RecruitingNot Applicable

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

China92 participantsStarted 2026-05-30

Plain-language summary

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.

Who can participate

Age range

14 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥14 years and ≤60 years, regardless of gender * ECOG performance status score ≤2 * Male and female participants of childbearing potential agree to and adopt effective contraceptive measures * Criteria for major organ function assessment: total bilirubin \<1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 × ULN; serum creatinine \<2 × ULN; myocardial enzymes \<2 × ULN; serum amylase ≤1.5 × ULN; left ventricular ejection fraction (LVEF) \>45% as shown by cardiac ultrasound Exclusion Criteria: * Pregnant women * Severe uncontrolled active infections * Mental illnesses that may hinder the completion of treatment or informed consent * Other conditions deemed unsuitable for this study by the investigator

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of flow cytometry-minimal residual disease (flow-MRD) negative complete remission at 3 months after treatment initiation

Timeframe: At 3 months after treatment initiation

Trial details

NCT IDNCT07454226

SponsorInstitute of Hematology & Blood Diseases Hospital, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-01

Contact for this trial

Hui Wei, MD

13132507161 weihui@ihcams.ac.cn

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