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NCT02143830 · ClinicalTrials.gov registry record · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
A Phase 2 study of Myelodysplastic Syndrome (MDS) and Fanconi Anemia, sponsored by Children's Hospital Medical Center, Cincinnati.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 70
- Enrollment target
- 3
- Study locations
NCT02143830: Recruiting Phase 2 study of Myelodysplastic Syndrome (MDS) and Fanconi Anemia, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT02143830 is a Phase 2 study of Myelodysplastic Syndrome (MDS) and Fanconi Anemia that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 70 participants, below the 82-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (15% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02143830, a Phase 2 study of Myelodysplastic Syndrome (MDS) and Fanconi Anemia, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 70 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to determine whether the use of lower doses of busulfan and the elimination of cyclosporine will further reduce transplant-related side effects for patients with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or matched unrelated donors following a preparative regimen of busulfan, fludarabine, anti-thymocyte globulin and cyclophosphamide.
Primary Outcome
Primary non-engraftment is diagnosed when the patient fails to achieve an ANC \>=500/mm3 at any time in the first 28 days post-transplant. If (1) after achievement of an absolute neutrophil count (ANC) \>=500/mm3, the ANC declines to \<500/mm3 for more than 3 consecutive days in the absence of relapse, or, (2) there is absence of donor cells in the marrow and/or blood as demonstrated by chimerism assay in the absence of relapse, a diagnosis of secondary graft failure is made. The patient is not
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- DRUG G-CSF
- DRUG rabbit ATG
Study Locations (3)
New York
- Memorial Sloan Kettering Cancer Center - New York
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Washington
- Fred Hutchinson Cancer Research Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2014-04 |
| Est. Completion | 2028-12 |
| Phase | Phase 2 |
What NCT02143830 shows while recruiting
NCT02143830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, below the 82-participant average among 19 other Myelodysplastic Syndrome (MDS) trials with a reported enrollment target (15% lower).
The record links to 4 conditions, with Myelodysplastic Syndrome (MDS) appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT02143830 reports a single indexed study location in New York, Ohio, Washington.
Frequently Asked Questions
What is clinical trial NCT02143830 about?
NCT02143830 is a clinical study titled "HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy". The purpose of this study is to determine whether the use of lower doses of busulfan and the elimination of cyclosporine will further reduce transplant-related side effects for patients with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or matched unrelated do...
What is the current status of trial NCT02143830?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 70 participants. The study started on 2014-04. Estimated completion is 2028-12.
What conditions does trial NCT02143830 study?
This clinical trial studies the following conditions: Myelodysplastic Syndrome (MDS), Fanconi Anemia, Acute Myelogenous Leukemia (AML), Severe Marrow Failure.
What interventions are being tested in trial NCT02143830?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), G-CSF (DRUG), rabbit ATG (DRUG).
Who is sponsoring clinical trial NCT02143830?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02143830 being conducted?
This trial has 3 study locations across New York, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02143830's enrollment target sits among peer trials
70 6th of 19 higher than 14 of 19 other Myelodysplastic Syndrome (MDS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myelodysplastic Syndrome (MDS) 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.
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