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NCT02226861 · ClinicalTrials.gov registry record · Phase 1
Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation
A Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT02226861 is a Phase 1 study that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 24 participants.
The verdict
NCT02226861, a Phase 1 study, has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
Background: \- Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: \- To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD. Eligibility: * Recipients: age 18 65, with certain bone marrow or lymphatic system diseases and an available family member with partial tissue match. * Donors: age 18 80. Design: * Recipients will be screened with medical history, physical exam, and many tests including blood and tissue tying. * Donors will be screened with medical history, physical exam, blood tests and tissue typing. * Recipients will stay in the hospital 3 6 weeks. * All participants will have apheresis. Blood is drawn from one arm, run through a machine that collects white blood cells, then returned into the other arm. * Recipients will have: * Intravenous (IV) line placed under the skin and into a neck vein, to stay throughout transplant and recovery. They may also have a catheter inserted for collecting immune cells. * Bone marrow sample taken by needle. They will have 3 more after transplant. * Donors will have: * Filgrastim injected once daily for 5 6 days. * Stem and immune cells collected by another apheresis. * Recipients will get: * Eight 30-minute doses of radiation, sitting at a machine. * Donor immune cells by IV, 6 days before the transplant day. * Chemotherapy drugs by IV. \<TAB\>\<TAB\>- Donor stem cells by IV on transplant day. * After transplant, recipients will give self-injections of very low doses of Interleukin-2 once daily for about 12 weeks. * Before and after transplant, recipients will get medicine to suppress the immune system and antibiotics to prevent infections * Recipients must stay near NIH for 3 6 months after transplant. * All recipients and donors will have 3 years of follow-up.
Interventions
- DEVICE CliniMACS CD34 selection system
- BIOLOGICAL ULD IL-2
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2014-08-26 |
| Est. Completion | 2018-06-27 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02226861
The ClinicalTrials.gov registry entry for NCT02226861 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Heart, Lung, and Blood Institute (NHLBI), which has 501 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which CliniMACS CD34 selection system is the first listed.
NCT02226861 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02226861 about?
NCT02226861 is a clinical study titled "Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation". Background: \- Stem cell transplantation from a partially matched donor can lead to graft-versus-host disease (GVHD). Researchers want to learn how to improve these transplantations. Objective: \- To see if very low doses of Interleukin-2 after a partially matched transplantation prevent GVHD. E...
What is the current status of trial NCT02226861?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2014-08-26. Estimated completion is 2018-06-27.
What interventions are being tested in trial NCT02226861?
The interventions under investigation include: CliniMACS CD34 selection system (DEVICE), ULD IL-2 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02226861?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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