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NCT Number: NCT07454226

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

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.

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Key information

Conditions

Ph-Like Acute Lymphoblastic Leukemia Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

14 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Blood diseases hospital

Tianjin, Tianjin Municipality, 300020, China

Location status: Recruiting

Location contact

Hui Wei

CONTACT

[email protected]

022-23608456

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olverembatinib

Drug

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

Gecacitinib

Drug

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

Venetoclax

Drug

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

Chemotherapy Regimen

Drug

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

Blinatumomab

Drug

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

CAR-T Cell Therapy

Procedure

Optional cellular immunotherapy preceded by fludarabine/cyclophosphamide lymphodepletion.

allogeneic HSCT

Procedure

Stem cell transplantation for eligible patients in first complete remission.

Primary outcomes

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

    Time frame: At 3 months after treatment initiation

Secondary outcomes

  1. Complete response (CR) rate

    Time frame: At completion of induction therapy

  2. Rate of next-generation sequencing-MRD (NGS-MRD) negative complete remission at 3 months post-treatment

    Time frame: At 3 months after start of treatment

  3. Overall survival

    Time frame: Up to 5 years

  4. Disease-free survival

    Time frame: Up to 5 years

  5. Relapse-free survival

    Time frame: Up to 5 years

  6. Cumulative incidence of relapse

    Time frame: Up to 5 years

  7. 60-day mortality rate

    Time frame: At 60 days

Study contacts

Contact information is provided by the study sponsor or research team.

Hui Wei, MD

CONTACT

[email protected]

13132507161

Sponsors and collaborators

Lead sponsor

Institute of Hematology & Blood Diseases Hospital, China

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Mar 6, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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