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AZA + Venetoclax as Maintenance Therapy in Younger Adults With AML in First Remission

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

About this trial

This phase III trial is conducted to evaluate if azacitidine in combination with venetoclax as maintenance therapy improves relapse-free survival (RFS) for younger adults with favorable-risk acute myeloid leukemia (AML) who remained in first complete remission (CR1) following intensive consolidation.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of favorable-risk acute myeloid leukemia (AML) according to revised 2017 European LeukemiaNet genetic risk stratification and are not immediate candidates for allogeneic stem cell transplant.

Aged 18-64 years.

Patients who have received remission induction therapy and 3-4 HiDAC or medium-dose cytarabine-based consolidation and are in their first remission.

ECOG performance status of < or = 3.

Disqualifiers

Acute promyeloid leukemia.

Patients with active central nervous system (CNS) leukemia.

Previously diagnosed with myelodysplastic syndrome (MDS) or myeloproliferative neoplasm(MPN) and progressed to AML.

Patients with other progressive malignancies.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Azacitidine

    Drug

    Given SC

  • Venetoclax

    Drug

    Given PO

  • Supportive care

    Other intervention

    Patients will receive disease monitoring and supportive care for any complication.

Treatment groups

124 Participants
are divided into 2 treatment groups
Group A: Treatment (azacytidine+venetoclax)Experimental treatment 3 interventions
Group B: Comparator ( best supportive care)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Relapse-free survival (RFS)

RFS is defined as the number of days from CR/CRi to the date of relapse or the date of death from any cause, whichever comes first.

Time frame
From date of complete remission (CR) or complete remission with incomplete count recovery (CRi), to relapse or death from any cause, up to approximately 3 years

Secondary outcomes

1

Percentage of Participants Who Achieve Minimal Minimal Residual Disease (MRD) Negative Conversion

The MRD conversion rate is defined as the percentage of participants deemed MRD positive (≥ 10\^-3) at study initiation who converted to MRD of \< 10\^-3 in the bone marrow after randomization or initiation of treatment.

Time frame
Measured From Baseline to approximately 3 years
2

Complete remission duration (CRd)

CRd is defined as time from CR/CRi until date of confirmed relapse

Time frame
From date of CR/CRi to approximately 3 years
3

Overall Survival (OS)

OS is defined as the number of days from the date of study treatment to the date of death.

Time frame
Time from treatment to death from any cause, up to approximately 3 years
4

Event free survival (EFS)

EFS is defined as time from the start of study treatment until date of first confirmed relapse, withdrawal from study due to adverse event, or death due to any cause,

Time frame
Time from treatment to relapse，withdrawal from study due to adverse event and death from any cause, up to approximately 3 years

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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