Conditions: Mantle Cell Lymphoma
Keywords: mantle cell lymphoma
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 38
Healthy volunteers: no

Brief summary:
This is a phase II, multicenter study to determine the efficacy and safety of first-line lenalidomide plus rituximab therapy in patients with mantle cell lymphoma who have received no prior systemic therapy.

Detailed description:
Induction Phase (week 1 - 48):

* Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
* Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance Phase (week 49 - progression of disease):

* Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
* Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Response Assessment

* Year 1-2: Conventional restaging CT scan (or MRI) with IV contrast every 3 months from cycle 1 day 1 of the study.
* Year 3 onwards: Conventional restaging CT scan (or MRI) with IV contrast every 6 months until progression.

Arms:
arm 1: Induction Phase (week 1 - 48):

* Lenalidomide will be given at 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
* Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance Phase (week 49 - progression of disease):

* Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle.
* Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Interventions: intervention 1: lenalidomide intervention 2: rituximab
Intervention descriptions: intervention 1: Induction phase: 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.

Maintenance phase: Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle. intervention 2: Induction phase: Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.

Maintenance phase: Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52.

Protocol document: