drugset / Trial / NCT07642453

VA-CAG Two-Week vs. Three-Week Regimen for Induction Remission in Newly Diagnosed Acute Myeloid Leukemia.

NCT07642453

Phase 2 Not yet recruiting 110 enrolled Hematology department of the 920th hospital
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Objective: This clinical trial aims to compare the efficacy and safety of the VA-CAG regimen administered as a two-week schedule versus a three-week schedule for induction remission in acute myeloid leukemia (AML). Key Research Questions: 1. Is the efficacy of the two-week VA-CAG regimen equivalent to that of the three-week regimen in inducing remission in AML? 2. Does the two-week VA-CAG regimen reduce treatment-related adverse events compared to the three-week regimen? Methods: Researchers will compare the efficacy and safety of the two-week VA-CAG regimen with the three-week regimen for induction remission in AML. Study participants will be randomly assigned to receive standard treatment with either the two-week or three-week VA-CAG regimen. Patients are required to attend monthly follow-up visits for a total of one year. At each follow-up, the following assessments will be performed: complete blood count, liver and kidney function tests, bone marrow aspiration, flow cytometric measurement of minimal residual disease (MRD), and/or fusion gene analysis, along with monitoring of other efficacy endpoints and adverse reactions.

Timeline

Start
2026-06-01
Primary completion
2028-06-01
Completion
2028-06-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Venetoclax Small molecule 400 mg Oral
Background Arubicin Unknown 12 mg/m2 Intravenous
Background Arubicin Unknown 14 mg/m2 Intravenous
Background Azacitidine Other / unclassified 75 mg/m2 Subcutaneous
Background Cytarabine Small molecule 10 mg/m2 Subcutaneous