Ultra-Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation
Public ClinicalTrials.gov record NCT02226861. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Ultra Low Dose IL-2 Therapy as GVHD Prophylaxis in Haploidentical Allogeneic Stem Cell Transplantation
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02226861
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 75 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Aug 25, 2014
- Primary completion
- May 22, 2018
- Completion
- Jun 26, 2018
- Last update posted
- Jul 4, 2018
2014 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02226861, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 4, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02226861 live on ClinicalTrials.gov.