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NCT01350245 · ClinicalTrials.gov registry record · Phase 2
Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor
A Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Completed
- Registry status
- Phase 2
- Development phase
- 28
- Enrollment target
NCT01350245: Completed Phase 2 study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
NCT01350245 is a Phase 2 study that has completed, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 28 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01350245, a Phase 2 study, has completed, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 28 participants
- Enrollment target
Study Summary
The primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same or better than the historical DFS of patients with similar diagnoses and ages undergoing matched sibling HSCT. Based on a review of the literature a DFS rate of 50% or better at 1 year would meet the criterion for an effective alternative therapy. A DFS rate of 75% or better would imply superior efficacy of the TJU 2 Step approach over T-replete matched sibling HSCT.
Primary Outcome
1-year post-transplant disease free survival (DFS), defined as success if a patient is alive and disease free at 1-year post-transplant.
Interventions
- DRUG Cyclophosphamide
- RADIATION Total Body Irradiation (TBI)
- DRUG Tacrolimus
- DRUG Mycophenolate Mofetil (MMF)
- BIOLOGICAL Donor Lymphocyte Infusion (DLI)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-05 |
| Phase | Phase 2 |
What the finished NCT01350245 record still lists
NCT01350245 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (79% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01350245 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01350245 about?
NCT01350245 is a clinical study titled "Bone Marrow Transplantation of Patients in Remission Using Partially Matched Relative Donor". The primary hypothesis of this research study is that patients in remission undergoing myeloablative haploidentical hematopoietic stem cell transplantation (HSCT) on the Thomas Jefferson University (TJU) 2 Step treatment regimen will have a disease-free survival (DFS) rate at 1 year that is the same...
What is the current status of trial NCT01350245?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 28 participants. The study started on 2010-07. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01350245?
The interventions under investigation include: Cyclophosphamide (DRUG), Total Body Irradiation (TBI) (RADIATION), Tacrolimus (DRUG), Mycophenolate Mofetil (MMF) (DRUG), Donor Lymphocyte Infusion (DLI) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01350245?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01350245's enrollment target sits among peer trials
28 1677th of 2000 higher than 304 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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