A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory cGVHD
NCT02340676 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2026-02-20
Summary
This research study is evaluating a combination of a therapy called Extra-corporeal Photopheresis (ECP) with a drug called Interleukin-2 (IL-2) as a possible treatment for chronic graft-versus-host-disease (GVHD) following allogeneic stem cell transplant.
Conditions
- Chronic Graft-versus-host-disease
Interventions
- PROCEDURE
-
Extracorporeal Photopheresis (ECP)
Participants receive ECP treatment twice a week for 16 weeks
- DRUG
-
Interleukin-2
Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
Sponsors & Collaborators
-
Prometheus Laboratories
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
John Koreth, MBBS,D.Phil · Dana-Farber Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-02-28
- Primary Completion
- 2017-08-31
- Completion
- 2025-09-30
Countries
- United States
Study Locations
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