Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00525603 · ClinicalTrials.gov registry record · Phase 2
CFAR Study in Patients With Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00525603: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00525603 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 60 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00525603, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
Primary Objective: 1\. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) to increase the proportion of patients with \<5% CD5/CD19+ cells in bone marrow to 66% following 3 courses of treatment without significantly increasing the incidence of pneumonia or sepsis compared to a historic group of patients treated with the combination fludarabine, cyclophosphamide, and rituximab (FCR). Second Objectives: 1. Assess complete remission (CR), nodular partial remission (nPR), and partial remission (PR) rates (overall response) in high-risk, previously untreated patients with CLL treated with CFAR. 2. Evaluate molecular remission in bone marrow by polymerase chain reaction (PCR) for the clonal immunoglobulin heavy chain variable gene in responders treated with CFAR. 3. Assess immune parameters including blood T cell counts and subset distribution and serum immunoglobulin levels pretreatment, during treatment, and post-treatment in patients treated with CFAR.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Alemtuzumab
- DRUG Rituximab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2005-06 |
| Est. Completion | 2011-07 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00525603
The ClinicalTrials.gov registry entry for NCT00525603 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is M.D. Anderson Cancer Center, which has 2,692 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT00525603 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00525603 about?
NCT00525603 is a clinical study titled "CFAR Study in Patients With Chronic Lymphocytic Leukemia". Primary Objective: 1\. Evaluate the ability of Cyclophosphamide, Fludarabine, Alemtuzumab, and Rituximab (CFAR) to increase the proportion of patients with \<5% CD5/CD19+ cells in bone marrow to 66% following 3 courses of treatment without significantly increasing the incidence of pneumonia or seps...
What is the current status of trial NCT00525603?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2005-06. Estimated completion is 2011-07.
What interventions are being tested in trial NCT00525603?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Alemtuzumab (DRUG), Rituximab (DRUG).
Who is sponsoring clinical trial NCT00525603?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, the data changelog, or report a data error.