NCT01644799

Lenalidomide and Idelalisib in Treating Patients With Recurrent Follicular Lymphoma

A Phase I Trial of Lenalidomide and Idelalisib in Recurrent Follicular Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Biologic 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. This phase I trial studies the side effects and the best dose of lenalidomide when giving together with idelalisib in treating patients with recurrent follicular lymphoma.

Detailed description

OUTLINE: This is a multicenter, dose-escalation study of lenalidomide. Patients receive lenalidomide orally (PO) on days 1-21 and idelalisib twice daily (BID) on days 1-28. Treatment with lenalidomide and idelalisib repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. The primary and secondary objectives of the study include the following: Primary Objective: * To determine the maximum-tolerated dose (MTD) of lenalidomide when combined with idelalisib in patients with recurrent follicular non-Hodgkin lymphoma (NHL). Secondary Objectives: * To determine the toxicity profile of lenalidomide and idelalisib therapy in patients with recurrent follicular NHL * To estimate the efficacy (overall response rate \[ORR\], complete response rate \[CRR\], and progression-free survival \[PFS\]) of lenalidomide and idelalisib in patients with recurrent follicular NHL in a preliminary fashion (using a small extension cohort) * To assess whether the therapeutic effects of the lenalidomide and idelalisib combination are sufficiently promising to warrant evaluation in a subsequent (phase II/III) randomized trial After completion of study treatment, patients are followed at 2, 4, 6, 9, 12, 15, 18, and 24 months and then annually. Patients are followed once every year for a maximum of 10 years from study entry.

Conditions

• Recurrent Follicular Lymphoma

Interventions

Type	Name	Description
DRUG	idelalisib	oral
DRUG	lenalidomide	oral

Timeline

• Start date: 2013-07-01
• Primary completion: 2014-08-01
• Completion: 2017-05-01
• First posted: 2012-07-19
• Last updated: 2018-01-30

Locations

6 sites across 1 country: United States