CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
rituximab +1 morebiological
Likely dose
Lenalidomide oral dose not specified in trial recordAI-extracted
Key inclusion· 6
  • Diagnosis of chronic lymphocytic leukemia (CLL) by flow cytometry
  • Relapsed or refractory disease
  • Measurable disease: absolute lymphocyte count ≥5,000/mm³ or measurable lymphadenopathy/organomegaly
  • At least 1 prior therapy for CLL
Key exclusion· 7
  • Prior lenalidomide (CC-5013) therapy
  • Known hypersensitivity to thalidomide
  • Erythema nodosum with desquamating rash after prior thalidomide or similar drug
  • Known anaphylaxis or IgE-mediated hypersensitivity to murine proteins

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

Search/NCT00096044
NCT00096044Phase 2Completed

CC-5013 Alone or in Combination With Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Roswell Park Cancer Institute·interventional·Posted Nov 9, 2004·Updated Jul 11, 2017

In Brief

A Phase 2 clinical trial evaluating rituximab and lenalidomide for Leukemia. Completed, enrolled 45 participants across 1 site.

Detailed Summary

RATIONALE: Biological therapies such as lenalidomide use different ways to stimulate the immune system and stop cancer cells from growing. Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining lenalidomide with rituximab may kill more cancer cells. PURPOSE: This phase II trial is studying the how well giving lenalidomide with or without rituximab works in treating patients with relapsed or refractory chronic lymphocytic leukemia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia
CountriesUnited States
CollaboratorsCelgene

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2004
Enrollment StartMar 1, 2004
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 11.3 yearsPosted 21.6 years ago

Interventions

rituximabbiological

IV

lenalidomidedrug

Oral