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VA vs DA for Newly Diagnosed Hig-risk AML

ConditionAcute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18-64
SponsorThe First Affiliated Hospital of Soochow University

About this trial

This is an open-label, multicenter, phase 2b, randomized study aiming to compare the efficacy and safety of venetoclax plus azacytidine Versus daunorubicin plus cytarabine (conventional 7+3 regimen) in adult acute myeloid leukemia (AML) patients with adverse risk featuress. Participants will be 1:1 randomly assigned to the VA and DA groups. Once remission was achieved, consolidated chemotherapy will be performed and allogeneic hematopoietic stem cell transplantation is strongly recommended. After completion of the study intervention, participants will be followed-up every 1 to 2 months for up to 2 years.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Gender: female or male.

Age:18-64 years old.

Patients with newly diagnosed AML according to the WHO 2022 classification.

AML patients with adverse risk features according to the 2022 European Leukemia Net risk stratification.

Disqualifiers

Patients with acute promyeloid leukemia.

AML with central nervous system infiltration.

Patients diagnosed with myeloid sarcoma.

Patients have AML secondary to MDS and previously been treated with hypomethylating agents.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Venetoclax Oral Tablet

    Drug

    VA regimen: azacytidine, 75mg/m2, subcutaneously, on days 1-7; venetoclax, orally, once a day, 100mg, d1; 200mg, d2; 400mg, days 3-28.

  • Daunorubicin

    Drug

    DA regimen: daunorubicin (60mg/m2) on days 1-3, intraveneously injection, and cytarabine (100mg/m2) on days 1-7, intraveneously injection, for 1 cycle.

Treatment groups

116 Participants
are divided into 2 treatment groups
Group A: VA regimenExperimental treatment 1 intervention
Group B: DA regimenActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Composite complete remission (CRc) after one course of induction therapy

Rates of complete remission plus complete remission with incomplete blood cell rates of complete remission or complete remission with incomplete marrow recovery

Time frame
From randomization to the end of the first course of induction therapy (within 28 days)

Secondary outcomes

1

DOR: duration of remission

Time between the first remission and relapse

Time frame
2 years
2

EFS：event-free survival

time from the date of enrollment to treatment failure, relapse, death from any cause or the last follow-up

Time frame
2 years
3

OS: overall survival

time from the date of enrollment to death from any cause or the last follow-up

Time frame
2 years
4

Volume of infused blood products

The volume of infused blood products during the induction treatment.

Time frame
Within 60 days after randomization

Other outcomes

Sponsors and contacts

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

The First Affiliated Hospital of Soochow University

Lead sponsor

Source ClinicalTrials.gov
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