This phase II trial studies how well ibrutinib plus rituximab and lenalidomide work in treating elderly participants with newly diagnosed mantle cell lymphoma. Ibrutinib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as rituximab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ibrutinib plus rituximab and lenalidomide may work better in treating elderly participants with newly diagnosed mantle cell lymphoma.
Name: Dexamethasone
Description: Given POType: DrugTreatment (ibrutinib, rituximab, lenalidomide, dexamethasone)
Name: Ibrutinib
Description: Given POType: DrugTreatment (ibrutinib, rituximab, lenalidomide, dexamethasone)
Name: Lenalidomide
Description: Given POType: DrugTreatment (ibrutinib, rituximab, lenalidomide, dexamethasone)
Name: Rituximab
Description: Given IVType: BiologicalTreatment (ibrutinib, rituximab, lenalidomide, dexamethasone)
Description: The overall response (complete response + partial response) at four months and toxicity at one month (during course 1) will be monitored simultaneously using the Bayesian approach of Thall, Simon, Estey as extended by Thall and Sung. Independence was assumed between or and toxicity, where toxicity is defined as dose-limiting toxicity (DLT) within cycle 1.
Measure: Overall response rate (ORR) per International Workshop Standardization Response Criteria for non-Hodgkin's lymphoma Time: At 4 months (each cycle is 28 days)Description: Toxicity data by type and severity will be summarized by frequency tables. For the efficacy endpoints, intend-to-treat analysis will be performed. For the toxicity endpoint, per-treated analysis will be performed to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.
Measure: Incidence of adverse events per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 4.03 Time: At 1 month (cycle 1 is 28 days)Description: Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. The distribution of time-to-event endpoints including overall survival and progression free survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
Measure: Overall survival (OS) Time: Up to 4 yearsDescription: Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. The distribution of time-to-event endpoints including overall survival and progression free survival will be estimated using the method of Kaplan and Meier. Comparison of time-to-event endpoints by important subgroups will be made using the log-rank test. Cox proportional hazard regression will be employed for multivariate analysis on time-to-event outcomes.
Measure: Progression-free survival Time: Up to 4 yearsSingle Group Assignment
There is one SNP
- Requires treatment with strong cytochrome P4503A (CYP3A) inhibitors. --- P4503A ---