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NCT00794820 · ClinicalTrials.gov registry record · Phase 2
Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline
A Phase 2 study, sponsored by M.D. Anderson Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 66
- Enrollment target
NCT00794820: Completed Phase 2 study, sponsored by M.D. Anderson Cancer Center.
NCT00794820 is a Phase 2 study that has completed, run by M.D. Anderson Cancer Center. The registered enrollment target is 66 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00794820, a Phase 2 study, has completed, sponsored by M.D. Anderson Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 66 participants
- Enrollment target
Study Summary
Primary Objective: * To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL. Secondary Objective: * To evaluate remission duration and survival.
Primary Outcome
CR Rate is defined as number of all treated participants with CR as defined by 2008 IWCLL update of NCI-WG response criteria: Complete remission (CR), requiring absence of peripheral blood clonal lymphocytes by immunophenotyping, absence of lymphadenopathy, absence of hepatomegaly or splenomegaly, absence of constitutional symptoms and satisfactory blood counts; Complete remission with incomplete marrow recovery (CRi), defined as CR above, but without normal blood counts; Partial remission (PR),
Interventions
- DRUG Cyclophosphamide
- DRUG Rituximab
- DRUG Fludarabine Phosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2003-12 |
| Est. Completion | 2014-12 |
| Phase | Phase 2 |
What the finished NCT00794820 record still lists
NCT00794820 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT00794820 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00794820 about?
NCT00794820 is a clinical study titled "Fludarabine, Cyclophosphamide, and Rituximab - High Dose Frontline". Primary Objective: * To evaluate the efficacy (combined morphologic and flow remissions) of a combination of fludarabine, cyclophosphamide and multiple dose rituximab as frontline therapy for CLL. Secondary Objective: * To evaluate remission duration and survival.
What is the current status of trial NCT00794820?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 66 participants. The study started on 2003-12. Estimated completion is 2014-12.
What interventions are being tested in trial NCT00794820?
The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (DRUG), Fludarabine Phosphate (DRUG).
Who is sponsoring clinical trial NCT00794820?
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
How this trial's enrollment target compares
Where NCT00794820's enrollment target sits among peer trials
66 975th of 2000 higher than 1,014 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
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