Clinical Trial: Lenalidomide Plus Rituxan for Untreated Mantle Cell Lymphoma

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Study of Lenalidomide Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

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 Summary:

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.

Sponsor: Weill Medical College of Cornell University

Current Primary Outcome: Overall Response Rate [ Time Frame: 30 months ]

The primary endpoint of overall response rate will be estimated and a 95% confidence interval will be estimated via binomial proportions.


Original Primary Outcome: To evaluate the efficacy of lenalidomide and rituximab based on Change in tumor burden from baseline (Cheson criteria) [ Time Frame: baseline, every 3 months for 3 years, then every 6 months for 2 years ]

subjects will have CT scans at baseline and every 3 months - Cheson criteria will be used to determine response to treatment


Current Secondary Outcome: 2-year Progression-free Survival [ Time Frame: 30 months ]

PFS will be defined as the time from first treatment day until objective or symptomatic progression or death.


Original Secondary Outcome: To evaluate the safety of lenalidomide plus rituxibmab based on adverse event assessments [ Time Frame: Day 1 of each cycle of study treatment (every 28 days) for up to 5 years ]

Adverse events will be evaluated using the CTCAE version 4.0.


Information By: Weill Medical College of Cornell University

Dates:
Date Received: March 24, 2011
Date Started: June 2011
Date Completion: October 2020
Last Updated: February 23, 2017
Last Verified: February 2017