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NCT00586690 · ClinicalTrials.gov registry record · Phase 1
Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT
A Phase 1 study, sponsored by David Rizzieri, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
NCT00586690: Completed Phase 1 study, sponsored by David Rizzieri, MD.
NCT00586690 is a Phase 1 study that has completed, run by David Rizzieri, MD. The registered enrollment target is 47 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00586690, a Phase 1 study, has completed, sponsored by David Rizzieri, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
Study Summary
Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation (SCT) from matched donors. This pilot study will evaluate toxicity including mortality, occurrence of acute graft versus host disease and other severe toxicity.
Primary Outcome
Evaluate the toxicity post-infusion including mortality, occurrence of acute graft versus host disease (GVHD) and other severe toxicity until a minimum of 8 weeks following the last infusion, then at least monthly for 3 additional months. Unacceptable toxicity was defined as grade ≥ III aGVHD of the gut or liver or Grade 4 aGVHD of the skin lasting \> 7 days; other Grade 4 toxicity from the procedure in the major organs that lasted \> 5 days; or treatment-related mortality (TRM). Though these in
Interventions
- PROCEDURE Donor Apheresis
- DEVICE NK Cell infusion using CD56 monoclonal antibody
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2005-05 |
| Est. Completion | 2013-11 |
| Phase | Phase 1 |
What the finished NCT00586690 record still lists
NCT00586690 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (22% lower).
The record links to 0 conditions, and to 2 interventions - of which Donor Apheresis is the first listed.
NCT00586690 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00586690 about?
NCT00586690 is a clinical study titled "Safety Trial of NK DLI From 6/6 HLA Matched Family Member Following Nonmyeloablative ASCT". Evaluate the safety of natural killer (NK) cell infusion using CD56 monoclonal antibody selected with Miltenyi Biotec system following nonmyeloablative stem cell transplantation (SCT) from matched donors. This pilot study will evaluate toxicity including mortality, occurrence of acute graft versus h...
What is the current status of trial NCT00586690?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2005-05. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00586690?
The interventions under investigation include: Donor Apheresis (PROCEDURE), NK Cell infusion using CD56 monoclonal antibody (DEVICE).
Who is sponsoring clinical trial NCT00586690?
This trial is sponsored by David Rizzieri, MD, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00586690's enrollment target sits among peer trials
47 1053rd of 2000 higher than 943 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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