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NCT01043640 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders
A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01043640 is a Phase 2 study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 46 participants.
The verdict
NCT01043640, a Phase 2 study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
Rationale: Chemotherapy administration before a donor stem cell transplant is necessary to stop the patient's immune system from rejecting the donor's stem cells. When healthy stem cells from a donor are infused into the patient, the donor white blood cells can provide the missing enzyme that causes the metabolic disease. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving a monoclonal antibody, alemtuzumab, before transplant and cyclosporine and mycophenolate mofetil before and after transplant may stop this from happening. This may be an effective treatment for inherited metabolic disorders. Purpose: The design of this study is to achieve donor cell engraftment in patients with standard-risk inherited metabolic diseases with limited peri-transplant morbidity and mortality. This will be achieved through the administration of the chemotherapy regimen described. The intention is to follow transplanted patient for years after transplant monitoring them for complications of their disease and assisting families with a multifaceted interdisciplinary approach.
Interventions
- DRUG Cyclophosphamide
- DRUG Busulfan
- DRUG Cyclosporine A
- PROCEDURE Allogeneic stem cell transplantation
- DRUG Campath-1H
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2009-12 |
| Est. Completion | 2017-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01043640
The ClinicalTrials.gov registry entry for NCT01043640 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Masonic Cancer Center, University of Minnesota, which has 249 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01043640 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01043640 about?
NCT01043640 is a clinical study titled "Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders". Rationale: Chemotherapy administration before a donor stem cell transplant is necessary to stop the patient's immune system from rejecting the donor's stem cells. When healthy stem cells from a donor are infused into the patient, the donor white blood cells can provide the missing enzyme that causes...
What is the current status of trial NCT01043640?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2009-12. Estimated completion is 2017-06.
What interventions are being tested in trial NCT01043640?
The interventions under investigation include: Cyclophosphamide (DRUG), Busulfan (DRUG), Cyclosporine A (DRUG), Allogeneic stem cell transplantation (PROCEDURE), Campath-1H (DRUG).
Who is sponsoring clinical trial NCT01043640?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
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