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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
oral
oral
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
University of Chicago
Chicago, Illinois, United States
Washington University School of Medicine
St Louis, Missouri, United States
Weill Medical College of Cornell University
New York, New York, United States
MTD based on the incidence of dose-limiting toxicity (DLT) assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time frame: Up to 13 months
Toxicity profile assessed by NCI CTCAE version 4.0
Time frame: Up to 10 years
OR rate assessed up to 10 years
Time frame: Up to 10 years
CR rate assessed up to 10 years
Time frame: Up to 10 years
PFS assessed up to 10 years
Time frame: Up to 10 years
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University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States