A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma
- Sponsor
- Lund University Hospital
- Study ID
- NCT02460276
- Phase
- PHASE2
- Status
- Completed
Conditions
- Relapsed/Refractory Mantle Cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
Study Details
In this trial, patients with mantle cell lymphoma will be included, treatment with lenalidomide, rituximab and ibrutinib will be administered in an induction phase for up to 12 cycles, cycle length 28 days. Patients with complete remission, partial response or stable disease will enter a maintenance phase with treatment with ibrutinib and rituximab until progression of disease. The primary objective is to evaluate overall response rate, based on PET and CT.
Key Dates
- Start date
- Apr 30, 2015
- Status verified
- Apr 2020
- Primary completion
- Dec 31, 2019
- Completion
- Dec 31, 2019
Study Design
- Enrollment
- 50 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Lenalidomide, ibrutinib and rituximab.
Primary Outcome Measure
Overall response rate. [ Time Frame: Change of tumor burden meassured from baseline during treatment of maximum 144 weeks. ]