Recurrent Follicular Lymphoma Clinical Trial
Official title:
A Phase I Trial of Lenalidomide and Idelalisib in Recurrent Follicular Lymphoma
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.
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