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NCT02579967 · ClinicalTrials.gov registry record · Phase 2
Pilot Trial of Allogeneic Blood or Marrow Transplantation for Primary Immunodeficiencies
A Phase 2 study of Immune System Diseases and Lymphoproliferative Disorders, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 354
- Enrollment target
- 2
- Study locations
NCT02579967: Recruiting Phase 2 study of Immune System Diseases and Lymphoproliferative Disorders, sponsored by National Cancer Institute (NCI).
NCT02579967 is a Phase 2 study of Immune System Diseases and Lymphoproliferative Disorders that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 354 participants, above the 133-participant average among 18 other Immune System Diseases trials with a reported enrollment target (166% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02579967, a Phase 2 study of Immune System Diseases and Lymphoproliferative Disorders, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 354 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Proportion of participants without GVHD
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 |
What NCT02579967 shows while recruiting
NCT02579967 is an interventional study that assigns participants to a tested intervention. The registered 354 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 18 other Immune System Diseases trials with a reported enrollment target (166% higher).
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.
NCT02579967 reports a single indexed study location in Maryland, Minnesota.
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.
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).
Who is sponsoring clinical trial NCT02579967?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02579967's enrollment target sits among peer trials
354 3rd of 18 higher than 16 of 18 other Immune System Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Immune System Diseases 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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