Study of Ibrutinib in Combination With Rituximab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma and Marginal Zone Lymphoma
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|ClinicalTrials.gov Identifier: NCT02532257|
Recruitment Status : Active, not recruiting
First Posted : August 25, 2015
Last Update Posted : June 19, 2019
The goal of this clinical research study is to learn if adding Imbruvica (ibrutinib) to Rituxan (rituximab) and Revlimid (lenalidomide) can help to control previously untreated follicular lymphoma (FL) and marginal zone lymphoma.
This is an investigational study. Ibrutinib is FDA approved and commercially available for the treatment of patients with mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and Waldenstrom's macroglobulinemia. Lenalidomide is FDA approved and commercially available for the treatment of multiple myeloma (MM), mantle cell lymphoma, and myelodysplastic syndrome (MDS). Rituximab is FDA approved and commercially available for the treatment of non-Hodgkin lymphoma (NHL).
It is considered investigational to use ibrutinib, lenalidomide, and rituximab to treat FL and marginal zone lymphoma.
Up to 60 participants will be enrolled in this study. All will take part at MD Anderson.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Follicular Lymphoma (FL)||Drug: Lenalidomide Drug: Rituximab Drug: Ibrutinib||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Phase 2 Study of Ibrutinib in Combination With Rituximab and Lenalidomide in Previously Untreated Subjects With Follicular Lymphoma and Marginal Zone Lymphoma|
|Actual Study Start Date :||April 11, 2016|
|Estimated Primary Completion Date :||April 2020|
|Estimated Study Completion Date :||April 2021|
Experimental: Lenalidomide + Rituximab + Ibrutinib
Participants receive 12 cycles of Lenalidomide, 15 mg daily on Days 1 - 21 of Cycle 1, and 20 mg daily on Days 1 - 21 of Cycles 2 through 12. Cycles are 28 days in length. Participants receive Rituximab, 375 mg/m2 on Days 1, 8, 15, and 22 of Cycle 1, and Day 1 of Cycles 2 through 12. Participants receive Ibrutinib 560 mg daily, starting on Day 1 of Cycle 1 and continued through 12 cycles.
15 mg by mouth on Days 1-21 of Cycle, and 20 mg on Days 1 - 21 of Cycles 2 - 12.
375 mg/m2 by vein on Days 1, 8, 15, and 22 of Cycle 1, and Day 1 of Cycles 2 through 12.
Other Name: Rituxan
560 mg by mouth daily, starting on Day 1 of Cycle 1 and continued through 12 cycles.
- Progression Free Survival (PFS) [ Time Frame: 2 years ]PFS defined as the time from the treatment start date (Cycle 1, Day 1) until the first date of objectively documented progressive disease or date of death from any cause. Response assessed by the investigator based on the 2014 Cheson Lugano criteria.
- Complete Response (CR) [ Time Frame: 120 weeks ]CR determined by the investigator based on the 2014 Cheson Lugano criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02532257
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Loretta Nastoupil, MD||M.D. Anderson Cancer Center|