Actively Recruiting
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
Eligibility Criteria
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
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Blood diseases hospital
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
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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