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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

Must not have

Concurrent use of calcineurin-inhibitors plus sirolimus

Ongoing prednisone requirement >1 mg/kg/day

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the start of treatment to 1 year

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I received a stem cell transplant that was a close match to my tissue type.

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My chronic GVHD hasn't improved despite taking steroids for 4 weeks.

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I can take care of myself and am up and about more than half of the day.

Exclusion Criteria

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

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I am currently taking calcineurin inhibitors and sirolimus.

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I need more than 1 mg/kg/day of prednisone.

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I have a history of blood clotting disorders.

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I do not have allergies or reactions to heparin or 8-MOP.

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I haven't taken new immune-suppressing drugs in the last 100 days.

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I currently have an infection that isn't under control.

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

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I have active hepatitis B or C.

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My cancer has returned after treatment.

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I am HIV-positive and on combination antiretroviral therapy.

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I have received an organ transplant from another person.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the start of treatment to 1 year for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of Participant With Response at Week 16

Secondary study objectives

Non-relapse Mortality

Number of Grade 3 or Higher Toxicities Related to ECP Plus Low-dose SC IL-2 Therapy

Overall Survival

+4 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: 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

~690

0 / 14Eligibility criteria met