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Protocol for the Treatment of Patients With Previously Untreated Chronic Lymphocytic Leukemia

NCT00280241 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2016-02-04

Study results available
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Summary

This research study will look at the effects (good or bad) of administering cyclophosphamide, fludarabine, and rituximab. Clinical studies with combination therapy have shown higher response rates than using single drugs, and this study will evaluate the side effects and effectiveness of this combination.

Conditions

Interventions

DRUG

Fludarabine

Fludarabine is usually administered by IV infusion over 30 minutes or longer.

DRUG

Cyclophosphamide

The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.

DRUG

Rituximab

First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Biogen

    collaborator INDUSTRY

  • University of Pittsburgh

    lead OTHER

Principal Investigators

  • Micahel Boyiadzis, MD · University of Pittsburgh Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2008-02-29
Completion
2013-01-31

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 NCT00280241 on ClinicalTrials.gov