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NCT00001567 · ClinicalTrials.gov registry record · Phase 2
A Phase II Efficacy Study of Roferon-A in Hairy Cell Leukemia
A Phase 2 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 1
- Study location
NCT00001567: Completed Phase 2 study of Hairy Cell Leukemia, sponsored by National Cancer Institute (NCI).
NCT00001567 is a Phase 2 study of Hairy Cell Leukemia that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 56 participants, below the 69-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (19% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001567, a Phase 2 study of Hairy Cell Leukemia, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 1
- Study location
Study Summary
This study began as an efficacy study of interferon alpha-2a in patients with hairy cell leukemia. It was observed that most patients responded with interferon, but that very few complete responses were being obtained. Studies being done elsewhere confirmed the low complete remission rate. Once interferon was stopped, nearly uniformly disease progression requiring reinstitution of therapy was observed. There appear to be very few if any patients who will not require further therapy after receiving 12 or 18 months of continuous interferon treatment. Because of these findings, and in order to evaluate the safety and efficacy of long-term recombinant interferon-alpha (IFN-Alpha) in patients with hairy cell leukemia, we opted to administer interferon continuously to patients who were initially responsive to this drug. Of the 53 evaluable patients (of the 56 entered on this study), there was one complete remission, 41 partial remissions, 1 minor response, 9 patients with stable disease and only 1 patient with disease progression. Fourteen patients continue to receive interferon without interruption with a median duration of continuous interferon treatment of 9.2 years. Thirty-four patients discontinued interferon for a variety of reasons, the most common being the development of acquired interferon resistance in association with interferon antibodies. The resistance to interferon was manifested early, in the first 18 months of treatment, except in two cases. An important finding in this study is the continued slow, but significant, hematologic improvement in absolute granulocyte and platelet counts beyond 18 months of therapy, thereby indicating that prolonged treatment results in continued benefit rather than the production of antibodies with subsequent development of interferon resistance. Although it is clear from this study that hairy cell leukemia can be controlled in the long-term with interferon, longer follow-up will be necessary to determine if continuous therap
Conditions Studied
Interventions
- DRUG Roferon-A
Study Locations (1)
Maryland
- National Cancer Institute (NCI) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 1997-01 |
| Est. Completion | 2002-04 |
| Phase | Phase 2 |
What the finished NCT00001567 record still lists
NCT00001567 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 69-participant average among 15 other Hairy Cell Leukemia trials with a reported enrollment target (19% lower).
The record links to 1 condition, with Hairy Cell Leukemia appearing as the primary indexed condition, and to 1 intervention - of which Roferon-A is the first listed.
NCT00001567 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT00001567 about?
NCT00001567 is a clinical study titled "A Phase II Efficacy Study of Roferon-A in Hairy Cell Leukemia". This study began as an efficacy study of interferon alpha-2a in patients with hairy cell leukemia. It was observed that most patients responded with interferon, but that very few complete responses were being obtained. Studies being done elsewhere confirmed the low complete remission rate. Once inte...
What is the current status of trial NCT00001567?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 1997-01. Estimated completion is 2002-04.
What conditions does trial NCT00001567 study?
This clinical trial studies the following conditions: Hairy Cell Leukemia.
What interventions are being tested in trial NCT00001567?
The interventions under investigation include: Roferon-A (DRUG).
Who is sponsoring clinical trial NCT00001567?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001567 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hairy Cell Leukemia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00001567's enrollment target sits among peer trials
56 8th of 15 higher than 8 of 15 other Hairy Cell Leukemia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hairy Cell Leukemia 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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