Phase I Study of Lenalidomide, Rituximab and Ibrutinib in Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL)
This study is for subjects diagnosed with recurrent or relapsed CLL/SLL. The purpose of this study is to test the safety of the combination of the drugs lenalidomide and ibrutinib at different dose levels, in combination with the drug rituximab. We want to find out what effects, good and/or bad, they have on patients with CLL/SLL.
The hypothesis of the study is that it will be safe to give the three drugs in combination and the information learned from this trial will be used to study the 3 drug combination is a larger future trial.
|Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma||Drug: Lenalidomide, Ibrutinib, Rituximab||Phase 1|
|Study Design:||Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Lenalidomide in Combination With Rituximab and Ibrutinib in Relapsed and Refractory CLL and SLL|
- Recommended Phase II dose [ Time Frame: 1year ]The dose at which less than 2 of 6 patients experience a dose limiting toxicity
- Safety [ Time Frame: 2 years ]adverse events, serious adverse events, adverse events leading to discontinuation, deaths
- Antitumor efficacy [ Time Frame: 2 years ]Proportion of patients who achieve stable disease, partial or complete response; progression-free survival defined as duration of time from start of treatment to time of progression or death
|Study Start Date:||April 2014|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
Experimental: Lenalidomide, Ibrutinib, Rituximab
Rituximab on day 1, lenalidomide days 1-21 and ibrutinib continuously for 6 cycles or until disease progression or intolerance to the combination. Single agent ibrutinib will then be continued until disease progression or intolerance.
Drug: Lenalidomide, Ibrutinib, Rituximab
Dose level -2 Ibrutinib 280 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level -1 Ibrutinib 420 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level 1 Ibrutinib 420 mg; Lenalidomide 5 mg; Rituximab 375 mg/m2 Level 2 Ibrutinib 420 mg; Lenalidomide 10 mg; Rituximab 375 mg/m2 Level 3 Ibrutinib 420 mg; Lenalidomide 15 mg; Rituximab 375 mg/m2
Please refer to this study by its ClinicalTrials.gov identifier: NCT02200848
|United States, District of Columbia|
|Georgetown Lombardi Comprehensive Cancer Center|
|Washington, D.C., District of Columbia, United States, 20007|
|Principal Investigator:||Chaitra Ujjani, MD||Georgetown Lombardi Comprehsnive Cancer Center|