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A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-Versus-Host-Disease


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Chronic Graft-versus-host Disease

Thank you

Trial Information

A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-Versus-Host-Disease


You will give yourself or be given IL-2 daily through an injection under your skin. You
should rotate the injection site, if possible. You will do this once every day for 12 weeks.
You will then have 4 weeks off of IL-2. During the first 6 weeks of IL-2, you will continue
to take steroids without changing the dose your doctor has set for you while you are on
IL-2. After 6 weeks of IL-2 therapy, your doctor may reduce the amount of steroids you take.

While you are on study, a member of the study team will examine you to evaluate your cGVHD.
These assessments may include examination of your skin, joints/muscles, eyes, mouth, lungs
and gastrointestinal system.

You will have clinic visits for evaluation of toxicity and clinical benefit approximately
every 4 weeks. You will also have immunologic assays approximately every 8 weeks.
Immunologic assays will measure the effect of IL-2 on immune cells.

You will be on the study for about 16 weeks. You may continue on study treatment for longer
if you experience a clinical benefit.


Inclusion Criteria:



- Recipient of allogeneic stem cell transplantation with myeloablative or
non-myeloablative conditioning regimens

- Steroid refractory cGVHD with systemic therapy onset within the prior 6 months

- No more than 2 prior lines of cGVHD therapy

- Estimated life expectancy > 3 months

- Adequate organ function

Exclusion Criteria:

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

- Concurrent use of calcineurin-inhibitors plus sirolimus

- History of thrombotic microangiopathy, hemolytic-uremic syndrome or thrombotic
thrombocytopenic purpura

- Active malignant relapse

- Active uncontrolled infection

- Uncontrolled cardiac angina or symptomatic congestive heart failure

- Organ transplant (allograft) recipient

- HIV-positive on combination antiretroviral therapy

- Active hepatitis B or C

- Pregnant or breast-feeding

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the overall response rate of low-dose daily SC IL-2 in steroid-refractory cGVHD

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

John Koreth, MBBS, DPhil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

11-149

NCT ID:

NCT01366092

Start Date:

July 2011

Completion Date:

Related Keywords:

  • Chronic Graft-versus-host Disease
  • stem cell transplant
  • GVHD
  • bone marrow transplant
  • cord blood transplant
  • regulatory T cell
  • interleukin
  • Graft vs Host Disease

Name

Location
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617