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Dose Escalation Study of Revlimid With Fludarabine-Rituximab for CLL/SLL

NCT00543114 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2016-05-27

No results posted yet for this study

Summary

The purpose of this study is to determine the safety of lenalidomide (revlimid) in combination with fludarabine and rituximab and to determine the highest dose of lenalidomide that can safely be given in that combination. Lenalidomide is a drug that alters the immune system and may also interfere with the the development of tiny blood vessels that help support tumor growth. Lenalidomide is approved by the FDA for the treatment of two different blood cancers called myelodysplastic syndrome and multiple myeloma. Lenalidomide has also been studied in subjects with relapsed CLL. In this research study we are adding lenalidomide to a well-established initial therapy for CLL/SLL.

Conditions

Interventions

DRUG

Lenalidomide

Dose level will depend upon time the participant enrolls on the study: Given orally once a day for 3 weeks followed by a one week rest period

DRUG

Fludarabine

Dose level will vary depending upon when participant enters the trial: Given intravenously for 3-5 days

DRUG

Rituximab

Given intravenously on Day 1 of each 28 day cycle

Sponsors & Collaborators

Principal Investigators

  • Jennifer R. Brown, MD, PhD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2009-06-30
Completion
2012-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00543114 on ClinicalTrials.gov