A Phase I Trial of Lenalidomide, Rituximab and Idelalisib in Recurrent Follicular Lymphoma
This is a multicenter, dose-escalation study of lenalidomide.
Patients receive lenalidomide orally (PO) on days 1-21; rituximab intravenously (IV) on days
8, 15, and 22 of course 1 and on day 1 of course 2; 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:
- To determine the maximum-tolerated dose (MTD) of lenalidomide when combined with
rituximab and idelalisib in patients with recurrent follicular non-Hodgkin lymphoma
- To determine the toxicity profile of lenalidomide, rituximab, and idelalisib therapy in
patients with recurrent follicular NHL.
- To estimate the efficacy (overall response [OR] rate, complete response [CR] rate, and
progression-free survival [PFS]) of lenalidomide, rituximab, and idelalisib in patients
with recurrent follicular NHL in a preliminary fashion (using a small extension
- To assess whether the therapeutic effects of the lenalidomide, rituximab, and
idelalisib combination are sufficiently promising to warrant evaluation in a subsequent
(phase II/III) randomized trial (in comparison to the two-drug regimen of lenalidomide
plus rituximab, or another standard regimen).
After completion of study treatment, patients are followed up at 2, 4, 6, 9, 12, 15, 18, and
24 months and then yearly for 10 years.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Up to 13 months
John P. Leonard, MD
Weill Medical College of Cornell University
United States: Food and Drug Administration