drugset
drugset / Trial / NCT04914676

Accelerated Dose Schedule of Cytarabine Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML) in Complete Remission

NCT04914676 ↗

Phase 2 Terminated 5 enrolled University of Florida
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This phase 2, open label, non-randomized study will evaluate the safety of administering high dose cytarabine (HiDAC) consolidation therapy on days 1-3 of each cycle, as compared to standard administration on days 1, 3, and 5 of each cycle, in patients 61 years and older with de novo acute myeloid leukemia (AML).

Timeline

Start
2022-03-08
Primary completion
2024-01-12
Completion
2024-08-26

Outcome

Outcome not reported

Stopped (Enrollment): “PI decision to close study early due to limited data due to accrual goal not being met”

Drugs

EvaluationDrugModalityDoseRoute
Subject Cytarabine Small molecule 1000 mg/m2 Intravenous

Indications

acute myeloid leukemia