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โ† Trials
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ABL/JAK Inhibitors With Chemotherapy and Venetoclax for Ph-like ALL

RecruitingNAAges 14 Years - 60 YearsAllInstitute of Hematology & Blood Diseases Hospitalโ€ฆ
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ14 years and โ‰ค60 years, regardless of gender * ECOG performance status score โ‰ค2 * Male and female participants of childbearing potential agree to and adopt effective contraceptive measures * Criteria for major organ function assessment: total bilirubin \<1.5 ร— upper limit of normal (ULN), aspartate aminotransferase (AST) and alanine aminotransferase (ALT) โ‰ค2.5 ร— ULN; serum creatinine \<2 ร— ULN; myocardial enzymes \<2 ร— ULN; serum amylase โ‰ค1.5 ร— 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
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What it tests

  • Olverembatinib
  • Gecacitinib
  • Venetoclax
  • Chemotherapy Regimen
  • Blinatumomab
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Where

1 site
Blood diseases hospital
Tianjin, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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