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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 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.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01350245
The ClinicalTrials.gov registry entry for NCT01350245 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University, which has 138 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01350245 reports 0 study locations.
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.
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