Treatment Outcome in Elderly Patients

Phase 3 Completed 330 enrolled University Hospital, Grenoble BGMT · collab French Innovative Leukemia Organisation · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

A multicenter randomized trial evaluating the possible benefit of androgens during post remission therapy in an attempt to improve the outcome of AML in older patients.All patients received the ICL regimen as induction and were randomized to receive, after achieving CR or PR, a maintenance therapy including or not androgens. Patients randomized with androgens additionally received 10 to 20 mg according to body weigh of norethandrolone daily for up to 2 years

Timeline

Start: 2002-06
Primary completion: 2005-04
Completion: 2008-05

Outcome

Met primary endpoint

paper In arms A and B, respectively, 5-year disease-free survival was 31.2% and 16.2% PMID 28129526 ↗

Publications

Pigneux A, Bene MC, Guardiola P, Recher C, Hamel JF, Sauvezie M, Harousseau JL, Tournilhac O, Witz F, Berthou C, Escoffre-Barbe M, Guyotat D, Fegueux N, Himberlin C, Hunault M, Delain M, Lioure B, Jourdan E, Bauduer F, Dreyfus F, Cahn JY, Sotto JJ, Ifrah N. Addition of Androgens Improves Survival in Elderly Patients With Acute Myeloid Leukemia: A GOELAMS Study. J Clin Oncol. 2017 Feb;35(4):387-393. doi: 10.1200/JCO.2016.67.6213. Epub 2016 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	norethandrolone	Small molecule	10 mg	Oral
Subject	norethandrolone	Small molecule	20 mg	Oral
Background	Cytarabine	Small molecule	100 mg/m2	Subcutaneous
Background	Idarubicin	Small molecule	8 mg/m2	—
Background	Lomustine	Small molecule	200 mg/m2	—
Background	MERCAPTOPURINE ANHYDROUS	Small molecule	—	—
Background	Methotrexate	Small molecule	—	—