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Completed Phase 3 Interventional

Efficacy/Safety of Frontline Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Lymphocytic Leukemia

ClinicalTrials.gov ID: NCT00046683

Public ClinicalTrials.gov record NCT00046683. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 26, 2026, 10:34 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase III Study to Evaluate the Efficacy and Safety of Front-Line Therapy With Alemtuzumab (Campath, MabCampath) vs Chlorambucil in Patients With Progressive B-Cell Chronic Lymphocytic Leukemia

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

This is a Phase III, open-label, multicenter, randomized, comparative study of Campath versus chlorambucil as front line therapy in patients with progressive B-Cell Lymphocytic Leukemia (B-CLL). Eligible patients must have previously untreated, Rai stage I-IV disease, and be experiencing progression of their B-CLL requiring treatment. Patients who meet all eligibility criteria may be randomized on a 1:1 basis to receive either Campath or chlorambucil. An estimated 284 patients (142 per treatment arm) from approximately 40 or more investigational sites will be randomized to one of the two treatment arms.

Study identification

NCT ID
NCT00046683
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Genzyme, a Sanofi Company
Industry
Enrollment
284 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 2001 (Type not available)
Primary completion
Not listed
Completion
Jun 2006 (Actual)
Last update posted
Jul 28, 2016

2001 – 2006

United States locations

U.S. sites
20
U.S. states
15
U.S. cities
20
Facility City State ZIP Site status
Not listed Tucson Arizona — —
Not listed Little Rock Arkansas — —
Not listed Fort Myers Florida — —
Not listed Tampa Florida — —
Not listed Hines Illinois — —
Not listed Louisville Kentucky — —
Not listed Paducah Kentucky — —
Not listed Lafayette Louisiana — —
Not listed Jackson Mississippi — —
Not listed Tupelo Mississippi — —
Not listed Jefferson City Missouri — —
Not listed Kansas City Missouri — —
Not listed Billings Montana — —
Not listed Omaha Nebraska — —
Not listed New Hyde Park New York — —
Not listed Rochester New York — —
Not listed Durham North Carolina — —
Not listed Sioux Falls South Dakota — —
Not listed San Antonio Texas — —
Not listed Norfolk Virginia — —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00046683, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 28, 2016 · Synced Oct 26, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00046683 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →