drugset / Trial / NCT00536341

Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)

NCT00536341

NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial will combine fludarabine, rituximab, and lenalidomide in untreated or minimally treated (Phase I only) CLL patients, employing fixed doses of fludarabine and rituximab, using a schedule similar to that examined by investigators at MD Anderson (J Clin Oncol 23(18):4079-88, 2005). Given that the optimal dose and schedule is not currently known, this trial will perform a phase I component followed by a phase II examination to further explore this regimen's activity.

Timeline

Start
2008-01
Primary completion
2013-04
Completion
2016-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Fludarabine Small molecule 25 mg/m2
Subject Lenalidomide Other / unclassified 5 mg Oral
Subject Rituximab Monoclonal antibody 500 mg/m2