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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: Completed Phase 1 study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
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, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary endpoint to this study is to evaluate the safety of ULD IL-2 as GVHD prophylaxis in haploidentical transplantation.
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 |
What the finished NCT02226861 record still lists
NCT02226861 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 2 interventions - of which CliniMACS CD34 selection system is the first listed.
NCT02226861 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02226861's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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