lymphoblastic Leukemia: a Phase II, Single Arm and Multicenter Study

This study is testing a new combination of three drugs to see if it can help adults with a specific type of aggressive leukemia feel better and live longer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: chemotherapy, Olverembatinib, prednisone
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06754267 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older diagnosed with de novo Ph+ B-ALL.

Not a fit: Patients with accelerated phase or blast crisis of chronic myeloid leukemia may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve survival rates for adults with Ph+ B-ALL.

How similar studies have performed: Other studies have shown promising results with similar multi-drug combinations in treating Ph+ B-ALL, indicating potential for success.

Eligibility criteria

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 this trial is running

Hangzhou, Zhejiang

• 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.

Conditions Precursor B-Cell Acute Lymphoblastic Leukemia; acute lymphoblastic leukemia; Ph chromosome; BCL2 inhibitor; TKI