Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00426517 · ClinicalTrials.gov registry record · Early Phase 1
Donor Stem Cell Transplantation for Congenital Immunodeficiencies
A Early Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 48
- Enrollment target
NCT00426517 is a Early Phase 1 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 48 participants.
The verdict
NCT00426517, a Early Phase 1 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 48 participants
- Enrollment target
Study Summary
This study uses transplantation to treat patients with problems in their immune system. The immune system cells come from the bone marrow where they grow from special cells called stem cells. Giving patients stem cells from someone else may help to cure many patients with certain immune diseases. This is called 'bone marrow transplantation'. This procedure can have side effects that are life-threatening. To try to make transplantation safer we are using lower doses of the medications used in preparing the patient for the transplant. 'Conditioning' treatments are given to patients to create space in their bone marrow. This lets the cells of the donor go into the bone marrow and produce normal immune cells. This study will use lower doses of a drug called busulfan and lower doses of radiation than what are currently being used in other kinds of bone marrow transplantation for other diseases. Another problem that can occur with bone marrow transplantation is 'graft-versus-host disease'. This happens when the cells of the donor attacks different parts of the patient s body. This study will use a medicine called sirolimus instead of the usual medicine, cyclosporine, to prevent graft-versus-host disease. To go onto this study, you must have: 1. A severe immune deficiency, such as chronic granulomatous disease or leukocyte adhesion deficiency. 2. Have problems from the disease that call for stem cell transplantation. 3. You must also be between the ages of 2 and 40 years. Two groups of patients are included in this study: 1. Patients who have a brother or sister that have stem cells that match the patient. This is known as an allogeneic matched sibling transplant. 2. Patients who do not have a matched sibling donor but have a donor that matches in the National Marrow Donor Program. This is know as matched unrelated donor transplantation. Patients will have the following procedures: * To create space in the bone marrow, patients are given two drugs, Campath-1H and b
Interventions
- DRUG Busulfan
- DRUG Total Body Irradiation (TBI)
- DRUG Campath 1H
- DRUG Horse Anti-human Thymocyte Globulin (h-ATG)
- DRUG Sirolimus or equivalent based on response
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2007-01-19 |
| Est. Completion | 2019-11-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00426517
The ClinicalTrials.gov registry entry for NCT00426517 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 48 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Busulfan is the first listed.
NCT00426517 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00426517 about?
NCT00426517 is a clinical study titled "Donor Stem Cell Transplantation for Congenital Immunodeficiencies". This study uses transplantation to treat patients with problems in their immune system. The immune system cells come from the bone marrow where they grow from special cells called stem cells. Giving patients stem cells from someone else may help to cure many patients with certain immune diseases. Th...
What is the current status of trial NCT00426517?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 48 participants. The study started on 2007-01-19. Estimated completion is 2019-11-01.
What interventions are being tested in trial NCT00426517?
The interventions under investigation include: Busulfan (DRUG), Total Body Irradiation (TBI) (DRUG), Campath 1H (DRUG), Horse Anti-human Thymocyte Globulin (h-ATG) (DRUG), Sirolimus or equivalent based on response (DRUG).
Who is sponsoring clinical trial NCT00426517?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.