A Phase 2 interventional study of Aldesleukin and Extracorporeal Photopheresis in Chronic Graft Versus Host Disease, sponsored by City of Hope Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by City of Hope Medical Center · Phase 2, Interventional, and Treatment
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.
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.
376 studies on the registry are indexed under Bronchiolitis Obliterans Syndrome; 104 are open to participants now.
This study's enrollment of 10 is below the median of 35 across 296 interventional studies indexed under Bronchiolitis Obliterans Syndrome.
Browse Bronchiolitis Obliterans Syndrome studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive aldesleukin 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.
Biological: Aldesleukin · Procedure: Extracorporeal Photopheresis · Other: Laboratory Biomarker Analysis · Other: Quality-of-Life Assessment
Given SC
Also known as: 125-L-Serine-2-133-interleukin 2, Proleukin, r-serHuIL-2, Recombinant Human IL-2, Recombinant Human Interleukin-2
Undergo ECP
Also known as: Extracorporeal Photophoresis, photopheresis, Photophoresis
Correlative studies
Ancillary studies
Also known as: Quality of Life Assessment
Overall Response Rate at Week 16 (4 Weeks After the End of Treatment)
Defined as the proportion of response-evaluable participates that achieve a CR/PR or SD at Week 16 (4 weeks after the end of treatment).
Time frame: At Week 16 (4 weeks after the end of treatment)
Failure-free Survival
Failure-free survival will be estimated using the product-limit method of Kaplan and Meier.
Time frame: From date of first dose of study drug to first documented cGVHD progression (necessitating change of treatment), malignancy relapse or progression or death from any cause, whichever occurs first, assessed up to 1 year
Overall Survival
Overall survival was estimated using the product-limit method of Kaplan and Meier.
Time frame: From date of first dose of study drug to date of death from any cause, assessed up to 1 year
| Milestone | Overall Study |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
Defined as the proportion of response-evaluable participates that achieve a CR/PR or SD at Week 16 (4 weeks after the end of treatment).
| percentage of participants | Treatment (ECP+IL-2) |
|---|---|
| Overall response rate in patients who were alive at Week 16 (4 weeks after the end of treatment) | 88.9 (51.8 to 99.7) |
| Overall response rate by ITT | 80.0 (44.4 to 97.5) |
Failure-free survival will be estimated using the product-limit method of Kaplan and Meier.
| percentage of participants | Overall Study |
|---|---|
| Failure-free Survival | 40 (18.7 to 85.5) |
Overall survival was estimated using the product-limit method of Kaplan and Meier.
| percentage of participants | Overall Study |
|---|---|
| Overall Survival | 60 (36.2 to 99.5) |
Collected over Adverse events were assessed from date of first dose of study drug up to 16 weeks. All-Cause Mortality was assessed from first dose until death, assessed up to 1 year.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Overall Study | 4/10 (40%) | 3/10 (30%) | 8/10 (80%) |
| Event | Overall Study |
|---|---|
| SepsisInfections and infestations | 2/10 |
| Atrial flutterCardiac disorders | 1/10 |
| Bronchial infectionInfections and infestations | 1/10 |
| Event | Overall Study |
|---|---|
| AnemiaBlood and lymphatic system disorders | 3/10 |
| HyperglycemiaMetabolism and nutrition disorders | 2/10 |
| HypophosphatemiaMetabolism and nutrition disorders | 2/10 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 2/10 |
| HypertensionVascular disorders | 2/10 |
| Anal painGastrointestinal disorders | 1/10 |
| NauseaGastrointestinal disorders | 1/10 |
| Oral painGastrointestinal disorders | 1/10 |
| Non-cardiac chest painGeneral disorders | 1/10 |
| Catheter related infectionInfections and infestations | 1/10 |
10 participants
| Age, Continuous(years) | Treatment (ECP Plus Low Dose IL-2) |
|---|---|
| Median | 46 (22 to 66) |
| Sex: Female, Male(Participants) | Treatment (ECP Plus Low Dose IL-2) |
|---|---|
| Female | 6 |
| Male | 4 |
| Ethnicity (NIH/OMB)(Participants) | Treatment (ECP Plus Low Dose IL-2) |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 7 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Treatment (ECP Plus Low Dose IL-2) |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 8 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(participants) | Treatment (ECP Plus Low Dose IL-2) |
|---|---|
| United States | 10 |
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Bronchiolitis Obliterans Syndrome→
City of Hope Medical Center