Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT01472562
Phase
PHASE2
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • lenalidomide — DRUG
    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.
  • rituximab — BIOLOGICAL
    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.

Study Details

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.

Key Dates

Start date
Jul 29, 2011
Status verified
Jul 2024
Primary completion
Apr 30, 2014
Completion
Jul 30, 2023

Study Design

Enrollment
38 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: all patients
    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.

Primary Outcome Measure

Overall Response Rate [ Time Frame: 30 months ]

Locations (4)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612-
University of ChicagoChicagoIllinois60637-
Weill Cornell Medical CollegeNew YorkNew York10065-
University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Tampa, FL

By research site
Moffitt Cancer Center· Tampa, FLUniversity of Chicago· Chicago, ILWeill Cornell Medical College· New York, NYUniversity of Pennsylvania· Philadelphia, PA

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