Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients

ConditionAML, Adult
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-75
SponsorInstitute of Hematology & Blood Diseases Hospital, China

About this trial

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 55-75) with acute myeloid leukemia (AML) who are fit for intensive chemotherapy.

Eligibility criteria

Qualifiers

Diagnosis of AML according to WHO (2022) or ICC criteria.

Age ≥55 and ≤75 years.

ECOG performance status score of 0-2.

Total bilirubin ≤1.5× upper limit of normal (ULN)

Disqualifiers

Acute promyelocytic leukemia with PML-RARA fusion gene.

AML with RUNX1-RUNX1T1 or CBFB-MYH11 fusion genes.

AML with BCR-ABL fusion gene.

Relapsed or refractory AML (previously treated with induction chemotherapy, but hydroxyurea is allowed).

Trial design

Treatments tested in this trial

  • Daunorubicin/Idarubicin
  • Cytarabine
  • Azacitidine
  • Venetoclax

Treatment groups

240 Participants
are divided into 2 treatment groups