ECP + Low-Dose IL-2 for Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

Overseen byJohn Koreth, MBBS,D.Phil

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

John Koreth, MBBS,D.Phil

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for adults over 18 with chronic graft-versus-host-disease (cGVHD) after a stem cell transplant from a closely matched donor. They must have cGVHD that hasn't improved with steroids, stable medication use for the past month, and good organ function. Pregnant women, those with certain blood disorders or infections, recent ECP therapy or exposure to new immunosuppressants can't participate.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

You are expected to live for more than 3 months.

I am 18 years old or older.

See 7 more

Exclusion Criteria

I am currently taking calcineurin inhibitors and sirolimus.

I need more than 1 mg/kg/day of prednisone.

I have a history of blood clotting disorders.

See 14 more

Treatment Details

Interventions

Extracorporeal Photopheresis (ECP) (Procedure)
Interleukin-2 (Cytokine)

Trial OverviewThe study is testing if adding low-dose Interleukin-2 (IL-2) to Extra-corporeal Photopheresis (ECP), a light-based treatment, can help treat cGVHD better than ECP alone. Participants will receive both treatments and be monitored to see how well they respond compared to their condition before starting the trial.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: ECP plus IL-2Experimental Treatment2 Interventions

* Extracorporeal Photopheresis (ECP) standard-of-care * Daily subcutaneous (SC) interleukin-2 (IL-2) (Proleukin®) during predetermined weeks of treatment cycle