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

ConditionPrecursor B-Cell Acute Lymphoblastic Leukemia

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

Precursor B cell acute lymphoblastic leukemia (B-ALL) is an aggressive type of leukemia, with high relapse rate and poor long term survival in adults. Philadelphia chromosome positive (Ph+) ALL is defined as ALL with translocation between chromosomes 9 and 22. And t(9;22)(q34;q11) is the most common chromosomal abnormality in ALL. Before the emergence of TKI, the prognosis of Ph+ ALL was extremely poor, and the long-term survival rate was only 10%-35%. Ph+ ALL accounts for about 30% of adult ALL. In this study, the investigators propose a treatment approach that combines Venetoclax with Olverembatinib and Predinisone in Ph+ B-ALL adults. The study aims to answer the safety and efficacy of this treatment regimen, and further improve the survival for those participants.

Eligibility criteria

Qualifiers

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;

Age ≥ 18 years;

Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2;

Expected survival time ≥ 3 months;

Disqualifiers

Accelerated phase or blast crisis of chronic myeloid leukemia;

Subjects with involvement of the central nervous system (CNS) or accompanied by extramedullary lesions;

Subjects who have received systemic anti-leukemia treatment (including but not limited to TKI, radiotherapy or chemotherapy, except for the allowed pretreatment);

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%;

Trial design

Treatments tested in this trial

Venetoclax
Olverembatinib
Predinisone

Treatment groups

36 Participants

are divided into 1 treatment group

Sponsors and collaborators

First Affiliated Hospital of Zhejiang University

Lead sponsor

Source ClinicalTrials.gov