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NCT03910452 · ClinicalTrials.gov registry record · Early Phase 1
Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide
A Early Phase 1 study of Chronic Granulomatous Disease, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Active
- Registry status
- Early Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT03910452 is a Early Phase 1 study of Chronic Granulomatous Disease that is active but no longer recruiting, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 4 participants, below the 33-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03910452, a Early Phase 1 study of Chronic Granulomatous Disease, is active but no longer recruiting, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: CGD causes infections and inflammation. The only cure currently is a bone marrow transplant. Most often a perfectly matched bone marrow donor is used. Researchers want to see if they can lower the risks of using a mismatched donor. Objectives: To see if it is safe to use a related bone marrow donor who is only a partial match to a person with CGD. To see how well drugs given to a person before and after transplant help the body accept the transplant. Eligibility: People ages 4-65 with CGD for whom stem cell transplant may be a cure and who do not have a perfectly matched donor, related or unrelated. Design: Participants will be screened with: Medical history Physical exam Blood tests Participants will be admitted to the hospital about 2 weeks before the transplant. They will have blood, urine, breathing, and heart tests. They may have CT and/or MRI scans. They will have a needle inserted into their hipbone to remove marrow. They will have dental, neurologic, and psychologic tests. They will have a central catheter placed: A line will be placed into a vein in their upper chest. They will get drugs, chemotherapy, and radiation to prepare for the transplant. Participants will receive the donated cells through their catheter. The cells will be from one of their relatives. Participants will stay in the hospital about 6 weeks after the transplant. After they leave the hospital, participants will have to stay in the area with visits about 2 times a week for approximately 100 days post transplant. Then visits will be every 3 to 6 months for 2 years. Then visits will be once a year....
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Sirolimus
- DRUG Busulfan
- DRUG Alemtuzumab
- RADIATION Total Body Irradiation
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2019-10-28 |
| Est. Completion | 2034-06-15 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03910452
The ClinicalTrials.gov registry entry for NCT03910452 describes a study currently listed as active not recruiting, categorized as Early Phase 1. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 33-participant average among 10 other Chronic Granulomatous Disease trials with a reported enrollment target (88% lower). 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 5 interventions - of which Cyclophosphamide is the first listed.
NCT03910452 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT03910452 about?
NCT03910452 is a clinical study titled "Haploidentical Transplant for People With Chronic Granulomatous Disease (CGD) Using Alemtuzumab, Busulfan and TBI With Post-Transplant Cyclophosphamide". Background: CGD causes infections and inflammation. The only cure currently is a bone marrow transplant. Most often a perfectly matched bone marrow donor is used. Researchers want to see if they can lower the risks of using a mismatched donor. Objectives: To see if it is safe to use a related bon...
What is the current status of trial NCT03910452?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 4 participants. The study started on 2019-10-28. Estimated completion is 2034-06-15.
What conditions does trial NCT03910452 study?
This clinical trial studies the following conditions: Chronic Granulomatous Disease.
What interventions are being tested in trial NCT03910452?
The interventions under investigation include: Cyclophosphamide (DRUG), Sirolimus (DRUG), Busulfan (DRUG), Alemtuzumab (DRUG), Total Body Irradiation (RADIATION).
Who is sponsoring clinical trial NCT03910452?
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 NCT03910452 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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