A Study Being Conducted at Multiple Locations to Compare Safety and Efficacy of Three Different Regimens; (1) High-Dose Lenalidomide; (2) Lenalidomide + Azacitidine; or (3) Azacitidine in Subjects ≥ 65 Years With Newly-Diagnosed Acute Myeloid Leukemia

Summary

The study aim is to compare safety and efficacy of high-dose lenalidomide regimen, sequential azacitidine and lenalidomide and an azacitidine in persons ≥65 years with newly-diagnosed acute myeloid leukemia (AML).

Timeline

Start

2012-04-27

Primary completion

2015-05-19

Completion

2018-05-15

Outcome

Missed primary endpoint

paper These data do not favor use of continuous high-dose lenalidomide or sequential azacitidine and lenalidomide over the conventional dose and schedule of azacitidine only PMID 29097499 ↗

Publications

• Medeiros BC, McCaul K, Kambhampati S, Pollyea DA, Kumar R, Silverman LR, Kew A, Saini L, Beach CL, Vij R, Wang X, Zhong J, Gale RP. Randomized study of continuous high-dose lenalidomide, sequential azacitidine and lenalidomide, or azacitidine in persons 65 years and over with newly-diagnosed acute myeloid leukemia. Haematologica. 2018 Jan;103(1):101-106. doi: 10.3324/haematol.2017.172353. Epub 2017 Nov 2.

Drugs

Indications