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

NCT00536341 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2017-01-16

Study results available
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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.

Conditions

Interventions

DRUG

lenalidomide

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

DRUG

Rituximab

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

DRUG

Fludarabine

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

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Genentech, Inc.

    collaborator INDUSTRY

  • SCRI Development Innovations, LLC

    lead OTHER

Principal Investigators

  • Ian W. Flinn, M.D. · SCRI Development Innovations, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2013-04-30
Completion
2016-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00536341 on ClinicalTrials.gov