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NCT00918723 · ClinicalTrials.gov registry record · Phase 1
Vorinostat, Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
A Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00918723: Completed Phase 1 study, sponsored by Fred Hutchinson Cancer Center.
NCT00918723 is a Phase 1 study that has completed, run by Fred Hutchinson Cancer Center. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00918723, a Phase 1 study, has completed, sponsored by Fred Hutchinson Cancer Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This phase I/II trial studies the side effects and best dose of vorinostat when given together with fludarabine phosphate, cyclophosphamide, and rituximab and to see how well they work in treating patients with previously untreated B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as fludarabine phosphate and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as rituximab, may block cancer growth in different ways by targeting certain cells. Giving vorinostat together with fludarabine phosphate, cyclophosphamide, and rituximab may be a better treatment for CLL or SLL.
Primary Outcome
The MTD of vorinostat in combination with FCR will be defined as the dose level immediately below the dose level at which greater than or equal to 2 patients out of 6 of a cohort experience dose-limiting toxicity. Toxicities will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0. Doses of vorinostat analyzed to reach the MTD were 200 mg, 300 mg and 400 mg.
Interventions
- DRUG Cyclophosphamide
- BIOLOGICAL Rituximab
- DRUG Fludarabine Phosphate
- DRUG Vorinostat
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2009-06 |
| Est. Completion | 2016-10 |
| Phase | Phase 1 |
What the finished NCT00918723 record still lists
NCT00918723 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 4 interventions - of which Cyclophosphamide is the first listed.
NCT00918723 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00918723 about?
NCT00918723 is a clinical study titled "Vorinostat, Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Previously Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma". This phase I/II trial studies the side effects and best dose of vorinostat when given together with fludarabine phosphate, cyclophosphamide, and rituximab and to see how well they work in treating patients with previously untreated B-cell chronic lymphocytic leukemia (CLL) or small lymphocytic lymph...
What is the current status of trial NCT00918723?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2009-06. Estimated completion is 2016-10.
What interventions are being tested in trial NCT00918723?
The interventions under investigation include: Cyclophosphamide (DRUG), Rituximab (BIOLOGICAL), Fludarabine Phosphate (DRUG), Vorinostat (DRUG).
Who is sponsoring clinical trial NCT00918723?
This trial is sponsored by Fred Hutchinson Cancer Center, which has 483 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00918723's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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