CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 64 enrolled
Drug / intervention
lenalidomide +2 moredrug
Likely dose
lenalidomide 2.5 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/NCT00536341
NCT00536341Phase 2Completed
CompareCT.gov

A Phase I/II Study of Fludarabine, Rituximab, and Lenalidomide in Minimally Treated and Untreated Patients With Chronic Lymphocytic Leukemia

SCRI Development Innovations, LLC·interventional·Posted Sep 27, 2007·Updated Jan 16, 2017

In Brief

A Phase 2 clinical trial evaluating lenalidomide, Rituximab, and 1 other intervention for Chronic Lymphocytic Leukemia. Completed, enrolled 64 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Lymphocytic Leukemia
CountriesUnited States
CollaboratorsCelgene Corporation, Genentech, Inc.

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 27, 2007
Enrollment StartJan 1, 2008
Primary CompletionApr 1, 2013
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 18.8 years ago

Interventions

lenalidomidedrug

2.5 mg orally (PO) daily, Days 8-28, Cycle 1; 5.0 mg PO daily, Days 8-28 Cycles 2-6

Rituximabdrug

375 mg/m2 Cycle 1 (split over Day 1 \& Day 2); 500 mg/m2 Day 1 of Cycles 2-6

Fludarabinedrug

25 mg/m2 on Days 1, 2, and 3