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Alemtuzumab + Rituximab Consolidation in CLL

NCT00771602 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2015-06-23

Study results available
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Summary

The goal of this clinical research study is to find out how well Campath (alemtuzumab), Rituxan (rituximab), or a combination of the 2 drugs may control Chronic Lymphocytic Leukemia (CLL) that is left after chemotherapy. The safety of these drugs will also be studied.

Conditions

Interventions

DRUG

Rituximab

375 mg/m\^2 by standard IV (intravenous) infusion on days 1, 8, 15, and 22 of weeks 1-4.

DRUG

Alemtuzumab

Dose escalation of 3, 10 and 30 mg subcutaneously (SQ) during week 1, followed by dose of 30 mg subcutaneously three times weekly (e.g. Monday-Wednesday - Friday) starting on week 2 for a total of 12 weeks (2-13).

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Stefan Faderl, M.D. · M.D. Anderson Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2010-12-31
Completion
2010-12-31

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 NCT00771602 on ClinicalTrials.gov