RecruitingPhase 3NCT07132684

Comparison of VA and D/IA Induction Regimens in Elderly Fit Acute Myeloid Leukemia Patients

A Multicenter, Randomized, Controlled Clinical Trial Comparing VA and D/IA Induction Regimens in Elderly Patients With Acute Myeloid Leukemia Suitable for Intensive Chemotherapy


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

240 participants

Start Date

Aug 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 55 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different chemotherapy regimens — venetoclax + azacitidine (VA) versus decitabine + idarubicin + cytarabine (D/IA) — as initial treatments for older adults with acute myeloid leukemia (AML), a fast-moving blood cancer. **You may be eligible if...** - You are 55–75 years old - You have been newly diagnosed with AML according to current medical guidelines - You are in reasonably good functional health (able to do some daily activities) - Your heart, liver, and kidneys are functioning well enough for treatment **You may NOT be eligible if...** - You have a specific subtype of AML called acute promyelocytic leukemia (APL) or AML with certain genetic markers (RUNX1-RUNX1T1, CBFB-MYH11, or BCR-ABL) - Your AML has come back after previous induction chemotherapy - You have other conditions that would make these chemotherapy drugs unsafe 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

DRUGDaunorubicin/Idarubicin

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

DRUGCytarabine

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

DRUGAzacitidine

Azacitidine is used in VA regimen

DRUGVenetoclax

Venetoclax is used in VA regimen


Locations(1)

Blood Diseases Hospital

Tianjin, China

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NCT07132684


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