Actively Recruiting

Phase Not Applicable
Age: 14Years - 60Years
All Genders
NCT07454226

ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2026-05-13

92

Participants Needed

1

Research Sites

195 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This open-label, non-randomized, phase II exploratory study aims to evaluate the efficacy and safety of combining pathway-specific tyrosine kinase inhibitors with chemotherapy and venetoclax in patients with newly diagnosed Ph-like acute lymphoblastic leukemia (ALL). Patients are stratified by genetic alteration: those with ABL class fusions (ABL1, ABL2, PDGFRA, PDGFRB) receive olverembatinib, while those with JAK pathway alterations (CRLF2 rearrangement, JAK mutation/fusion, EPOR fusion, SH2B3 deletion, IL7R mutation) receive Gecacitinib. Both groups undergo sequential induction, consolidation, intensification, and maintenance therapy as per protocol. The primary endpoint is the rate of flow cytometry minimal residual disease (MRD)-negative complete remission (CR MRD-) at 3 months after induction therapy. Secondary endpoints include overall complete remission rate, NGS MRD-negative CR rate at 3 months, overall survival (OS), disease-free survival (DFS), relapse-free survival (RFS), cumulative incidence of relapse, and 60-day mortality.

CONDITIONS

Official Title

ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL

Who Can Participate

Age: 14Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 14 to 60 years, any gender
  • ECOG performance status score of 2 or less
  • Male and female participants of childbearing potential agree to use effective contraception
  • Major organ function within limits: total bilirubin under 1.5 times upper limit of normal, AST and ALT under 2.5 times ULN, serum creatinine under 2 times ULN, myocardial enzymes under 2 times ULN, serum amylase under 1.5 times ULN
  • Left ventricular ejection fraction over 45% as shown by cardiac ultrasound
Not Eligible

You will not qualify if you...

  • Pregnant women
  • Severe uncontrolled active infections
  • Mental illnesses that may prevent completion of treatment or informed consent
  • Any other condition considered unsuitable for this study by the investigator

AI-Screening

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Trial Site Locations

Total: 1 location

1

Blood diseases hospital

Tianjin, Tianjin Municipality, China, 300020

Actively Recruiting

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Research Team

H

Hui Wei, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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