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NCT00001765 · ClinicalTrials.gov registry record · Phase 1
Stem Cell Transplant Following Low-Intensity Chemotherapy to Treat Chronic Granulomatous Disease
A Phase 1 study of Chronic Granulomatous Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
- 1
- Study location
NCT00001765 is a Phase 1 study of Chronic Granulomatous Disease that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 60 participants, above the 27-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (122% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00001765, a Phase 1 study of Chronic Granulomatous Disease, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
- 1
- Study location
Study Summary
This study will investigate the safety and effectiveness of a modified stem cell transplant procedure for treating chronic granulomatous disease (CGD) in patients with active infection. CGD is an inherited disorder of neutrophils-a type of infection-fighting white blood cell-that leaves patients vulnerable to life-threatening infections. Transplantation of donated stem cells (cells produced by the bone marrow that mature into the different blood components-white cells, red cells and platelets) can cure CGD. However, this procedure carries a significant risk of death, particularly in patients with active infection, because it requires completely suppressing the immune system with high-dose chemotherapy and radiation. In addition, lymphocytes-another type of infection-fighting white blood cell-from the donor may cause what is called graft vs. host disease (GvHD), in which the donor cells recognize the patient's cells as foreign and mount an immune response to destroy them. To try to reduce these risks, patients in this study will be given low-dose chemotherapy and no radiation, a regimen that is easier for the body to tolerate and involves a shorter period of complete immune suppression. Also, the donor's lymphocytes will be removed from the rest of the stem cells to be transplanted, reducing the risk of GvHD. Patients with CGD between the ages of age 1 and 55 years old who do not have an active infection and who have a family member that is a well matched donor may be eligible for this study. Candidates will have a medical history, physical examination and blood tests, lung and heart function tests, X-rays of the chest and sinuses, and dental and eye examinations. A bone marrow sample may be taken to evaluate disease status. This test, done under a local anesthetic, uses a special needle to draw bone marrow from the hipbone. Stem cells will be collected from both the patient and donor. To do this, the hormone G-CSF will be injected under the skin for several days t
Conditions Studied
Interventions
- DEVICE Nexell Isolex with T-cell Depletion
- DEVICE Baxter isolex 300i
Study Locations (1)
Maryland
- National Institute of Allergy and Infectious Diseases (NIAID) - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 1998-04 |
| Est. Completion | 2005-02 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001765
The ClinicalTrials.gov registry entry for NCT00001765 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 27-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (122% higher). 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 1 condition, with Chronic Granulomatous Disease appearing as the primary indexed condition, and to 2 interventions - of which Nexell Isolex with T-cell Depletion is the first listed.
NCT00001765 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001765 about?
NCT00001765 is a clinical study titled "Stem Cell Transplant Following Low-Intensity Chemotherapy to Treat Chronic Granulomatous Disease". This study will investigate the safety and effectiveness of a modified stem cell transplant procedure for treating chronic granulomatous disease (CGD) in patients with active infection. CGD is an inherited disorder of neutrophils-a type of infection-fighting white blood cell-that leaves patients vul...
What is the current status of trial NCT00001765?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 1998-04. Estimated completion is 2005-02.
What conditions does trial NCT00001765 study?
This clinical trial studies the following conditions: Chronic Granulomatous Disease.
What interventions are being tested in trial NCT00001765?
The interventions under investigation include: Nexell Isolex with T-cell Depletion (DEVICE), Baxter isolex 300i (DEVICE).
Who is sponsoring clinical trial NCT00001765?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001765 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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