Clinical Trial: A Phase II Trial of Low-Dose Interleukin-2 (IL-2) Added to Extra-Corporeal Photopheresis for Steroid-Refractory Chronic Graft-versus-Host-Disease

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 chroni
Sponsor: Dana-Farber Cancer Institute

Current Primary Outcome: Change in Clinical cGVHD Invovlement from Baseline to Week 8 and Week 16 [ Time Frame: Baseline, Week 8, and Week 16 ]

Participants will have their cGVHD evaluated at baseline, Week 8, and Week 16.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
  • Change in Regulatory T cell counts during ECP plus low-dose daily SC IL-2 [ Time Frame: Baseline through Week 16 of the study ]
  • Prednisone use during ECP plus low-dose IL-2 [ Time Frame: Baseline through Week 16 of the study ]
  • Overall survival [ Time Frame: From the start of treatment to 1 Year ]
  • Progression-free survival [ Time Frame: From the start of treatment to 1 Year ]
  • Non-relapse mortality [ Time Frame: From the start of treatment to 1 Year ]
  • Relapse at 1 year [ Time Frame: From the start of treatment to 1 Year ]


Original Secondary Outcome: Same as current

Information By: Dana-Farber Cancer Institute

Dates:
Date Received: January 7, 2015
Date Started: February 2015
Date Completion: April 2018
Last Updated: July 7, 2016
Last Verified: July 2016