A Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma (PHILEMON)
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|ClinicalTrials.gov Identifier: NCT02460276|
Recruitment Status : Completed
First Posted : June 2, 2015
Last Update Posted : April 24, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Relapsed/Refractory Mantle Cell Lymphoma||Drug: Lenalidomide Drug: Ibrutinib Drug: Rituximab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Ibrutinib, Lenalidomide and Rituximab for Patients With Relapsed/Refractory Mantle Cell Lymphoma|
|Study Start Date :||April 2015|
|Actual Primary Completion Date :||December 31, 2019|
|Actual Study Completion Date :||December 31, 2019|
|Experimental: Lenalidomide, ibrutinib and rituximab.||
- Overall response rate. [ Time Frame: Change of tumor burden meassured from baseline during treatment of maximum 144 weeks. ]Tumor evaluation will be performed with CT/PET for maximum 144 weeks. Discontinuation of evaluation if the patient develops progressive disease.
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): NCT02460276
|Helsinki University Hospital|
|Norwegian Radium Hospital|
|Oslo, Norway, 0424|
|Lund University Hospital|
|Lund, Sweden, 221 85|
|Uppsala Akademiska Hospital|
|Uppsala, Sweden, 751 85|