ABL‑ or JAK‑targeted drugs 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

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

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 92 (estimated)
• Ages: 14 Years to 60 Years
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (Academic / other)
• Drugs / interventions: olverembatinib, Gecacitinib, chemotherapy
• Locations: 1 site (Tianjin, Tianjin Municipality)
• Trial ID: NCT07454226 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Tianjin, Tianjin Municipality

• Blood diseases hospital — Tianjin, Tianjin Municipality, China (Recruiting)

Study contacts

• Study coordinator: Hui Wei, MD

Conditions Ph-Like; Acute Lymphoblastic Leukemia