Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
Recruiting now · Phase 2
Conditions studied: Primary T-cell Immunodeficiency Disorders, Common Variable Immunodeficiency, Immune System Diseases, Autoimmune Lymphoproliferative, Lymphoproliferative Disorders
In brief
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.
Key facts
- Study ID
- NCT02579967
- Run by
- National Cancer Institute (NCI)
- People needed
- 354
- Starts
- 2015-11-19
- Expected to finish
- 2036-12-31
- Last updated by the study team
- 2026-08-07
Who can join
Age: 4 and older, up to 75. Sex: any. Healthy volunteers: accepted.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
- National Marrow Donor Program — Minneapolis, Minnesota, United States (enrolling)
Full record on ClinicalTrials.gov
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