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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 is a Phase 2 study that was terminated before completion, run by Wake Forest University Health Sciences. The registered enrollment target is 53 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00968864
The ClinicalTrials.gov registry entry for NCT00968864 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 53 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Wake Forest University Health Sciences, which has 1,140 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CliniMACS® (T cell depletion) is the first listed.
NCT00968864 reports 0 study locations.
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.
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