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NCT00529035 · ClinicalTrials.gov registry record · Phase 1
Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease
A Phase 1 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 29
- Enrollment target
NCT00529035: Completed Phase 1 study, sponsored by Dana-Farber Cancer Institute.
NCT00529035 is a Phase 1 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 29 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00529035, a Phase 1 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 29 participants
- Enrollment target
Study Summary
The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize their body (the host) as foreign and attempt to "reject" it. Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Treatment options are limited, and it is thought that IL-2 may help to control chronic GVHD.
Primary Outcome
Three dose levels were evaluated to determine the maximally tolerated dose (MTD): Dose level A: 0.3 x 10\^6 IU/m\^2/day Dose level B: 1.0 x 10\^6 IU/m\^2/day Dose level C: 3.0 x 10\^6 IU/m\^2/day Once the MTD (dose level B) was established, an additional 10 participants were enrolled at this dose.
Interventions
- DRUG Interleukin-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2007-08 |
| Est. Completion | 2020-05-27 |
| Phase | Phase 1 |
What the finished NCT00529035 record still lists
NCT00529035 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (52% lower).
The record links to 0 conditions, and to 1 intervention - of which Interleukin-2 is the first listed.
NCT00529035 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00529035 about?
NCT00529035 is a clinical study titled "Ultra-Low Dose Interleukin-2 for Refractory Chronic Graft Versus Host Disease". The purpose of this research study is to determine the safety of IL-2 and the highest dose of this drug that can be given safely to people with chronic graft versus host disease (GVHD). Chronic GVHD is a medical condition that may occur after patients receive a bone marrow, stem cell or cord blood t...
What is the current status of trial NCT00529035?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 29 participants. The study started on 2007-08. Estimated completion is 2020-05-27.
What interventions are being tested in trial NCT00529035?
The interventions under investigation include: Interleukin-2 (DRUG).
Who is sponsoring clinical trial NCT00529035?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00529035's enrollment target sits among peer trials
29 1440th of 2000 higher than 554 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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