Daily IL-2 for Steroid-Refractory Chronic Graft-versus-Host-Disease
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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 |
- 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 ]
- 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: | 31 |
| 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 |
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| Contact: John Koreth, MBBS, DPhil | 617-632-2949 | jkoreth@partners.org |
| Contact: Bhavjot Bindra | 617-632-6577 | bbindra@partners.org |
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02214 | |
| Principal Investigator: John Koreth, MBBS, DPhil | |
| Beth Israel Deaconess Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Principal Investigator: David Avigan, MD | |
| Massachusetts General Hospital | Not yet recruiting |
| Boston, Massachusetts, United States, 02214 | |
| Principal Investigator: Yi-Bin Chen, MD | |
| 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: | January 28, 2013 |
| 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 June 17, 2013