RecruitingPhase 2NCT06754267

Venetoclax Combined With Olverembatinib and Predinisone in 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


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

36 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination of three drugs — venetoclax, olverembatinib (a BCR-ABL inhibitor), and prednisone — for adults newly diagnosed with Philadelphia chromosome-positive B-cell acute lymphoblastic leukemia (Ph+ B-ALL), a type of fast-growing blood cancer. **You may be eligible if...** - You are 18 or older - You have a new diagnosis of Philadelphia chromosome-positive B-cell ALL (confirmed by genetic testing) - You are in good enough health to participate (ECOG 0–2) with expected survival of at least 3 months - Your organ function is within required ranges **You may NOT be eligible if...** - Your leukemia is an advanced-stage chronic myeloid leukemia (accelerated phase or blast crisis) - Your leukemia has spread to the brain or spinal fluid - You have had prior systemic anti-leukemia treatment (other than allowed pre-treatment) - You had a heart attack within the past 12 months or have significant heart disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGVenetoclax

BCL-2 inhibotor

DRUGOlverembatinib

Tyrosine kinase inhibitor

DRUGPredinisone

Glucocorticoids


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06754267


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