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NCT01350232 · ClinicalTrials.gov registry record · NA
Treatment of Sickle Cell Anemia With Stem Cell Transplant
A NA study, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- Terminated
- Registry status
- NA
- Development phase
- 2
- Enrollment target
NCT01350232 is a NA study that was terminated before completion, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University. The registered enrollment target is 2 participants.
The verdict
NCT01350232, a NA study, was terminated before completion, sponsored by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.
- TERMINATED
- Registry status
- NA
- Development phase
- 2 participants
- Enrollment target
Study Summary
This is a clinical research trial in which a novel preparatory regimen was developed for bone marrow transplant (BMT) which eliminates the primary obstacle to transplant, the lack of a matched sibling donor. It is believed this regimen is sufficiently efficacious and sufficiently gentle to apply to patients with sickle cell anemia and related disorders. It is proposed to characterize the efficacy and toxicity of this regimen in high risk patients with sickle cell anemia using criteria for patient selection that have been accepted in prior BMT trials in patients with sickle cell disease, specifically only the subset of patients whose prior clinical behavior indicates that they are at high risk for serious morbidity and early mortality. In addition, it is proposed to characterize the pathophysiology of a consistent febrile response seen in the haploidentical BMT regimen the investigators have developed at Thomas Jefferson University (TJU). The primary goal of this study is to determine the response rate to a reduced intensity conditioning regimen which consists of fludarabine, cytarabine, low dose total body irradiation and cyclophosphamide in patients with severe sickle cell anemia.
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Cytarabine
- RADIATION Total Body Irradiation
- DEVICE Cellular Infusions
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2009-09 |
| Est. Completion | 2011-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01350232
The ClinicalTrials.gov registry entry for NCT01350232 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 2 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.
NCT01350232 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01350232 about?
NCT01350232 is a clinical study titled "Treatment of Sickle Cell Anemia With Stem Cell Transplant". This is a clinical research trial in which a novel preparatory regimen was developed for bone marrow transplant (BMT) which eliminates the primary obstacle to transplant, the lack of a matched sibling donor. It is believed this regimen is sufficiently efficacious and sufficiently gentle to apply to ...
What is the current status of trial NCT01350232?
This trial is currently terminated. It is a NA study. The enrollment target is 2 participants. The study started on 2009-09. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01350232?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Cytarabine (DRUG), Total Body Irradiation (RADIATION), Cellular Infusions (DEVICE).
Who is sponsoring clinical trial NCT01350232?
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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