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NCT01279616 · ClinicalTrials.gov registry record · Phase 2
A Reduced Toxicity Allogeneic Unrelated Donor Stem Cell Transplantation (SCT) for Severe Sickle Cell Disease
A Phase 2 study, sponsored by Nationwide Children's Hospital.
- Terminated
- Registry status
- Phase 2
- Development phase
- 8
- Enrollment target
NCT01279616 is a Phase 2 study that was terminated before completion, run by Nationwide Children's Hospital. The registered enrollment target is 8 participants.
The verdict
NCT01279616, a Phase 2 study, was terminated before completion, sponsored by Nationwide Children's Hospital.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 8 participants
- Enrollment target
Study Summary
Majority of patients who are eligible for allogeneic HSCT for cure of severe sickle cell disease lack a matched family donor. This study aims for cure of sickle cell disease by performing unrelated donor (outside family) allogeneic HSCT. Donors or unrelated cord blood units will be selected from the NMDP database. It is designed to estimate the safety of a novel reduced toxicity, yet an immunosuppressive and myeloablative preparative regimen. This is meant for patients \<21 years old who have severe complications from sickle cell and do not have matched sibling donors in the family to undergo stem cell transplant. Patients will undergo transplant using unrelated donor stem cells after receiving the protocol therapy. They will be followed for 1 year to monitor for engraftment of donor cells and complications like graft versus host disease (GVHD), infections and death.
Interventions
- DRUG Cyclophosphamide
- DRUG Busulfan
- DRUG Rituximab
- DRUG ATG
- DRUG Fludarabine monophosphate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2010-09 |
| Est. Completion | 2015-01 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01279616
The ClinicalTrials.gov registry entry for NCT01279616 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Nationwide Children's Hospital, which has 188 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT01279616 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01279616 about?
NCT01279616 is a clinical study titled "A Reduced Toxicity Allogeneic Unrelated Donor Stem Cell Transplantation (SCT) for Severe Sickle Cell Disease". Majority of patients who are eligible for allogeneic HSCT for cure of severe sickle cell disease lack a matched family donor. This study aims for cure of sickle cell disease by performing unrelated donor (outside family) allogeneic HSCT. Donors or unrelated cord blood units will be selected from the...
What is the current status of trial NCT01279616?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 8 participants. The study started on 2010-09. Estimated completion is 2015-01.
What interventions are being tested in trial NCT01279616?
The interventions under investigation include: Cyclophosphamide (DRUG), Busulfan (DRUG), Rituximab (DRUG), ATG (DRUG), Fludarabine monophosphate (DRUG).
Who is sponsoring clinical trial NCT01279616?
This trial is sponsored by Nationwide Children's Hospital, which has 188 total clinical trials registered on ClinicalTrials.gov.
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