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NCT00854581 · ClinicalTrials.gov registry record · Phase 4
Zidovudine, Interferon Alfa-2b, PEG-Interferon Alfa-2b in Patients With HTLV-I Associated Adult T-Cell Leukemia/Lymphoma
A Phase 4 study, sponsored by University of Miami.
- Terminated
- Registry status
- Phase 4
- Development phase
- 13
- Enrollment target
NCT00854581: Clinical Trial Phase 4 study, sponsored by University of Miami.
NCT00854581 is a Phase 4 study that was terminated before completion, run by University of Miami. The registered enrollment target is 13 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00854581, a Phase 4 study, was terminated before completion, sponsored by University of Miami.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 13 participants
- Enrollment target
Study Summary
RATIONALE: Human T-cell lymphotropic virus type 1 (HTLV-1) can cause cancer. Zidovudine is an antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune system and slow down or keep the cancer cell from growing. PURPOSE: This clinical trial is studying how well giving zidovudine together with interferon alfa-2b and PEG-interferon alfa-2b works in treating patients with human T-cell lymphotropic virus type 1-associated adult T-cell leukemia/lymphoma.
Primary Outcome
Number of patients achieving clinical response (complete response (CR) + partial response (PR)) who lack interferon regulatory factor 4 (IRF-4) or c-Rel biomarker expression. Treatment response was assessed according to the International Consensus Review's adult T-cell leukemia/lymphoma (ATLL) consensus report by Tsukasaki et al published in the Journal of Clinical Oncology (JCO) in 2009. For imaging, Cheson criteria was used to assess response: * Complete response (CR): Disappearance of all c
Interventions
- DRUG Zidovudine
- DRUG Valproic Acid
- BIOLOGICAL PEG-interferon alfa-2b
- BIOLOGICAL Interferon alfa-2b
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2007-11 |
| Est. Completion | 2011-11 |
| Phase | Phase 4 |
Why NCT00854581 stopped before completion
NCT00854581 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 4 interventions - of which Zidovudine is the first listed.
NCT00854581 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00854581 about?
NCT00854581 is a clinical study titled "Zidovudine, Interferon Alfa-2b, PEG-Interferon Alfa-2b in Patients With HTLV-I Associated Adult T-Cell Leukemia/Lymphoma". RATIONALE: Human T-cell lymphotropic virus type 1 (HTLV-1) can cause cancer. Zidovudine is an antiviral drug that acts against the human T-cell lymphotropic virus type 1. Giving zidovudine, interferon alfa-2b, and PEG-interferon alfa-2b together may stimulate the immune system and slow down or keep ...
What is the current status of trial NCT00854581?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 13 participants. The study started on 2007-11. Estimated completion is 2011-11.
What interventions are being tested in trial NCT00854581?
The interventions under investigation include: Zidovudine (DRUG), Valproic Acid (DRUG), PEG-interferon alfa-2b (BIOLOGICAL), Interferon alfa-2b (BIOLOGICAL).
Who is sponsoring clinical trial NCT00854581?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00854581's enrollment target sits among peer trials
13 1910th of 2000 higher than 88 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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