NCT03007238

Extracorporeal Photopheresis and Low Dose Aldesleukin in Treating Patients With Steroid Refractory Chronic Graft-Versus-Host Disease

Phase II Trial of Extracorporeal Photopheresis (ECP) Plus Low Dose IL-2 for Treatment of Steroid Refractory Chronic Graft-versus-Host Disease (cGVHD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies efficacy of extracorporeal photopheresis and low dose aldesleukin (interleukin-2) in treating patients with chronic graft-versus-host disease (cGVHD) that does not respond to upfront treatment with steroids. In graft-vs-host disease, patients have a small quantity of a white blood cell called T regulatory cells or T-reg cells that helps to control the immune system. Extracorporeal photopheresis is a procedure where patient's blood is removed and treated with ultraviolet light and drugs that become active when exposed to light. The treated blood is then returned to the patient and may be effective in increasing T-reg cells in patients with cGVHD. Aldesleukin increases the activity and growth of white blood cells, and it has shown to enhance T-reg cells in patients with cGVHD and may be effective improving GVHD symptoms.

Detailed description

PRIMARY OBJECTIVES: I. To evaluate the anti-cGVHD activity of extracorporeal photopheresis (ECP) when combined with low dose IL-2 (interleukin 2) (aldesleukin), in patients with steroid refractory cGVHD, as assessed by overall cGVHD response rate (complete response \[CR\]+partial response \[PR\]+stable disease \[SD\]). SECONDARY OBJECTIVES: I. Characterize and evaluate toxicities, including type, frequency, severity, attribution, time course and duration. II. Estimate overall and failure-free survival, non-relapse mortality (NRM) and relapse, through 1 year after initiation of treatment. III. Characterize chronic GVHD Symptom Scale scores -self-report (with assistance from register nurses \[RNs\] and medical doctors \[MDs\]). IV. Assess the immunologic effects of low-dose daily subcutaneous (SC) IL-2 + ECP. V. Correlate clinical endpoints of response with ECP performance parameters. OUTLINE: Patients receive aldesleukin subcutaneously (SC) daily for 12 weeks. Patients also undergo ECP twice weekly on weeks 1-4 and then receive 2 ECP treatments every 2 weeks on weeks 5-12. Patients responding to upfront therapy with aldesleukin and ECP have the option to continue combination therapy per the discretion of the treating physician until clinical benefit is maintained or toxicities develop. After completion of study treatment, patients are followed up periodically.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Aldesleukin	Given SC
PROCEDURE	Extracorporeal Photopheresis	Undergo ECP
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Quality-of-Life Assessment	Ancillary studies

Timeline

• Start date: 2017-01-18
• Primary completion: 2018-10-16
• Completion: 2019-06-26
• First posted: 2017-01-02
• Last updated: 2024-04-08
• Results posted: 2024-04-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study