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NCT00228852 · ClinicalTrials.gov registry record · Phase 1
IMM 0212: Busulfan With Fludarabine and Antithymocyte Globulin as Preparative Therapy for Hematopoietic Stem Cell Transplant for the Treatment of Severe Congenital T-Cell Immunodeficiency
A Phase 1 study of Severe Combined Immunodeficiency and T-Cell Immune Deficiency Diseases, sponsored by Emory University.
- Completed
- Registry status
- Phase 1
- Development phase
- 1
- Study location
NCT00228852 is a Phase 1 study of Severe Combined Immunodeficiency and T-Cell Immune Deficiency Diseases that has completed, run by Emory University. The trial reports 1 study location across 1 state.
The verdict
NCT00228852, a Phase 1 study of Severe Combined Immunodeficiency and T-Cell Immune Deficiency Diseases, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 1
- Study location
Study Summary
This is a multi-institution, single arm, non-randomized pilot study coordinated by the Pediatric Blood and Marrow Transplant Consortium. Eligible patients will have severe combined immunodeficiency syndrome (SCID) or severe T-cell immunodeficiency disorder. Patients with these disorders do not have properly functioning immune systems. Without treatment, these disorders result in early childhood death. The standard treatment used for these diseases is to give the patient a stem cell transplant from a matched donor. The donor cells can be from a family member, an unrelated marrow donor or umbilical cord blood. The donor source will impact on transplant risks and approaches to the preparative regimen. There have been many different preparative regimens used for patients with SCIDS or severe T-cell immunodeficiency syndromes. Some patients have gotten no preparative regimen, while others have gotten only antithymocyte globulin (ATG; immune proteins made in horses that, when given, will kill lymphocytes). Still other patients have gotten conventional chemotherapy. In children treated with nothing or ATG alone, there is an increased risk of graft failure or only partial engraftment. When this happens, patients need life-long therapy with immunoglobulins to support the immune system. Children treated with chemotherapy generally have full immune recovery, but also may have major side effects from the chemotherapy. The side effects include infection, organ failure and infertility. This protocol, in combination with a parallel study with a separate preparative regimen, will attempt to answer the question of which patients with primary immunodeficiencies need a preparative regimen and what intensity is needed. Patients will be enrolled according to disease type and donor source. The purpose of this study is to see how much chemotherapy is actually needed for the transplant to work. To be able to do this and still make the transplant work, the drugs used to temporarily weaken
Conditions Studied
Interventions
- DRUG Busulfan, Fludarabine and ATG
Study Locations (1)
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Est. Completion | 2006-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00228852
The ClinicalTrials.gov registry entry for NCT00228852 describes a study currently listed as completed, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Severe Combined Immunodeficiency appearing as the primary indexed condition, and to 1 intervention - of which Busulfan, Fludarabine and ATG is the first listed.
NCT00228852 reports 1 study location spanning 1 distinct geographic area - top geographies include Georgia.
Frequently Asked Questions
What is clinical trial NCT00228852 about?
NCT00228852 is a clinical study titled "IMM 0212: Busulfan With Fludarabine and Antithymocyte Globulin as Preparative Therapy for Hematopoietic Stem Cell Transplant for the Treatment of Severe Congenital T-Cell Immunodeficiency". This is a multi-institution, single arm, non-randomized pilot study coordinated by the Pediatric Blood and Marrow Transplant Consortium. Eligible patients will have severe combined immunodeficiency syndrome (SCID) or severe T-cell immunodeficiency disorder. Patients with these disorders do not have ...
What is the current status of trial NCT00228852?
This trial is currently completed. It is a Phase 1 study. Estimated completion is 2006-11.
What conditions does trial NCT00228852 study?
This clinical trial studies the following conditions: Severe Combined Immunodeficiency, T-Cell Immune Deficiency Diseases.
What interventions are being tested in trial NCT00228852?
The interventions under investigation include: Busulfan, Fludarabine and ATG (DRUG).
Who is sponsoring clinical trial NCT00228852?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00228852 being conducted?
This trial has 1 study location across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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