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A Phase I Trial Using Cyclophosphamide, Rituximab and Revlimid (CR2) for the Treatment of Relapsed/Refractory B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Small Lymphocytic Lymphoma (SLL)

NCT01005979 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2014-08-13

No results posted yet for this study

Summary

The purpose of this study is to determine the maximum tolerated dose (MTD), safety and toxicity when cyclophosphamide, rituximab and lenalidomide (Revlimid) are combined for the treatment of relapsed/refractory of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).

Conditions

Interventions

DRUG

Lenalidomide, Rituximab, and Cyclophosphamide

COHORT 1: Cyclophosphamide 250 mg/m2 day 1, 2 and 3, Rituximab 500 mg/m2 i.v. day 1, Lenalidomide 2.5 mg/day starting day 8-28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles COHORT 2: Cyclophosphamide 250mg/m2 day 1, 2 and 3. Rituximab 500 mg.m2 i.v. daY Lenalidomide 5 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles COHORT 3: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 10 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles COHORT 4: Cyclophosphamide 250mg/m2 day 1, 2 and 3, Rituximab 500 mg.m2 i.v. day 1, Lenalidomide 15 mg/day starting day 8 -28 of Cycle 1 and then daily on Days 1-28 of subsequent cycles Patients will receive a total of 6-8 cycles.

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Emory University

    lead OTHER

Principal Investigators

  • Rajni Sinha, MD · Emory University Winship 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
2010-07-31
Primary Completion
2012-10-31

Countries

  • United States

Study Locations

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Entities

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 NCT01005979 on ClinicalTrials.gov