Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Daunorubicin/Idarubicin

    Drug

    Daunorubicin/Idarubicin is used in Induction Therapy and Maintenance Therapy.

  • Cytarabine

    Drug

    Cytarabine is used in Induction Therapy, Consolidation Therapy and Maintenance Therapy.

  • Azacitidine

    Drug

    Azacitidine is used in VA regimen

  • Venetoclax

    Drug

    Venetoclax is used in VA regimen

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: D/IA (Daunorubicin/Idarubicin + Cytarabine)Active comparator 4 interventions
Group B: VA RegimenExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Overall Survival (OS)

Time from randomization to death from any cause.

Time frame
up to 1 years after completion of enrollment

Secondary outcomes

1

Composite Complete Remission Rate (CR/CRh/CRi)

Proportion of patients achieving CR, CRh, or CRi after induction.

Time frame
Six weeks after induction therapy
2

MRD Negativity Rate

Proportion of patients achieving MRD negativity after induction and overall treatment.

Time frame
up to 1 years after completion of enrollment
3

Relapse-Free Survival (RFS)

Time from achieving CR/CRh/CRi to relapse or death.

Time frame
up to 1 years after completion of enrollment
4

Event-Free Survival (EFS)

Time from randomization to treatment failure, relapse, or death.

Time frame
up to 1 years after completion of enrollment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institute of Hematology & Blood Diseases Hospital, China

Lead sponsor

Source ClinicalTrials.gov
Apply now