Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL)
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|ClinicalTrials.gov Identifier: NCT03232307|
Recruitment Status : Withdrawn (Sponsor does not wish to proceed)
First Posted : July 27, 2017
Last Update Posted : May 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Hematopoietic/Lymphoid Cancer Mantle Cell Lymphoma||Drug: Ibrutinib Drug: Rituximab Drug: Lenalidomide Drug: Dexamethasone Sodium Sulfate||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL)|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 2021|
|Estimated Study Completion Date :||July 2021|
Experimental: Ibrutinib + Rituximab + Lenalidomide
Ibrutinib by mouth each day. Lenalidomide by mouth on Days 1-21. Rituximab by vein on Days 1, 8, 15, and 22 of Cycles 1 and 2. After that, Rituximab by vein on Day 1 of Cycles 3-8 and then every other cycle after that (Cycles 10, 12, 14, and so on). Study cycles are 28 days.
Orally at 560 mg daily for 28 days (one cycle) up to Cycle 11. Starting at Cycle 12, a 2 month supply of ibrutinib dispensed every other cycle. After 3 years, patients treated with ibrutinib in continuous cycles until progression of disease or unacceptable toxicity.
375 mg/m^2 intravenous infusion (IV) given on Days 1, 8, 15 and 22 for Cycles 1 and 2. Then, Day 1 of every cycle, for Cycles 3 - 8. Following Cycle 8 Rituximab given on Day 1 of every other cycle for up to 2 years.
Other Name: Rituxan
Orally at 20 mg daily on Days 1 - 21 of each 28 day cycle for up to one year.
Drug: Dexamethasone Sodium Sulfate
Orally 40 mg weekly administered only for the first 2 cycles.
Other Name: Decadron
- Overall Response Rate (ORR) at 4 Months of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) [ Time Frame: 4 months ]Response assessed according to the International Workshop Standardization Response Criteria for Non-Hodgkin's Lymphoma (Cheson, 2014)
- Summary of Adverse Events of Ibrutinib Plus Rituximab and Lenalidomide in Elderly Patients With Newly Diagnosed Mantle Cell Lymphoma (MCL) [ Time Frame: After 1 cycle, 28 days ]Adverse events assessed according to the Common Toxicity Criteria for Adverse Events version 4.03. (CTCAE v4.03)
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): NCT03232307
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Michael Wang, MD, MS||M.D. Anderson Cancer Center|