Venetoclax Combined With Olverembatinib and Predinisone in Treating Ph+ B-ALL

Launched by FIRST AFFILIATED HOSPITAL OF ZHEJIANG UNIVERSITY · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment approach for adults with Philadelphia chromosome positive (Ph+) precursor B-cell acute lymphoblastic leukemia (B-ALL), a serious form of leukemia. The treatment combines three medications: Venetoclax, Olverembatinib, and Prednisone. The goal of the study is to see if this combination is safe and effective in helping patients live longer and improve their quality of life.

To participate in the trial, individuals must be at least 18 years old and have been diagnosed with Ph+ B-ALL, meaning they have a specific genetic change in their leukemia cells. Participants should be in reasonably good health with an expected survival time of at least three months. They also need to understand the study and agree to take part. If you or someone you know is considering joining this trial, it's important to discuss it with a healthcare provider to see if it’s a good fit based on individual health needs and circumstances.

Gender

ALL

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.