Lenalidomide With or Without Idelalisib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma

Phase 1 Completed 106 enrolled Alliance for Clinical Trials in Oncology Biologics, Inc. · collab Celgene Corporation · collab Gilead Sciences · collab National Cancer Institute (NCI) · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This Phase I/II trial studies the safety and effectiveness of lenalidomide with or without idelalisib. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Idelalisib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. It is not yet known whether lenalidomide is more effective with or without idelalisib in treating mantle cell lymphoma.

Timeline

Start: 2013-10-17
Primary completion: 2014-09-30
Completion: 2017-05-01

Outcome

Missed primary endpoint

paper The primary endpoint of safety and tolerability was not met. PMID 28314699 ↗

Publications

Smith SM, Pitcher BN, Jung SH, Bartlett NL, Wagner-Johnston N, Park SI, Richards KL, Cashen AF, Jaslowski A, Smith SE, Cheson BD, Hsi E, Leonard JP. Safety and tolerability of idelalisib, lenalidomide, and rituximab in relapsed and refractory lymphoma: the Alliance for Clinical Trials in Oncology A051201 and A051202 phase 1 trials. Lancet Haematol. 2017 Apr;4(4):e176-e182. doi: 10.1016/S2352-3026(17)30028-5. Epub 2017 Mar 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Idelalisib	Small molecule	150 mg	Oral
Subject	Lenalidomide	Other / unclassified	15 mg	Oral
Subject	Lenalidomide	Other / unclassified	20 mg	Oral
Subject	Lenalidomide	Other / unclassified	25 mg	Oral