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Chemotherapy With Targeted-Immunotherapy for Newly Diagnosed Ph+ ALL

RecruitingNAAges 14 Years - anyAllInstitute of Hematology & Blood Diseases Hospital…
NCT07493161 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is an open-label, prospective clinical cohort study evaluating the efficacy and safety of reduced-intensity chemotherapy combined with targeted therapy and immunotherapy in adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The study consists of two integrated parts. The first part is a randomized controlled comparison to investigate the role of venetoclax, a BCL2 inhibitor, when added to a backbone of olverembatinib (a third-generation TKI) and reduced-intensity chemotherapy (VPVO regimen) during the first three cycles of induction/consolidation therapy. The second part is a single-arm exploration of inotuzumab ozogamicin (InO) combined with TKI and chemotherapy as a consolidation strategy for patients who complete the 90-day primary endpoint assessment but do not receive blinatumomab, offering an alternative to blinatumomab

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📋 Eligibility rules (as published)
Inclusion Criteria: * Newly diagnosed ALL with t(9;22)(q34;q11) or BCR::ABL1 positivity (by PCR or FISH). * Age ≥ 14 years. * ECOG performance status ≤ 2. * Adequate organ function: Total bilirubin \<1.5x ULN; AST/ALT ≤2.5x ULN; Serum creatinine \<2x ULN; Cardiac enzymes \<2x ULN; Serum amylase ≤1.5x ULN; Left ventricular ejection fraction (LVEF) \>45%. * Male and female patients of childbearing potential must agree to use effective contraception. * Signed informed consent. Exclusion Criteria: * Diagnosis of chronic myeloid leukemia in chronic, accelerated, or blast phase. * Prior systemic anti-leukemic therapy for ALL (except corticosteroids or hydroxyurea for cytoreduction prior to enrollment). * Myocardial infarction within 12 months prior to enrollment; uncontrolled/unstable angina, congestive heart failure, uncontrolled hypertension or arrhythmia. * Uncontrolled active severe infection. * Active psychiatric illness that may hinder treatment completion or informed consent. * Any other condition deemed unsuitable for the study by the investigator.
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What it tests

  • Olverembatinib
  • Venetoclax
  • Blinatumomab
  • Chemotherapy Backbone Regimens
  • Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)
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Where

1 site
Blood Diseases Hospital
Tianjin, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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