Lenalidomide, Rituximab, and Idelalisib in Treating Patients With Recurrent Follicular Lymphoma
Biologic therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. 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 rituximab and idelalisib in treating patients with recurrent follicular lymphoma.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Trial of Lenalidomide, Rituximab and Idelalisib in Recurrent Follicular Lymphoma|
- 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 ] [ Designated as safety issue: Yes ]
- Toxicity profile assessed by NCI CTCAE version 4.0 [ Time Frame: Up to 10 years ] [ Designated as safety issue: Yes ]
- OR rate assessed up to 10 years [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- CR rate assessed up to 10 years [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
- PFS assessed up to 10 years [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Experimental: lenalidomide, rituximab and idelalisib
Lenalidomide will be administered orally on days 1-20 followed by 7 days of rest, every 28 days. A treatment cycle will be considered 28 days in length. In the absence of intolerable toxicity or disease progression, lenalidomide will be given for a total of 12 cycles.
Dosing is fixed in all cohorts receiving idelalisib at 150 mg orally (twice daily) for 12 cycles, with the exception of dose modifications for toxicity.
Rituximab 375 mg/m2 will be administered by intravenous (IV) infusion during cycle 1 on days 8,15, 22, and on day 1 of cycle 2 (a total of four doses) for all dose level cohorts.
Rituximab 375 mg/m2 will be administered by intravenous (IV) infusion.Drug: idelalisib
Idelalisib will be administered orally (twice daily) at 150 mg.Drug: lenalidomide
Lenalidomide will be administered orally.
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 (NHL).
- 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 cohort).
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01644799
|United States, District of Columbia|
|MedStar Georgetown University Hospital||Recruiting|
|Washington, District of Columbia, United States, 20007|
|Contact: Bruce Cheson 202-444-7932|
|United States, Illinois|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Sonali Smith 773-702-9251|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|St. Louis, Missouri, United States, 63110|
|Contact: Nancy Bartlett, M.D. 314-362-5654|
|United States, New York|
|Weill Medical College of Cornell University||Recruiting|
|New York, New York, United States, 10065|
|Contact: John Leonard 646-962-2068|
|United States, North Carolina|
|University of North Carolina at Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599|
|Contact: Steven Park, M.D. 919-966-4432 ext 236|
|United States, Ohio|
|Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Beth Christian, M.D. 614-293-3196|
|Principal Investigator:||John P. Leonard, MD||Weill Medical College of Cornell University|