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NCT00079443 · ClinicalTrials.gov registry record · Phase 2
FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma
A Phase 2 study, sponsored by National Cancer Institute (NCI).
- Terminated
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT00079443: Clinical Trial Phase 2 study, sponsored by National Cancer Institute (NCI).
NCT00079443 is a Phase 2 study that was terminated before completion, run by National Cancer Institute (NCI). The registered enrollment target is 60 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00079443, a Phase 2 study, was terminated before completion, sponsored by National Cancer Institute (NCI).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This phase I/II trial is studying the best dose of FR901228 when given together with rituximab and fludarabine and to see how well FR901228 works alone in treating patients with relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228 and fludarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Rituximab may increase the effectiveness of chemotherapy drugs by making cancer cells more sensitive to the drugs.
Primary Outcome
Exact confidence interval of the response rate will be calculated.
Interventions
- OTHER laboratory biomarker analysis
- BIOLOGICAL rituximab
- DRUG fludarabine phosphate
- DRUG romidepsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2004-01 |
| Phase | Phase 2 |
Why NCT00079443 stopped before completion
NCT00079443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 4 interventions - of which laboratory biomarker analysis is the first listed.
NCT00079443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00079443 about?
NCT00079443 is a clinical study titled "FR901228 Alone or Combined With Rituximab and Fludarabine in Treating Patients With Relapsed or Refractory Low-Grade B-Cell Non-Hodgkin's Lymphoma". This phase I/II trial is studying the best dose of FR901228 when given together with rituximab and fludarabine and to see how well FR901228 works alone in treating patients with relapsed or refractory low-grade B-cell non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as FR901228 and fludarabi...
What is the current status of trial NCT00079443?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2004-01.
What interventions are being tested in trial NCT00079443?
The interventions under investigation include: laboratory biomarker analysis (OTHER), rituximab (BIOLOGICAL), fludarabine phosphate (DRUG), romidepsin (DRUG).
Who is sponsoring clinical trial NCT00079443?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00079443's enrollment target sits among peer trials
60 1027th of 2000 higher than 868 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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