Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Prometheus Laboratories
Information provided by (Responsible Party):
John Koreth, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01366092
First received: June 2, 2011
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

Chronic GVHD is a medical condition that may occur after a bone marrow, stem cell or cord blood transplant. The donor's immune system may recognize the your body (the host) as foreign and attempt to 'reject' it. This process is known as graft-versus-host-disease. It is thought that IL-2 may help control chronic GVHD by stopping the donor's immune system from 'rejecting' your body. In this research study, we are looking to see how IL-2 can be used in combination with steroids to treat cGVHD.


Condition Intervention Phase
Chronic Graft-versus-host Disease
Drug: Interleukin-2
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Daily Low-Dose Interleukin-2 (IL-2) for Steroid-Refractory Chronic Graft-Versus-Host-Disease

Resource links provided by NLM:


Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:
  • To determine the overall response rate of low-dose daily SC IL-2 in steroid-refractory cGVHD [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine toxicity of low-dose SC IL-2 therapy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
  • To determine ongoing prednisone use with IL-2 therapy [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess overall survival, progression-free survival, non-relapse mortality and relapse at 1 year after start of IL-2 [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To assess the immunologic effects of low-dose daily SC IL-2 [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 41
Study Start Date: July 2011
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Interleukin-2 Drug: Interleukin-2
Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
Other Name: IL-2

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01366092

Locations
United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02214
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Sponsors and Collaborators
Dana-Farber Cancer Institute
Prometheus Laboratories
Investigators
Principal Investigator: John Koreth, MBBS, DPhil Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: John Koreth, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01366092     History of Changes
Other Study ID Numbers: 11-149, P01CA142106
Study First Received: June 2, 2011
Last Updated: June 27, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Dana-Farber Cancer Institute:
stem cell transplant
GVHD
bone marrow transplant
cord blood transplant
regulatory T cell
interleukin

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Interleukin-2
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 24, 2014