CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 38 enrolled
Drug / intervention
lenalidomide +1 moredrug
Likely dose
lenalidomide 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01472562
NCT01472562Phase 2Completed
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Phase II Study of Lenalidomide Plus Rituximab in Patients With Previously Untreated Mantle Cell Lymphoma

Weill Medical College of Cornell University·interventional·Posted Nov 16, 2011·Updated Jul 16, 2024

In Brief

A Phase 2 clinical trial evaluating lenalidomide and rituximab for Mantle Cell Lymphoma. Completed, enrolled 38 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMantle Cell Lymphoma
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 16, 2011
Enrollment StartJul 29, 2011
Primary CompletionApr 1, 2014
Study CompletionJul 30, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 14.6 years ago

Interventions

lenalidomidedrug

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.

rituximabbiological

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.