RecruitingNot ApplicableNCT07454226

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


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

92 participants

Start Date

May 30, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 14 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Allogeneic HSCT, a drug called Blinatumomab, and others for people with acute lymphoblastic leukemia and ph-like. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOlverembatinib

Third-generation TKI targeting ABL class fusions. 40 mg every other day, continuous throughout all phases except during HD-MTX.

DRUGGecacitinib

JAK1/2 inhibitor targeting JAK pathway alterations. 100 mg twice daily during CAMVT consolidation and maintenance.

DRUGVenetoclax

BCL-2 inhibitor. Escalating doses (100→200→400 mg) during induction; 400 mg during maintenance VP cycles.

DRUGChemotherapy Regimen

Multi-agent chemotherapy including vincristine, prednisone, daunorubicin, cyclophosphamide, pegaspargase, cytarabine, 6-MP, MTX, and dexamethasone per protocol phases.

DRUGBlinatumomab

Optional CD19-directed BiTE antibody. 28-day continuous infusions alternating with chemotherapy.

PROCEDURECAR-T Cell Therapy

Optional cellular immunotherapy preceded by fludarabine/cyclophosphamide lymphodepletion.

PROCEDUREAllogeneic HSCT

Stem cell transplantation for eligible patients in first complete remission.


Locations(1)

Blood diseases hospital

Tianjin, Tianjin Municipality, China

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NCT07454226


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