Your session is about to expire
← Back to Search
ECP + Low-Dose IL-2 for Graft-versus-Host Disease
Phase 2
Waitlist Available
Led By John Koreth, MBBS,D.Phil
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Recipients of 7-8/8 HLA matched adult donor allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
Participants must have steroid-refractory cGVHD. Steroid-refractory cGVHD is defined as having persistent signs and symptoms of cGVHD despite the use of prednisone at ≥ 0.25 mg/kg/day (or 0.5 mg/kg every other day) for at least 4 weeks without complete resolution of signs and symptoms
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from the start of treatment to 1 year
Awards & highlights
Study Summary
This trial is testing whether ECP + IL-2 is effective in treating GVHD after stem cell transplant.
Who is the study for?
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.Check my eligibility
What is being tested?
The 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.See study design
What are the potential side effects?
Possible side effects include reactions related to IL-2 such as chills, fever, fatigue; and ECP-related issues like dizziness or nausea during the procedure. There may also be risks associated with combining these treatments which will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I received a stem cell transplant that was a close match to my tissue type.
Select...
My chronic GVHD hasn't improved despite taking steroids for 4 weeks.
Select...
I can take care of myself and am up and about more than half of the day.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from the start of treatment to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from the start of treatment 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
Percentage of Participant With Response at Week 16
Secondary outcome measures
Non-relapse Mortality
Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy
Overall Survival
+4 moreSide effects data
From 2014 Phase 2 trial • 13 Patients • NCT01105650100%
Neutropenic fever
100%
Chills
100%
Dyspnea
100%
Edema
67%
Hypotension
67%
Death NOS
67%
Fever
67%
Hypertension
67%
Hypoxia
33%
Dizziness
33%
Double vision
33%
Acute kidney injury
33%
Blurred vision
33%
Foot pain
33%
Atrial fibrillation
33%
Vestibular disorder
33%
Hearing loss
33%
Confusion/Disoriented
33%
Ascites
33%
Hearing impairmed
33%
Hallucinations
33%
Headache
33%
Rash/Desquamation
33%
Depressed level of consciousness
33%
Strange dreams
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2
Arm 1: CsA
Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Interleukin-2
1994
Completed Phase 3
~700
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,078 Previous Clinical Trials
340,847 Total Patients Enrolled
Prometheus LaboratoriesIndustry Sponsor
26 Previous Clinical Trials
4,771 Total Patients Enrolled
John Koreth, MBBS,D.PhilPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently taking calcineurin inhibitors and sirolimus.You are expected to live for more than 3 months.I am 18 years old or older.I need more than 1 mg/kg/day of prednisone.I have a history of blood clotting disorders.I haven't had ECP or rituximab therapy in the last 4 weeks.I do not have allergies or reactions to heparin or 8-MOP.I haven't taken new immune-suppressing drugs in the last 100 days.My corticosteroid dose has been the same for the last 4 weeks.I agree to use birth control during the study.I currently have an infection that isn't under control.You are unable to follow the IL-2 treatment schedule.I do not have uncontrolled heart pain or symptoms of heart failure.I have active hepatitis B or C.My cancer has returned after treatment.I haven't taken new immunosuppressive drugs in the last 4 weeks.I have received a donor lymphocyte infusion within the last 100 days.I am HIV-positive and on combination antiretroviral therapy.I received a stem cell transplant that was a close match to my tissue type.My liver, kidneys, lungs, bone marrow, and heart are all functioning well.My chronic GVHD hasn't improved despite taking steroids for 4 weeks.I can take care of myself and am up and about more than half of the day.I have received an organ transplant from another person.I haven't changed my immunosuppressive medications in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: ECP plus IL-2
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Interleukin-2 obtained clearance from the FDA?
"Interleukin-2 has been assigned a safety rating of 2, as this is a Phase 2 clinical trial. Data collected up to now suggests the drug may be safe for consumption; however, no efficacy results have yet been reported."
Answered by AI
What is the current enrollment size of this medical experiment?
"Currently, this investigation is not taking on new participants. The trial was initially published on February 1st 2015 and last modified July 5th 2022. If you are looking for alternative studies, there exist 169 clinical trials admitting patients with Graft versus Host Disease and 58 Interleukin-2 research programmes recruiting volunteers."
Answered by AI
Is this research actively seeking participants at present?
"As detailed on clinicaltrials.gov, this particular trial has concluded recruitment activities and is no longer accepting participants. The study was first published in February 2015 and last updated July 5th 2022; however, 227 other trials are still open for enrollment."
Answered by AI
Have any prior experiments been executed with Interleukin-2?
"Presently, there are 58 ongoing investigations into Interleukin-2 with 4 trials in their final phase. While a handful of these clinical experiments for Interleukin-2 take place in Boston, Massachusetts, 396 sites across the globe are running trials concerning this topic."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger