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Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
NCT02579967 · View on ClinicalTrials.gov ↗
Study Summary
Background: Allogeneic blood or marrow transplant is when stem cells are taken from one person s blood or bone marrow and given to another person. Researchers think this may help people with immune system problems. Objective: To see if allogeneic blood or bone marrow transplant is safe and effective in treating people with primary immunodeficiencies. Eligibility: Donors: Healthy people ages 4 or older Recipients: People ages 4-75 with a primary immunodeficiency that may be treated with allogeneic blood or marrow transplant Design: Participants will be screened with medical history, physical exam, and blood tests. Participants will have urine tests, EKG, and chest x-ray. Donors will have: Bone marrow harvest: With anesthesia, marrow is taken by a needle in the hipbone. OR Blood collection: They will have several drug injections over 5-7 days. Blood is taken by IV in one arm, circulates through a machine to remove stem cells, and returned by IV in the other arm. Possible vein assessment or pre-anesthesia evaluation Recipients will have: Lung test, heart tests, radiology scans, CT scans, and dental exam Possible tissue biopsies or lumbar puncture Bone marrow and a small piece of bone removed by needle in the hipbone. Chemotherapy 1-2 weeks before transplant day Donor stem cell donation through a catheter put into a vein in the chest or neck Several-week hospital stay. They will take medications and may need blood transfusions and additional procedures. After discharge, recipients will: Remain near the clinic for about 3 months. They will have weekly visits and may require hospital readmission. Have multiple follow-up visits to the clinic in the first 6 months, and less frequently for at least 5 years.
Conditions Studied
Interventions
- DRUG Immunosuppression Only Conditioning -Closed with amendment L
- DRUG Reduced Intensity Conditioning
- DRUG Myeloablative Conditioning-Closed with amendment L
- DRUG GVHD Prophylaxis
- PROCEDURE Allo BMT
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center — Bethesda
Minnesota
- National Marrow Donor Program — Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 354 participants |
| Start Date | 2015-11-19 |
| Est. Completion | 2036-12-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02579967
The ClinicalTrials.gov registry entry for NCT02579967 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 354 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 5 conditions, with Immune System Diseases appearing as the primary indexed condition, and to 5 interventions — of which Immunosuppression Only Conditioning -Closed with amendment L 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: NCT02579967 reports 2 study locations spanning 2 distinct geographic areas — top geographies include Maryland, Minnesota. 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 NCT02579967 about?
NCT02579967 is a clinical study titled "Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies". Background: Allogeneic blood or marrow transplant is when stem cells are taken from one person s blood or bone marrow and given to another person. Researchers think this may help people with immune system problems. Objective: To see if allogeneic blood or bone marrow transplant is safe and effect...
What is the current status of trial NCT02579967?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 354 participants. The study started on 2015-11-19. Estimated completion is 2036-12-31.
What conditions does trial NCT02579967 study?
This clinical trial studies the following conditions: Immune System Diseases, Lymphoproliferative Disorders, Common Variable Immunodeficiency, Autoimmune Lymphoproliferative, Primary T-cell Immunodeficiency Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02579967?
The interventions under investigation include: Immunosuppression Only Conditioning -Closed with amendment L (DRUG), Reduced Intensity Conditioning (DRUG), Myeloablative Conditioning-Closed with amendment L (DRUG), GVHD Prophylaxis (DRUG), Allo BMT (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02579967?
This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02579967 being conducted?
This trial has 2 study locations across Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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