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Immunomodulator
Photopheresis + Aldesleukin for Chronic Graft-Versus-Host Disease
Phase 2
Waitlist Available
Led By Amandeep Salhotra, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of first dose of study drug to date of death from any cause, assessed up to 1 year
Awards & highlights
Study Summary
This trial is testing a new treatment for chronic graft-versus-host disease that involves removing and treating a patient's blood with ultraviolet light and drugs, then returning it to the patient. The goal is to increase T-reg cells in patients with cGVHD.
Who is the study for?
This trial is for patients with chronic graft-versus-host disease that's not getting better with steroids. They must be on a stable steroid dose, have had an allogeneic stem cell transplant, and agree to use contraception. People can't join if they've used certain treatments recently, have uncontrolled illnesses or infections, HIV, are pregnant or breastfeeding, or have other active cancers.Check my eligibility
What is being tested?
The study tests extracorporeal photopheresis (blood treated with light) and low-dose Aldesleukin (boosts white blood cells) in patients whose bodies are attacking their own tissues after a stem cell transplant. The goal is to see if these treatments increase T-reg cells which help control the immune system.See study design
What are the potential side effects?
Possible side effects include reactions related to boosting the immune system such as fever and chills. There might also be risks associated with handling blood outside of the body like infection or clotting during photopheresis.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of first dose of study drug to date of death from any cause, assessed up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of first dose of study drug to date of death from any cause, assessed up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate at Week 16 (4 Weeks After the End of Treatment)
Secondary outcome measures
Failure-free Survival
Overall Survival
Trial Design
1Treatment groups
Experimental Treatment
Group I: Supportive care (aldesleukin and ECP)Experimental Treatment4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Extracorporeal Photopheresis
2004
Completed Phase 2
~40
Aldesleukin
2012
Completed Phase 4
~1620
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,606 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,353 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Amandeep Salhotra, MDPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You had a donor lymphocyte infusion within the last 100 days before joining the study.You have taken any new medication that weakens your immune system in the last 4 weeks before joining the study.You should not have any serious illness or active infection. If you are currently taking a high dose of prednisone, you will not be able to participate.Your platelet count is higher than 50,000 per cubic millimeter.You have a history of specific blood disorders that involve clotting and damage to red blood cells.You currently have a recurring cancer.If you have HIV and are taking medicine for it, you cannot participate.You have had allergic reactions to drugs similar to IL-2.Your total bilirubin level is less than 2.0 mg/dl, unless you have Gilbert's syndrome.You cannot have any other cancer that is currently growing, except for certain types of skin cancer.You have received a specific type of stem cell transplant, except for certain alternative donor transplants.Patients with ongoing chronic GVHD that needs medication are allowed to participate.You still have signs and symptoms of cGVHD even after using prednisone for at least 4 weeks without complete improvement.You are generally able to perform daily activities and take care of yourself.You are expected to live for more than 3 months.Your liver enzymes (AST and ALT) should not be more than twice the upper limit of normal, unless your liver problems are related to a specific condition called cGVHD.If your liver function tests are abnormal due to a specific medical condition called cGVHD and your doctor confirms it, you may still be allowed to participate.Your kidney function is within the normal range or your creatinine clearance is higher than 60 mL/min/1.73 m^2 if your creatinine levels are higher than normal.Your white blood cell count is higher than 1000 per cubic millimeter.You have chronic graft-versus-host disease that hasn't responded to steroids and have tried multiple other treatments. You can have had a treatment called ECP before, but not IL-2.You have severe chest pain or heart failure symptoms that are not under control.
Research Study Groups:
This trial has the following groups:- Group 1: Supportive care (aldesleukin and ECP)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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