Decitabine for Older or Unfit Patients With Acute Myeloid Leukemia (AML)

Phase 2 Completed 74 enrolled M.D. Anderson Cancer Center

RandomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to compare how well 2 different dosing schedules of decitabine may help control AML. Decitabine is designed to damage the DNA (the genetic material) of cells, which may cause cancer cells to die.

Timeline

Start: 2013-02-05
Primary completion: 2019-05-06
Completion: 2019-05-06

Outcome

Missed primary endpoint

paper The primary endpoint was achieved in similar proportions of patients in the two treatment groups PMID 30545576 ↗

paper p=0·78; difference 3%, -21 to 27 PMID 30545576 ↗

Publications

Short NJ, Kantarjian HM, Loghavi S, Huang X, Qiao W, Borthakur G, Kadia TM, Daver N, Ohanian M, Dinardo CD, Estrov Z, Kanagal-Shamanna R, Maiti A, Benton CB, Bose P, Alvarado Y, Jabbour E, Kornblau SM, Pemmaraju N, Jain N, Gasior Y, Richie MA, Pierce S, Cortes J, Konopleva M, Garcia-Manero G, Ravandi F. Treatment with a 5-day versus a 10-day schedule of decitabine in older patients with newly diagnosed acute myeloid leukaemia: a randomised phase 2 trial. Lancet Haematol. 2019 Jan;6(1):e29-e37. doi: 10.1016/S2352-3026(18)30182-0. Epub 2018 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Decitabine	Small molecule	20 mg/m2	Intravenous