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NCT01336712 · ClinicalTrials.gov registry record · Phase 2
Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases
A Phase 2 study, sponsored by Northside Hospital.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
NCT01336712 is a Phase 2 study that has completed, run by Northside Hospital. The registered enrollment target is 30 participants.
The verdict
NCT01336712, a Phase 2 study, has completed, sponsored by Northside Hospital.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
Study Summary
In this study, patients will receive a myeloablative preparative regimen consisting of fludarabine and total body irradiation (TBI), followed by a T cell replete, mobilized peripheral blood stem cell (PBSC) allograft from a partially matched related donor. All patients will receive post-transplant Cy in addition to standard post transplant immunosuppression with tacrolimus and MMF. The treatment protocol will be essentially identical to the prior study, with the exception of the substitution of TBI for Busulfan. The investigators hypothesize that this change will significantly reduce the risk of HC, while maintaining the efficacy of the transplant.
Interventions
- PROCEDURE Peripheral Blood Stem Cell Transplant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-04 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01336712
The ClinicalTrials.gov registry entry for NCT01336712 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Northside Hospital, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Peripheral Blood Stem Cell Transplant is the first listed.
NCT01336712 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01336712 about?
NCT01336712 is a clinical study titled "Total Body Irradiation/Fludarabine Based Ablative Haploidentical Transplant for Hematologic Diseases". In this study, patients will receive a myeloablative preparative regimen consisting of fludarabine and total body irradiation (TBI), followed by a T cell replete, mobilized peripheral blood stem cell (PBSC) allograft from a partially matched related donor. All patients will receive post-transplant C...
What is the current status of trial NCT01336712?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2011-04. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01336712?
The interventions under investigation include: Peripheral Blood Stem Cell Transplant (PROCEDURE).
Who is sponsoring clinical trial NCT01336712?
This trial is sponsored by Northside Hospital, which has 26 total clinical trials registered on ClinicalTrials.gov.
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