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Cytokine
IL-2 for Chronic Graft-versus-Host Disease
Phase 2
Waitlist Available
Led By John Koreth, MBBS, DPhil
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
Recipient of allogeneic stem cell transplantation with myeloablative or non-myeloablative conditioning regimens
No more than 2 prior lines of cGVHD therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years from start of il-2
Awards & highlights
Study Summary
This trial is testing whether IL-2 can help control chronic GVHD by stopping the donor's immune system from 'rejecting' the patient's body.
Who is the study for?
This trial is for people who have chronic graft-versus-host disease (cGVHD) after a stem cell transplant and haven't responded to steroids. They should have started systemic therapy within the last 6 months, had no more than two prior cGVHD treatments, and must have good organ function. It's not for those with HIV on antiretrovirals, active hepatitis B or C, certain drug combinations, cancer relapse, uncontrolled infections or heart issues.Check my eligibility
What is being tested?
The study tests Interleukin-2 (IL-2) combined with steroids in treating cGVHD. Researchers want to see if IL-2 can prevent the donor's immune system from attacking the recipient's body by controlling this rejection process known as cGVHD.See study design
What are the potential side effects?
While specific side effects of IL-2 in this context aren't listed here, generally IL-2 can cause symptoms like fatigue, feverish feelings, weight gain due to fluid retention and at times it may affect how your organs work.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have received a stem cell transplant from a donor.
Select...
I have had 2 or fewer treatments for chronic GVHD.
Select...
My chronic GVHD hasn't improved with steroids, started treatment within the last 6 months.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years from start of il-2
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years from start of il-2
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 of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD
Secondary outcome measures
Immunologic Effects of Low-dose Daily SC IL-2: Treg Cell Counts
Immunologic Effects of Low-dose Daily SC IL-2: Treg/Tcon Ratio
Overall Survival and Progression-free Survival
+2 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%
Double vision
33%
Dizziness
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: Interleukin-2Experimental Treatment1 Intervention
Each study participant will receive daily subcutaneous IL-2 (1 x 106 IU/m2/day) for self-administration for 12 weeks, followed by a 4-week hiatus. IL-2 will be typically administered on an outpatient basis. After completing the 16 week study (12 weeks of IL-2 study treatment and a mandatory 4 weeks off-IL-2), patients experiencing clinical benefit (complete or partial response; as well as minor response not meeting NIH criteria for partial response) with an acceptable toxicity profile will be permitted to continue extended-duration treatment indefinitely at the discretion of the treating physician.
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
340,837 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,118 Total Patients Enrolled
1 Trials studying Graft-versus-Host Disease
236 Patients Enrolled for Graft-versus-Host Disease
Prometheus LaboratoriesIndustry Sponsor
26 Previous Clinical Trials
4,761 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I take more than 1 mg/kg/day of prednisone or its equivalent.I am currently taking calcineurin inhibitors and sirolimus.I have received a stem cell transplant from a donor.I have had 2 or fewer treatments for chronic GVHD.I do not have uncontrolled heart pain or symptoms of heart failure.I am HIV-positive and on combination antiretroviral therapy.I have a history of blood clotting disorders.I have an infection that is not under control.You have an ongoing hepatitis B or C infection.My chronic GVHD hasn't improved with steroids, started treatment within the last 6 months.My organs are working well.I have received an organ transplant from another person.You are expected to live for more than 3 months.My cancer has returned after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Interleukin-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.
How many participants can the maximum capacity of this research accommodate?
"This trial has already concluded recruitment. Initially posted on July 1st 2011, the last update was made in July 5th 2022. As an alternative, there are currently 169 trials for Graft-Versus-Host Disease and 24 clinical studies involving Interleukin-2 that require participants right now."
Answered by AI
What prior research has been explored concerning Interleukin-2?
"Presently, 24 clinical trials concerning Interleukin-2 are being conducted. None of these experiments have reached Phase 3; however, 70 different sites located in Meldola FC are running tests for this particular therapy."
Answered by AI
What potential adverse effects could arise from the usage of Interleukin-2?
"Based on the available evidence, our team at Power gave Interleukin-2 a rating of 2 due to its status as being in Phase 2 clinical trials – meaning that although it has been shown to be safe, there is no data confirming efficacy."
Answered by AI
Does this research introduce any new insights?
"As of now, 24 independent studies regarding Interleukin-2 are taking place across 45 cities and 10 nations. This research was kickstarted in 2006 by Key Biologics LLC with a Phase 2 trial involving 1230 patients. Sixty trials have been conducted since then."
Answered by AI
Is enrollment in this experiment still available to volunteers?
"This medical trial is no longer actively seeking participants. It was posted on July 1st, 2011 and last updated five days ago. Patients looking for alternative studies may have luck with 169 trials currently recruiting individuals dealing with graft vs host disease or 24 clinical studies that are still searching specifically for Interleukin-2 patients."
Answered by AI
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