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Completed Phase 3 Interventional Results available

Fludarabine, Cyclophosphamide, and Rituximab Versus Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-Cell Chronic Lymphocytic Leukemia Patients

ClinicalTrials.gov ID: NCT00254163

Public ClinicalTrials.gov record NCT00254163. 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 Sep 20, 2026, 7:57 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 Prospective, Randomized, Open Label, Phase III Trial of Fludarabine, Cyclophosphamide, and Rituximab vs. Pentostatin, Cyclophosphamide, and Rituximab in Previously Untreated or Treated B-cell Chronic Lymphocytic Leukemia

Brief summary

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

The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.

Study identification

NCT ID
NCT00254163
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
US Oncology Research
Industry
Enrollment
184 participants

Conditions and interventions

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
Nov 30, 2003
Primary completion
Aug 31, 2011
Completion
Aug 31, 2011
Last update posted
Nov 2, 2016

2003 – 2011

United States locations

U.S. sites
11
U.S. states
9
U.S. cities
11
Facility City State ZIP Site status
Cancer Centers of Florida, P.A. Ocoee Florida 34761
Hope Center Terre Haute Indiana 47802
Alliance Hematology Oncology PA Westminster Maryland 21157
St Joseph Oncology, Inc Saint Joseph Missouri 64507
New York Oncology Hematology, PC Albany New York 12208
Northwestern Carolina Oncology Hemato Hickory North Carolina 28602
Medical Oncology Associates Kingston Pennsylvania 18704
South Texas Cancer Center-McAllen McAllen Texas 78503
Texas Oncology Cancer Center-Sugar Land Sugar Land Texas 77479
Cancer Care Northwest-South Spokane Washington 99202
Yakima Valley Mem Hosp/North Star Lodge Yakima Washington 98902

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 NCT00254163, 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 Nov 2, 2016 · Synced Sep 20, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00254163 live on ClinicalTrials.gov.

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