drugset / Trial / NCT01829568

Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma

NCT01829568

Phase 1 Active not recruiting 33 enrolled National Cancer Institute (NCI) Celgene Corporation · collab
NaSingle-groupOpen-labelTreatment

Summary

This phase I trial studies the side effects and best dose of lenalidomide and ibrutinib when given together with rituximab in treating patients with previously untreated stage II-IV follicular lymphoma. Lenalidomide may stimulate the immune system in different ways and stop cancer cells from growing. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving lenalidomide and ibrutinib together with rituximab may work well in treating follicular lymphoma.

Timeline

Start
2013-06-26
Primary completion
2015-05-11
Completion
2027-06-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ibrutinib Small molecule 420 mg Oral
Subject Ibrutinib Small molecule 560 mg Oral
Subject Lenalidomide Other / unclassified 15 mg Oral
Subject Lenalidomide Other / unclassified 20 mg Oral
Background Rituximab Monoclonal antibody 375 mg/m2 Intravenous