CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 10 enrolled
Drug / intervention
Aldesleukin +3 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03007238
NCT03007238Phase 2Completed

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

City of Hope Medical Center·interventional·Posted Jan 2, 2017·Updated Apr 8, 2024

In Brief

A Phase 2 clinical trial evaluating Aldesleukin, Extracorporeal Photopheresis, and 2 other interventions for Chronic Graft Versus Host Disease. Completed, enrolled 10 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 2, 2017
Enrollment StartJan 18, 2017
Primary CompletionOct 16, 2018
Study CompletionJun 26, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 9.5 years ago

Interventions

Aldesleukinbiological

Given SC

Extracorporeal Photopheresisprocedure

Undergo ECP

Laboratory Biomarker Analysisother

Correlative studies

Quality-of-Life Assessmentother

Ancillary studies