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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

Must not have

Ongoing prednisone requirement > 1 mg/kg/day (or equivalent)

Concurrent use of calcineurin-inhibitors plus sirolimus

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years from start of il-2

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I have received a stem cell transplant from a donor.

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I have had 2 or fewer treatments for chronic GVHD.

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My chronic GVHD hasn't improved with steroids, started treatment within the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I take more than 1 mg/kg/day of prednisone or its equivalent.

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I am currently taking calcineurin inhibitors and sirolimus.

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I do not have uncontrolled heart pain or symptoms of heart failure.

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I am HIV-positive and on combination antiretroviral therapy.

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I have a history of blood clotting disorders.

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I have an infection that is not under control.

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I have received an organ transplant from another person.

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My cancer has returned after treatment.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years from start of il-2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate of Low-dose Daily SC IL-2 in Steroid-refractory cGVHD

Secondary study objectives

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 more

Side effects data

From 2014 Phase 2 trial • 13 Patients • NCT01105650

100%

Neutropenic fever

100%

Chills

100%

Dyspnea

100%

Edema

67%

Hypotension

67%

Death NOS

67%

Fever

67%

Hypertension

67%

Hypoxia

33%

Ascites

33%

Blurred vision

33%

Hearing loss

33%

Double vision

33%

Confusion/Disoriented

33%

Vestibular disorder

33%

Dizziness

33%

Atrial fibrillation

33%

Acute kidney injury

33%

Foot pain

33%

Hearing impairmed

33%

Hallucinations

33%

Headache

33%

Rash/Desquamation

33%

Depressed level of consciousness

33%

Strange dreams

100%

80%

60%

40%

20%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~690

0 / 11Eligibility criteria met