A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is a multicenter, randomized, controlled phase III clinical trial aimed at comparing the efficacy of two induction chemotherapy regimens-VA (Venetoclax + Azacitidine) and D/IA (Daunorubicin/Idarubicin + Cytarabine)-in elderly patients (aged 60-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Maximum Age: 75
Healthy Volunteers: f
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• Diagnosis of AML according to WHO (2022) or ICC criteria.
• Age ≥60 and ≤75 years.
• ECOG performance status score of 0-2.
• Adequate organ function:
‣ Total bilirubin ≤1.5× upper limit of normal (ULN)
⁃ AST and ALT ≤2.5× ULN
⁃ Serum creatinine \<2× ULN
⁃ Cardiac enzymes \<2× ULN
⁃ Left ventricular ejection fraction (LVEF, by echocardiogram) within normal range Signed informed consent by the patient or legal representative.
Induction Cycle 1:~* Cytarabine: 100 mg/m²/day, days 1-7~* Daunorubicin: 60 mg/m²/day, days 1-3 or~* Idarubicin: 12 mg/m²/day, days 1-3~ • Induction Cycle 2 (if CR/CRi/CRh not achieved after Cycle 1):~* Cyclophosphamide: 350 mg/m²/day, days 2 and 5o Cytarabine: 100 mg/m²/day, days 1-7~* Daunorubicin: 45 mg/m²/day, days 1-2 or~* Idarubicin: 8 mg/m²/day, days 1-2~Consolidation Therapy~• Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles Ara-C 1g/m² Q12h, d1-3 (aged ≥60 and \<70 years) or Ara-C 500mg/m² Q12h d1-3 (aged ≥70 years)~Maintenance Therapy~* Low/Intermediate-Risk Patients:~ 1. DA/IA 2+5 Regimen, 2 cycles Cytarabine: 100 mg/m²/day, days 1-5 Daunorubicin: 30 mg/m²/day, days 1-2 or Idarubicin: 8 mg/m²/day, days 1-2~ 2. VA Regimen, 4 cycles Azacitidine: 75 mg/m²/day, days 1-5 Venetoclax: 400 mg/day, days 1-7, oral~* High-Risk Patients:~VA Regimen, 6 cycles~Allogeneic Transplantation:~Recommended for high-risk patients and those with persistent MRD positivity.
Experimental: VA Regimen
Induction Cycles~* Azacitidine: 75 mg/m²/day, days 1-7~* Venetoclax:~Day 1: 100 mg Day 2: 200 mg Days 3-21: 400 mg/day If bone marrow blasts \>5% on day 21, extend to day 28 with 400 mg/day~• Efficacy will be assessed after 2 cycles. If CR/CRi/CRh is not achieved but the investigator believes continued treatment is beneficial, up to 4 cycles may be administered.~Consolidation Therapy • Intermediate-Dose Cytarabine (ID-Ara-C): 2 cycles Ara-C 1g/m² Q12h, d1-3 (aged ≥60 and \<70 years) or Ara-C 500mg/m² Q12h d1-3 (aged ≥70 years)~Maintenance Therapy~* Low/Intermediate-Risk Patients:~ 1: DA/IA 2+5 Regimen, 2 cycles Cytarabine: 100 mg/m²/day, days 1-5 Daunorubicin: 30 mg/m²/day, days 1-2 or Idarubicin: 8 mg/m²/day, days 1-2~ 2.VA Regimen, 4 cycles Azacitidine: 75 mg/m²/day, days 1-5 Venetoclax: 400 mg/day, days 1-7, oral~* High-Risk Patients:~ * VA Regimen, 6 cycles~Allogeneic Transplantation:~Recommended for high-risk patients and those with persistent MRD positivity.