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Efficacy of Integrated Induction-Consolidation Chemotherapy and Transplantation for Adult Acute Myeloid Leukemia: Multicenter Study

RecruitingPhase 2Ages 14 Years - 65 YearsAllShanxi Bethune Hospital
NCT07108530 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This is a multicenter, single-arm, open-label clinical study designed to evaluate the efficacy and safety of an integrated "induction-consolidation-transplantation" treatment protocol in adult patients with acute myeloid leukemia (AML, excluding M3 subtype). Based on patients' economic conditions, two induction regimens are offered: the IAV regimen (idarubicin + cytarabine + venetoclax) for those with better financial resources, and the DAV regimen (daunorubicin + cytarabine + venetoclax) for those with limited resources. During the consolidation phase, patients receive either the MA regimen (liposomal mitoxantrone + intermediate-dose cytarabine) or intermediate-dose cytarabine monotherapy. Eligible patients proceed directly to allogeneic hematopoietic stem cell transplantation (allo-HSCT), with a FA-BuCy/ATG conditioning regimen and an innovative graft-versus-host disease (GVHD) prophyl

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age: 14 years - 65 years; * Excluding AML-M3 (Acute Promyelocytic Leukemia) patients; * Diagnosis conforming to the Chinese Diagnosis and Treatment Guidelines for Adult Acute Myeloid Leukemia (Non-APL) (2023 Edition), including low-risk, intermediate-risk, and high-risk patients; * Bone marrow morphology indicating hypercellularity or hypocellularity; * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score of 0-2. Exclusion Criteria: * Presence of intracranial hemorrhage; * Pregnancy; * Psychiatric illness or other conditions precluding protocol adherence; * Severe cardiac arrhythmia, abnormal ECG (QTc \>500 ms).
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What it tests

  • Integrated IAV/MA Chemotherapy and Allo-HSCT Protocol for Adult AML
  • First Induction (IAV or DAV Regimen)
  • Consolidation Therapy Options: MA or Intermediate-Dose Cytarabine Regimen
  • Subsequent Treatment Plan for Transplant-Eligible Patients
  • Allogeneic Stem Cell Transplantation Protocol
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Where

1 site
Shanxi Bethune Hospital
Taiyuan, 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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