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NCT00968864 · ClinicalTrials.gov registry record · Phase 2
T-cell Depleted Alternative Donor Transplantation
A Phase 2 study, sponsored by Wake Forest University Health Sciences.
- Terminated
- Registry status
- Phase 2
- Development phase
- 53
- Enrollment target
NCT00968864: Clinical Trial Phase 2 study, sponsored by Wake Forest University Health Sciences.
NCT00968864 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 53 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00968864, a Phase 2 study, was terminated before completion, sponsored by Wake Forest University Health Sciences.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 53 participants
- Enrollment target
Study Summary
The primary purpose is to determine the ability of CD34+ selection and T cell depletion using the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from an alternative (unrelated and mismatched related) donor. The secondary objectives include evaluation of engraftment, immune recovery, and post-transplant infections. Patients requiring stem cell transplants for either malignant (cancerous) or non-malignant disease will be included in the study. The recipients will be grouped into one of two groups based on whether the donor is mismatched related (Cohort A) or unrelated (Cohort B). The patient will receive a conditioning regimen including chemotherapy drugs and/or total body irradiation based on the disease for which the transplant is performed.
Primary Outcome
Severe GVHD defined as grade III/IV GVHD.
Interventions
- DEVICE CliniMACS® (T cell depletion)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 53 participants |
| Start Date | 2009-08 |
| Est. Completion | 2016-11 |
| Phase | Phase 2 |
Why NCT00968864 stopped before completion
NCT00968864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which CliniMACS® (T cell depletion) is the first listed.
NCT00968864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00968864 about?
NCT00968864 is a clinical study titled "T-cell Depleted Alternative Donor Transplantation". The primary purpose is to determine the ability of CD34+ selection and T cell depletion using the CliniMACS® device to prevent severe acute graft-versus-host disease (GVHD) in patients receiving a stem cell transplant from an alternative (unrelated and mismatched related) donor. The secondary object...
What is the current status of trial NCT00968864?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 53 participants. The study started on 2009-08. Estimated completion is 2016-11.
What interventions are being tested in trial NCT00968864?
The interventions under investigation include: CliniMACS® (T cell depletion) (DEVICE).
Who is sponsoring clinical trial NCT00968864?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00968864's enrollment target sits among peer trials
53 1171st of 2000 higher than 820 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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