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A Phase II Trial of Alemtuzumab and Rituximab in Patients With Previously Untreated CLL

NCT00858117 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-11-06

Study results available
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Summary

RATIONALE: Monoclonal antibodies, such as alemtuzumab and rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving alemtuzumab together with rituximab may kill more cancer cells.

PURPOSE: This phase II trial is studying the side effects of giving alemtuzumab together with rituximab and to see how well it works in treating patients with previously untreated B-cell chronic lymphocytic leukemia.

Conditions

Interventions

BIOLOGICAL

Alemtuzumab

Alemtuzumab administered subcutaneously 30mg per day, 3 days per week for 18 weeks

BIOLOGICAL

Rituximab

Rituximab administered intravenously at 375mg/m2 every 2 weeks for 18 weeks

Sponsors & Collaborators

Principal Investigators

  • Olga Frankfurt, MD · Northwestern University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-26
Primary Completion
2010-03-17
Completion
2013-01-24

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 NCT00858117 on ClinicalTrials.gov