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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: Completed Phase 2 study, sponsored by Northside Hospital.
NCT01336712 is a Phase 2 study that has completed, run by Northside Hospital. The registered enrollment target is 30 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
1.1 To estimate the incidence of BK virus-associated hemorrhagic cystitis following a TBI-based myeloablative haploidentical HSCT in patients with high risk hematologic malignancies.
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 |
What the finished NCT01336712 record still lists
NCT01336712 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 1 intervention - of which Peripheral Blood Stem Cell Transplant is the first listed.
NCT01336712 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01336712's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 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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