ABL‑ or JAK‑targeted drugs with chemotherapy and venetoclax for Ph‑like ALL
Official title: 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
Run by Institute of Hematology & Blood Diseases Hospital, China · NCT07454226 · Data updated 2026-11-12
This protocol tests whether adding an ABL‑targeted or JAK‑targeted drug plus venetoclax to standard chemotherapy helps people aged 14–60 with newly diagnosed Ph‑like acute lymphoblastic leukemia get deeper remissions.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years to 60 Years |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China Academic / other |
| Drugs / interventions | olverembatinib, Gecacitinib, chemotherapy |
| Locations | 1 site (Tianjin, Tianjin Municipality) |
| Status | Recruiting |
| Started | May 30, 2026 |
| Main results expected | March 1, 2028 |
| Study ends | March 1, 2030 |
| Registry record updated | May 13, 2026 |
| Trial ID | NCT07454226 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are people aged 14–60 with newly diagnosed Ph‑like ALL who have adequate organ function, ECOG performance status ≤2, and a qualifying ABL‑class or JAK‑pathway genetic alteration.
✕Probably not a fit
Patients who are pregnant, have severe uncontrolled infections, major comorbidities, poor organ function, or who do not have Ph‑like or targetable ABL/JAK alterations are unlikely to benefit from this regimen.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This open‑label, non‑randomized phase II study enrolls patients with newly diagnosed Ph‑like ALL and assigns therapy based on the driving genetic alteration: olverembatinib for ABL‑class fusions and gecacitinib for JAK‑pathway alterations. Both groups receive the targeted agent combined with venetoclax and proceed through a defined sequence of induction, consolidation, intensification, and maintenance chemotherapy, with protocol-specified use of blinatumomab as indicated. The primary endpoint is the rate of flow cytometry MRD‑negative complete remission at three months after induction, and secondary endpoints include NGS MRD rates, overall remission, survival outcomes, relapse, and safety. The study is conducted at the Institute of Hematology & Blood Diseases Hospital in Tianjin and is exploratory to determine whether this targeted combination improves early deep remissions.
Why it matters
Potential benefit: If successful, the approach could increase the number of patients achieving early MRD‑negative remissions and reduce the risk of relapse.
How similar studies have gone: ABL‑directed TKIs improved outcomes in Ph‑positive ALL and emerging work supports targeting drivers in Ph‑like ALL, but combining ABL/JAK inhibitors with venetoclax is exploratory and not yet proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Blood diseases hospital
Tianjin, Tianjin Municipality, China Recruiting
Study contacts
- Study coordinator: Hui Wei, MD
- Email: weihui@ihcams.ac.cn
- Phone: 13132507161
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.