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A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease

Phase 1
18 Years
Not Enrolling
Graft Versus Host Disease

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Trial Information

A Phase I Study of Ultra-Low Dose Subcutaneous Interleukin-2 (IL-2) for Treatment of Refractory Chronic Graft Versus Host Disease

- IL-2 will be given daily through an injection under the skin for a period of 8 weeks.
To determine the highest safest dose of IL-2, the dose participants receive will
increase as lower doses are determined to be safe. There will be three dose levels.

- Participants will be seen periodically while they are receiving IL-2. Physical exams
and blood tests will be performed weekly for the first two weeks and then every other
week until week 8.

Inclusion Criteria:

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

- Patients must be at least 180 days from the allogeneic stem cell transplantation

- Steroid refractory cGVHD, defined as having persistent symptoms and signs of GVHD
despite the use of prednisone for at least 4 weeks in the preceding 12 months without
complete resolution of signs and symptoms.

- Stable dose of corticosteroids for 4 weeks prior to enrollment

- No addition or subtraction of other immunosuppressive medications for 4 weeks prior
to enrollment.

- Adequate bone marrow, renal and hepatic function as outlined in the protocol

- 18 years of age or older

- ECOG Performance Status of 0-2

Exclusion Criteria:

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

- Exposure to any new immunosuppressive medication in the 4 weeks prior to enrollment

- Concurrent ECP therapy within 4 weeks prior to enrollment

- Post-transplant exposure to any novel immunosuppressive medication within 100 days
prior to enrollment

- Donor lymphocyte infusion within 100 days prior to IL-2 therapy

- Active malignant disease relapse

- Active, uncontrolled infection

- Positive serologic test for Hepatitis B or a positive serologic or nucleic acid test
for Hepatitis C

- HIV seropositivity

- Life expectancy < 3 months

- Pregnancy or lactation

- Inability to comply with IL-2 treatment regimen

- Uncontrolled cardiac angina or symptomatic congestive heart failure

- Organ transplant (allograft) recipient

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated dose level and toxicity profile of an 8 week course of IL-2 in patients with cGVHD and an inadequate response to steroids.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

John Koreth, MBBS, D.Phil

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

August 2007

Completion Date:

June 2011

Related Keywords:

  • Graft Versus Host Disease
  • Chronic GVHD
  • Steroid refractory GVHD
  • allogeneic stem cell transplantation
  • Graft vs Host Disease



Dana-Farber Cancer Institute Boston, Massachusetts  02115