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Hematopoietic Stem Cell Transplant for Fanconi Anemia
NCT01071239 · View on ClinicalTrials.gov ↗
Study Summary
The trial proposed is a single arm phase II treatment protocol designed to examine engraftment, toxicity, graft-versus-host disease, and ultimate disease-free survival following a novel cytoreductive regimen including busulfan, cyclophosphamide and fludarabine and anti-thymocyte globulin (ATG- a non-chemotherapy drug whose role is to kill your immune system) for the treatment of patients with Fanconi anemia who have severe aplastic anemia (SAA), or myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), lacking HLA-genotypically identical donors using stem cell transplants derived from (1) HLA-compatible unrelated donors or (2) HLA haplotype-mismatched related donors.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Busulfan
- DRUG ATG
- DEVICE CliniMACs device
Study Locations (1)
Wisconsin
- Medical College of Wisconsin — Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2009-04 |
| Est. Completion | 2016-08-30 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01071239
The ClinicalTrials.gov registry entry for NCT01071239 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical College of Wisconsin, which has 614 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fanconi Anemia appearing as the primary indexed condition, and to 5 interventions — of which Cyclophosphamide is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01071239 reports 1 study location spanning 1 distinct geographic area — top geographies include Wisconsin. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01071239 about?
NCT01071239 is a clinical study titled "Hematopoietic Stem Cell Transplant for Fanconi Anemia". The trial proposed is a single arm phase II treatment protocol designed to examine engraftment, toxicity, graft-versus-host disease, and ultimate disease-free survival following a novel cytoreductive regimen including busulfan, cyclophosphamide and fludarabine and anti-thymocyte globulin (ATG- a non...
What is the current status of trial NCT01071239?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 1 participants. The study started on 2009-04. Estimated completion is 2016-08-30.
What conditions does trial NCT01071239 study?
This clinical trial studies the following conditions: Fanconi Anemia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01071239?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Busulfan (DRUG), ATG (DRUG), CliniMACs device (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01071239?
This trial is sponsored by Medical College of Wisconsin, which has 614 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01071239 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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