A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory Chronic Graft-versus-Host-Disease
Procedure: Extracorporeal Photopheresis (ECP)
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory Chronic Graft-versus-Host-Disease|
- Change in Clinical cGVHD Invovlement from Baseline to Week 8 and Week 16 [ Time Frame: Baseline, Week 8, and Week 16 ] [ Designated as safety issue: No ]Participants will have their cGVHD evaluated at baseline, Week 8, and Week 16.
- Number of Grade 3 or higher Toxicities related to ECP plus low-dose SC IL-2 therapy [ Time Frame: Baseline through Week 16 of the study ] [ Designated as safety issue: Yes ]
- Change in Regulatory T cell counts during ECP plus low-dose daily SC IL-2 [ Time Frame: Baseline through Week 16 of the study ] [ Designated as safety issue: No ]
- Prednisone use during ECP plus low-dose IL-2 [ Time Frame: Baseline through Week 16 of the study ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: From the start of treatment to 1 Year ] [ Designated as safety issue: No ]
- Progression-free survival [ Time Frame: From the start of treatment to 1 Year ] [ Designated as safety issue: No ]
- Non-relapse mortality [ Time Frame: From the start of treatment to 1 Year ] [ Designated as safety issue: No ]
- Relapse at 1 year [ Time Frame: From the start of treatment to 1 Year ] [ Designated as safety issue: No ]
|Study Start Date:||February 2015|
|Estimated Study Completion Date:||February 2022|
|Estimated Primary Completion Date:||June 2018 (Final data collection date for primary outcome measure)|
Experimental: ECP plus IL-2
Procedure: Extracorporeal Photopheresis (ECP)
Participants receive ECP treatment twice a week for 16 weeksDrug: Interleukin-2
Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
This research study is a Phase II clinical trial. Phase II clinical trials test the safety and effectiveness of an investigational intervention to learn whether the intervention works in treating a specific disease. "Investigational" means that the intervention is being studied.
The FDA (the U.S. Food and Drug Administration) has not approved IL-2 for the treatment of chronic GVHD but it has been approved for metastatic renal cell carcinoma (MCC) and metastatic melanoma. ECP is a standard of care treatment for chronic GVHD that has not responded to steroids.
Chronic GVHD is a medical condition that may occur after receiving bone marrow, stem cell or cord blood transplant from a donor. The donor's immune system may recognize (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host disease.
Traditional standard therapy to treat chronic GVHD is prednisone (steroids). Participants on this trial have not responded to steroid therapy. The investigstors are looking to assess whether the combination of IL-2 and ECP therapy helps control chronic GVHD by stopping the donor's immune system from 'rejecting' the participant's body.
Participants will receive standard-of-care ECP treatment two times a week for 16 weeks. Each treatment will last approximately 2-3 hours. Starting after Week 8 of the ECP treatments, participants will give themselves or be given IL-2 through an injection under their skin. Participants will do this once every day for 8 weeks until the end of the 16-week ECP treatment. If a participant's GVHD worsens during the initial 8 weeks of ECP treatment, he or she has the option of starting IL-2 early.
If a participant's chronic GVHD improves at the end of the 16-week study duration, he or she may have the option of continuing the combination therapy of ECP and IL-2. Extended duration therapy is twice weekly ECP treatments plus daily IL-2 starting at the end of week 16. Participants may also have the option of continuing ECP treatments without IL-2 after the end of Week 16. If this is the case, participants will only be followed for one year from the start of therapy and will not have required study visits or tests.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02340676
|Contact: John Koreth, M.B.B.S.,D.Phil||617) 632-2949||JKORETH@PARTNERS.ORG|
|United States, Massachusetts|
|Dana-Farber Cancer Insitute||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: John Koreth, DPhil, MBBS 617-632-2949 email@example.com|
|Principal Investigator: John Koreth, MD|
|Principal Investigator:||John Koreth, M.B.B.S.,D.Phil||Dana-Farber Cancer Institute|