Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Dana-Farber Cancer Institute
Collaborators:
Brigham and Women's Hospital
Astellas Pharma Inc
Information provided by (Responsible Party):
Corey S. Cutler, MD, MPH, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT01226420
First received: October 21, 2010
Last updated: January 24, 2012
Last verified: January 2012
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Purpose
Alefacept is a drug tht may reduce the number of T cells in circulation. This drug has been used in the treatment of psoriasis, which is a skin disorder also caused by T cells, like chronic GVHD. Information from studies in psoriasis and in other patients with GVHD suggests that this drug may help to treat chronic GVHD. Chronic GVHD is a medical condition that can develop after allogeneic stem cell transplantation. It occurs when the donor immune cells (the "graft") attack and damage organs and tissue (the "host"). It is thought that T cells, a subtype of immune cells, are responsible for the tissue damage in chronic GVHD. In this research study we are looking to see how well Alefacept works in treating chronic GVHD that has not resolved after therapy with corticosteroids.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Graft-versus-host Disease |
Drug: Alefacept |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II, Open-Label, Multi-Center Study to Assess the Safety and Efficacy of Alefacept in Subjects With 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:
- Efficacy [ Time Frame: 2 years ] [ Designated as safety issue: No ]Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compated to baseline in subects with steroid refractory cGVHD.
Secondary Outcome Measures:
- Safety [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]Assess the safety of alefacept in this patient population
| Estimated Enrollment: | 50 |
| Study Start Date: | October 2010 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | September 2012 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Alefacept
Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12
Other Name: Amevive
- During the first week of treatment, participants will receive 2 doses of Alefacept intravenously (Day 1 and Day 4). During weeks 2-12, Alefacept will be given subcutaneously once weekly.
- On weeks 1, 2 and every other week through Week 12 of study treatment, participants will have a physical exam, blood tests, and be asked general health and specific questions about any problems they may be having.
- Every other week, participants will be asked to complete a questionnaire about their physical symptoms, activity level and emotional well being.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 18 years of age or older
- Diagnosed with cGVHD according to NIH criteria
- Active cGVHD despite treatment with corticosteroids AND one additional immunosuppressive agent for at least 4 weeks, within 52 weeks of enrollment.
- Subject is a recipient of related or unrelated BMT or PBSCT
- Subject underwent transplantation at least 6 months prior to enrollment
- Subject is on stable immunosuppressive regimen for 2 weeks prior to enrollment. Adjustment of immunosuppressive medications to maintain a therapeutic level is permitted.
- Female of child bearing potential must have a negative pregnancy test prior to first dose of alefacept and must agree to practice effective contraception during the study. Men must also agree to use adequate contraception prior to study entry and for the duration of the study.
- Meets medication restriction requirements and agrees to follow medications restrictions during study.
Exclusion Criteria:
- Received donor lymphocyte infusions in the preceding 100 days
- Currently undergoing ECP
- Subject is recipient of related or unrelated UCB
- Subject has bronchiolitis obliterans, bronchiolitis obliterans with organizing pneumonia or cryptogenic organizing pneumonia as the sole manifestation of cGVHD
- Uncontrolled intercurrent active infection.
- Absolute neutrophil count < 1000/L
- AST, ALT or total bilirubin > 2x institutional upper limit of normal unless this is a manifestation of GVHD
- Recurrent or progressive malignancy at any time after HCT, as applicable for the individual malignancy
- Subject was in any clinical study within the last 30 days
- Receipt of 5 or more prior agents to treat cGVHD
- Known hypersensitivity to alefacept or any components of the study medication
- Known to be positive for human immunodeficiency virus (HIV) antibodies
- Currently enrolled in any other study for chronic GVHD treatment and receiving treatment under the study or previous participation in this study.
- Pregnant or nursing
- Concurrent illness which, in the opinion of the Investigator, may interfere with treatment or evaluation of safety
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01226420
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Washington | |
| Fred Hutch Cancer Research Center | |
| Seattle, Washington, United States, 98109-1024 | |
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Astellas Pharma Inc
Investigators
| Principal Investigator: | Corey Cutler, MD | Dana-Farber Cancer Institute |
More Information
No publications provided
| Responsible Party: | Corey S. Cutler, MD, MPH, Principal Investigator, Dana-Farber Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT01226420 History of Changes |
| Other Study ID Numbers: | 10-230 |
| Study First Received: | October 21, 2010 |
| Last Updated: | January 24, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dana-Farber Cancer Institute:
|
GVHD Alefacept Amevive |
Additional relevant MeSH terms:
|
Graft vs Host Disease Immune System Diseases Alefacept |
Dermatologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 21, 2013