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NCT02282904 · ClinicalTrials.gov registry record · Phase 1
Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide
A Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 1
- Development phase
- 7
- Enrollment target
NCT02282904: Clinical Trial Phase 1 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT02282904 is a Phase 1 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 7 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02282904, a Phase 1 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 7 participants
- Enrollment target
Study Summary
Background: \- Chronic Granulomatous Disease (CGD) causes immune system problems. Treatment is usually a bone marrow transplant from a fully matched donor. Researchers want to try using partially matched donors for patients who do not have a fully matched donor available. The researchers will also use the drug cyclophosphamide to try to improve the outcomes when using a partially matched donor. Objective: \- To learn the effectiveness of using cyclophosphamide with a transplant from a partially matched donor in treating CGD. Eligibility: \- Recipients: age 2-65 with CGD with an ongoing infection that has not been cured by standard treatment and no fully matched donor available in an appropriate timeframe. Design: * Recipients will: * be admitted to the hospital 2 weeks before transplant. * be screened with blood and urine tests, breathing and heart health tests, X-rays, and/or magnetic resonance imaging. They may have a bone marrow aspiration and biopsy. * meet with a social worker and dentist. * get chemotherapy, radiation, and other medicines. * get an intravenous (IV) catheter in their chest. * have the transplant. * get more medicines and standard supportive care. * have blood drawn frequently. * have to stay in the Washington, D.C. area for 3 months post-transplant. * be followed closely for the first 6 months, and then less frequently for at least 5 years.
Primary Outcome
Patient will have donor chimerism of greater than 20% and resolution of infection or autoimmunity at end of follow up
Interventions
- DRUG Cyclophosphamide
- DRUG Sirolimus
- BIOLOGICAL Donor peripheral blood stem cells.
- DRUG Cyclophosphamide post transplant
- RADIATION Total body 200cGy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2014-10-23 |
| Est. Completion | 2019-12-10 |
| Phase | Phase 1 |
Why NCT02282904 stopped before completion
NCT02282904 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02282904 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02282904 about?
NCT02282904 is a clinical study titled "Haploidentical Transplant for People With Chronic Granulomatous Disease Using Post Transplant Cyclophosphamide". Background: \- Chronic Granulomatous Disease (CGD) causes immune system problems. Treatment is usually a bone marrow transplant from a fully matched donor. Researchers want to try using partially matched donors for patients who do not have a fully matched donor available. The researchers will also ...
What is the current status of trial NCT02282904?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 7 participants. The study started on 2014-10-23. Estimated completion is 2019-12-10.
What interventions are being tested in trial NCT02282904?
The interventions under investigation include: Cyclophosphamide (DRUG), Sirolimus (DRUG), Donor peripheral blood stem cells. (BIOLOGICAL), Cyclophosphamide post transplant (DRUG), Total body 200cGy (RADIATION).
Who is sponsoring clinical trial NCT02282904?
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
How this trial's enrollment target compares
Where NCT02282904's enrollment target sits among peer trials
7 1972nd of 2000 higher than 27 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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