RecruitingPhase 2Phase 3NCT05404906

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

Randomized, Multicenter, Phase 3 Study of Azacytidine (AZA) + Venetoclax as Maintenance Therapy in Patients With AML in Remissionin Younger Adults With Favorable-risk AML in First Remission After Conventional Chemotherapy


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

124 participants

Start Date

Jun 25, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 YearsMax Age: 64 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether combining two drugs — azacitidine and venetoclax — as maintenance therapy (ongoing low-intensity treatment to prevent relapse) can keep AML in remission in younger adults who have achieved their first complete remission. **You may be eligible if...** - You are between 18 and 64 years old - You have been diagnosed with favorable-risk AML (a specific genetic subtype with a generally good prognosis) - You are in your first complete remission after standard induction and consolidation chemotherapy - You are not immediately going to have a bone marrow transplant **You may NOT be eligible if...** - You have relapsed or refractory AML - You have significant liver or kidney problems - You have an active uncontrolled infection - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAzacitidine

Given SC

DRUGVenetoclax

Given PO

OTHERSupportive care

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


Locations(2)

First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

The First Affiliated Hospital of Soochow University, Jiangsu Institute of Hematology

Suzhou, Jiangsu, China

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NCT05404906


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