Fludarabine and Monoclonal Antibody Therapy in Treating Patients With Untreated B-cell Chronic Lymphocytic Leukemia
Public ClinicalTrials.gov record NCT00003248. 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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Randomized Phase II Study of Concurrent Fludarabine + Chimeric Anti-CD20 Monoclonal Antibody IDEC-C2B8 (Rituximab) [NSC# 687451] Induction Followed By Rituximab Consolidation In Untreated Patients With B-Cell Chronic Lymphocytic Leukemia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more cancer cells. PURPOSE: Randomized phase II trial to compare the effectiveness of fludarabine given with or without monoclonal antibody therapy followed by monoclonal antibody therapy alone in treating patients who have untreated B-cell chronic lymphocytic leukemia.
Study identification
- NCT ID
- NCT00003248
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 104 participants
Conditions and interventions
Conditions
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
- Feb 28, 1998
- Primary completion
- Mar 31, 2003
- Completion
- May 31, 2010
- Last update posted
- Jul 19, 2016
1998 – 2010
United States locations
- U.S. sites
- 34
- U.S. states
- 19
- U.S. cities
- 27
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of California San Diego Cancer Center | La Jolla | California | 92093-0658 | — |
| UCSF Cancer Center and Cancer Research Institute | San Francisco | California | 94115-0128 | — |
| CCOP - Christiana Care Health Services | Wilmington | Delaware | 19899 | — |
| Walter Reed Army Medical Center | Washington D.C. | District of Columbia | 20307-5000 | — |
| CCOP - Mount Sinai Medical Center | Miami Beach | Florida | 33140 | — |
| University of Illinois at Chicago Health Sciences Center | Chicago | Illinois | 60612 | — |
| University of Chicago Cancer Research Center | Chicago | Illinois | 60637 | — |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | — |
| Marlene & Stewart Greenebaum Cancer Center, University of Maryland | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital Cancer Center | Boston | Massachusetts | 02114 | — |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | — |
| University of Massachusetts Memorial Medical Center | Worcester | Massachusetts | 01655 | — |
| Ellis Fischel Cancer Center - Columbia | Columbia | Missouri | 65203 | — |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-3330 | — |
| CCOP - Southern Nevada Cancer Research Foundation | Las Vegas | Nevada | 89106 | — |
| Norris Cotton Cancer Center | Lebanon | New Hampshire | 03756 | — |
| Roswell Park Cancer Institute | Buffalo | New York | 14263-0001 | — |
| CCOP - North Shore University Hospital | Manhasset | New York | 11030 | — |
| North Shore University Hospital | Manhasset | New York | 11030 | — |
| Memorial Sloan-Kettering Cancer Center | New York | New York | 10021 | — |
| New York Presbyterian Hospital - Cornell Campus | New York | New York | 10021 | — |
| Mount Sinai Medical Center, NY | New York | New York | 10029 | — |
| CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse | New York | 13210 | — |
| State University of New York - Upstate Medical University | Syracuse | New York | 13210 | — |
| Lineberger Comprehensive Cancer Center, UNC | Chapel Hill | North Carolina | 27599-7295 | — |
| Duke Comprehensive Cancer Center | Durham | North Carolina | 27710 | — |
| CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | 27104-4241 | — |
| Comprehensive Cancer Center of Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina | 27157-1082 | — |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425-0721 | — |
| University of Tennessee, Memphis Cancer Center | Memphis | Tennessee | 38163 | — |
| Vermont Cancer Center | Burlington | Vermont | 05401-3498 | — |
| MBCCOP - Massey Cancer Center | Richmond | Virginia | 23298-0037 | — |
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 NCT00003248, 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 19, 2016 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00003248 live on ClinicalTrials.gov.