CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 97 enrolled
Drug / intervention
rituximab +1 morebiological
Likely dose
Not stated in record
Key inclusion· 7
  • Histologically confirmed follicle center cell lymphoma (WHO grade 1, 2, or 3a)
  • CD20 antigen expression confirmed by institutional flow cytometry or immunohistochemistry
  • Prior rituximab treatment (alone or with chemotherapy)
  • Time to progression ≥6 months from last rituximab dose
Key exclusion· 6
  • CNS involvement by lymphoma
  • HIV infection
  • Active second malignancy (except non-melanoma skin cancers)
  • Recent DVT/PE within 3 months of study entry

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

Search/NCT00238238
NCT00238238Phase 2Completed

A Randomized Phase II Trial of Rituximab Versus Lenalidomide (REVLIMID™, Cc-5013) (IND#73034) Versus Rituximab + Lenalidomide in Recurrent Follicular Non-Hodgkin Lymphoma (NHL) That is Not Rituximab-Refractory

Alliance for Clinical Trials in Oncology·interventional·Posted Oct 13, 2005·Updated Mar 15, 2017

In Brief

A Phase 2 clinical trial evaluating rituximab and lenalidomide for Lymphoma. Completed, enrolled 97 participants across 79 sites.

Detailed Summary

Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. Lenalidomide may also stop the growth of non-Hodgkin's lymphoma by blocking blood flow to the cancer. Giving rituximab together with lenalidomide may kill more cancer cells. This randomized phase II trial is studying how well rituximab and/or lenalidomide work in treating patients with follicular non-Hodgkin's lymphoma that is not refractory to rituximab.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLymphoma
CountriesUnited States

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 13, 2005
Enrollment StartMar 1, 2006
Primary CompletionJun 1, 2012
Study CompletionAug 1, 2015
TodayJul 2, 2026
Enrollment to primary: 6.3 yearsPosted 20.7 years ago

Interventions

rituximabbiological

Given IV

lenalidomidedrug

Given orally