Trial of High Dose Lenalidomide in Patients With MDS and AML With Trilineage Dysplasia

Phase 2 Terminated 32 enrolled Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Non-randomizedSingle-groupOpen-labelTreatment

Summary

This is a phase II study of lenalidomide in patients with myelodysplastic syndrome (MDS) and with acute myeloid leukemia (AML) with trilineage dysplasia. Patients will receive two cycles of lenalidomide. Patients who respond may given additional cycles of lenalidomide until disease progression.

Timeline

Start: 2009-07
Primary completion: 2014-05
Completion: 2014-05

Outcome

Outcome not reported

Stopped: “Lack of efficacy”

Publications

Results Zeidan AM, Smith BD, Carraway HE, Gojo I, DeZern A, Gore SD. A phase 2 trial of high dose lenalidomide in patients with relapsed/refractory higher-risk myelodysplastic syndromes and acute myeloid leukaemia with trilineage dysplasia. Br J Haematol. 2017 Jan;176(2):241-247. doi: 10.1111/bjh.14407. Epub 2016 Oct 28.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Lenalidomide	Other / unclassified	50 mg	Oral