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Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT
NCT01962415 · View on ClinicalTrials.gov ↗
Study Summary
The objective of this study is to evaluate the efficacy of using a reduced-intensity condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT, matched unrelated donor (MUD) bone marrow transplant (BMT) or peripheral blood stem cell transplant (PBSCT) in patients with non-malignant disorders that are amenable to treatment with hematopoietic stem cell transplant (HSCT). After transplant, subjects will be followed for late effects and for ongoing graft success.
Conditions Studied
Interventions
- DRUG Fludarabine
- DRUG Melphalan
- DRUG Alemtuzumab
- DRUG Hydroxyurea
- DRUG Thiotepa
Study Locations (1)
Pennsylvania
- UPMC Children's Hospital of Pittsburgh — Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2014-02-04 |
| Est. Completion | 2027-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01962415
The ClinicalTrials.gov registry entry for NCT01962415 describes a study currently listed as recruiting. 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 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Paul Szabolcs, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 7 conditions, with Juvenile Rheumatoid Arthritis (JRA) appearing as the primary indexed condition, and to 5 interventions — of which Fludarabine 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: NCT01962415 reports 1 study location spanning 1 distinct geographic area — top geographies include Pennsylvania. 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 NCT01962415 about?
NCT01962415 is a clinical study titled "Reduced Intensity Conditioning for Non-Malignant Disorders Undergoing UCBT, BMT or PBSCT". The objective of this study is to evaluate the efficacy of using a reduced-intensity condition (RIC) regimen with umbilical cord blood transplant (UCBT), double cord UCBT, matched unrelated donor (MUD) bone marrow transplant (BMT) or peripheral blood stem cell transplant (PBSCT) in patients with non...
What is the current status of trial NCT01962415?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 100 participants. The study started on 2014-02-04. Estimated completion is 2027-11.
What conditions does trial NCT01962415 study?
This clinical trial studies the following conditions: Juvenile Rheumatoid Arthritis (JRA), Primary Immunodeficiency (PID), Congenital Bone Marrow Failure Syndromes, Inherited Metabolic Disorders (IMD), Hereditary Anemias. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01962415?
The interventions under investigation include: Fludarabine (DRUG), Melphalan (DRUG), Alemtuzumab (DRUG), Hydroxyurea (DRUG), Thiotepa (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01962415?
This trial is sponsored by Paul Szabolcs, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01962415 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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