NCT07454226

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

RecruitingNA

Study 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.

At a glance

Conditions: Ph-Like, Acute Lymphoblastic Leukemia
Interventions: Olverembatinib, Gecacitinib, Venetoclax, Chemotherapy Regimen, Blinatumomab, CAR-T Cell Therapy, Allogeneic HSCT
Lead sponsor: Institute of Hematology & Blood Diseases Hospital, China
Target enrollment: 92 participants
Age: 14 Years – 60 Years
Sex: ALL
Locations: Blood diseases hospital
Registry: View on ClinicalTrials.gov ↗

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