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NCT03663933 · ClinicalTrials.gov registry record · Phase 2
Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation
A Phase 2 study of Immune System Diseases and Lymphoproliferative Disorders, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 2
- Study locations
NCT03663933: Active Phase 2 study of Immune System Diseases and Lymphoproliferative Disorders, sponsored by National Cancer Institute (NCI).
NCT03663933 is a Phase 2 study of Immune System Diseases and Lymphoproliferative Disorders that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 71 participants, below the 149-participant average among 18 other Immune System Diseases trials with a reported enrollment target (52% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03663933, a Phase 2 study of Immune System Diseases and Lymphoproliferative Disorders, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 2
- Study locations
Study Summary
Background: Blood stem cells in the bone marrow make all the cells to normally defend a body against disease. Allogeneic blood or marrow transplant is when these stem cells are transferred from one person to another. Researchers think this treatment can provide a new, healthy immune system to correct T-cell problems in some people. Objective: To see if allogeneic blood or bone marrow transplant is safe and effective in treating people with T-cell problems. Eligibility: Donors: Healthy people ages 4 and older Recipients: People the same age with abnormal T-cell function causing health problems Design: All participants will be screened with: * Medical history * Physical exam * Blood, heart, and urine tests Donors will also have an electrocardiogram and chest x-ray. They may have veins tested or a pre-anesthesia test. Recipients will also have lung tests. Some participants will have scans and/or bone marrow collected by needle in the hip bones. Donors will learn about medicines and activities to avoid and repeat some screening tests. Some donors will stay in the hospital overnight and have bone marrow collected with anesthesia. Other donors will get shots for several days to stimulate cells. They will have blood removed by plastic tube (IV) in an arm vein. A machine will remove stem cells and return the rest of the blood to the other arm. Recipients will have: * More bone marrow and a small fragment of bone removed * Dental, diet, and social worker consultations * Scans * Chemotherapy and antibody therapy for 2 weeks * Catheter inserted in a chest or neck vein to receive donor stem cells * A hospital stay for several weeks with more medicines and procedures * Multiple follow-up visits
Primary Outcome
Percentage of recipients with \> 50% donor T cell chimerism and without death or graft failure. A graft failure event is defined as either primary or secondary graft failure, in the absence of a recurrent marrow malignancy.
Conditions Studied
Interventions
- DRUG GVHD Prophylaxis
- DRUG e-ATG
- PROCEDURE Immunosuppression Only Conditioning
- PROCEDURE Reduced Intensity Conditioning
- PROCEDURE Allogeneic HSC
Study Locations (2)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Minnesota
- National Marrow Donor Program - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-09-04 |
| Est. Completion | 2030-04-03 |
| Phase | Phase 2 |
What the registry record for NCT03663933 still lists
NCT03663933 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 149-participant average among 18 other Immune System Diseases trials with a reported enrollment target (52% lower).
The record links to 5 conditions, with Immune System Diseases appearing as the primary indexed condition, and to 5 interventions - of which GVHD Prophylaxis is the first listed.
NCT03663933 reports a single indexed study location in Maryland, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03663933 about?
NCT03663933 is a clinical study titled "Allogeneic Hematopoietic Cell Transplantation for Disorders of T-cell Proliferation and/or Dysregulation". Background: Blood stem cells in the bone marrow make all the cells to normally defend a body against disease. Allogeneic blood or marrow transplant is when these stem cells are transferred from one person to another. Researchers think this treatment can provide a new, healthy immune system to corre...
What is the current status of trial NCT03663933?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2018-09-04. Estimated completion is 2030-04-03.
What conditions does trial NCT03663933 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 NCT03663933?
The interventions under investigation include: GVHD Prophylaxis (DRUG), e-ATG (DRUG), Immunosuppression Only Conditioning (PROCEDURE), Reduced Intensity Conditioning (PROCEDURE), Allogeneic HSC (PROCEDURE).
Who is sponsoring clinical trial NCT03663933?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03663933 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
Similar trials for Immune System Diseases
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 NCT03663933's enrollment target sits among peer trials
71 7th of 18 higher than 12 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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