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NCT07454226Recruiting

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

An Open-Label, Single-Arm, Phase II Exploratory Study of ABL and JAK Kinase Inhibitors With Chemotherapy and Venetoclax in Adult Patients With Ph-like ALL

Source: ClinicalTrials.gov · Last updated 13 May 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
92 (estimated)
First submitted
26 Feb 2026
Start date
30 May 2026
Primary completion date
1 Mar 2028
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
NCT number
NCT07454226

What you commit to

  • Study type: Interventional
  • Planned participants: 92
  • From 30 May 2026 to the primary completion date, 1 Mar 2028
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Other

  • Pregnant women

Who the study is looking for

  • 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

Age in the registry: 14 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Blood Diseases Hospital
Coordinator of this site? Confirm its status
TianjinChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.