Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00230282 · ClinicalTrials.gov registry record · Phase 2
Phase 2 Fludarabine, Cytoxan and FCCAM <Alemtuzumab> in Untreated B-Cell Chronic Lymphocytic Leukemia
A Phase 2 study, sponsored by Steven E. Coutre.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
NCT00230282: Completed Phase 2 study, sponsored by Steven E. Coutre.
NCT00230282 is a Phase 2 study that has completed, run by Steven E. Coutre. The registered enrollment target is 25 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00230282, a Phase 2 study, has completed, sponsored by Steven E. Coutre.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
Study Summary
The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.
Primary Outcome
Response criteria as per the NCI-WG Revised Guidelines for B-CLL Complete remission: No lymphadenopathy by physical exam No hepatomegaly or splenomegaly Absence of constitutional symptoms Polymorphonuclear leukocytes \> 1,500/uL, Platelets \> 100,000/uL, Hemoglobin \> 11.0 g/dL Bone marrow aspirate and biopsy normocellular with \< 30% lymphocytes Absent lymphoid nodules Partial remission: * 50% decrease in peripheral blood lymphocyte count from the pretreatment baseline value * 50% reduction
Interventions
- DRUG Fludarabine
- DRUG Alemtuzumab
- DRUG Cytoxan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2004-07 |
| Est. Completion | 2011-10 |
| Phase | Phase 2 |
What the finished NCT00230282 record still lists
NCT00230282 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Fludarabine is the first listed.
NCT00230282 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00230282 about?
NCT00230282 is a clinical study titled "Phase 2 Fludarabine, Cytoxan and FCCAM <Alemtuzumab> in Untreated B-Cell Chronic Lymphocytic Leukemia". The primary objective of this study was to evaluate the safety and efficacy of the combination of fludarabine and cyclophosphamide in previously untreated CLL patients. Participants will receive fludarabine and cyclophosphamide on days 1, 2, and 3 of six 28-day cycles.
What is the current status of trial NCT00230282?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2004-07. Estimated completion is 2011-10.
What interventions are being tested in trial NCT00230282?
The interventions under investigation include: Fludarabine (DRUG), Alemtuzumab (DRUG), Cytoxan (DRUG).
Who is sponsoring clinical trial NCT00230282?
This trial is sponsored by Steven E. Coutre, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00230282's enrollment target sits among peer trials
25 1719th of 2000 higher than 245 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01166854 · 25 participants
Characterization of Familial Myopathy and Paget Disease of Bone
- NCT01913106 · 25 participants · Phase 1
HSV-tk + Valacyclovir Therapy in Combination With Brachytherapy for Recurrent Prostate Cancer
- NCT02138669 · 25 participants · NA
Intacs Prescription Inserts for Keratoconus Patients
- NCT02174549 · 25 participants · Phase 1
Dose-defining Study of Tirapazamine Combined With Embolization in Liver Cancer
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia