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 groupsSponsors and collaborators
Source ClinicalTrials.gov