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
18 Years
N/A
Both
Chronic Graft-versus-host Disease
Trial Information
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
- 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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Efficacy
Outcome Description:
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.
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Corey Cutler, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dana-Farber Cancer Institute
Authority:
United States: Institutional Review Board
Study ID:
10-230
NCT ID:
NCT01226420
Start Date:
October 2010
Completion Date:
January 2013
Related Keywords:
- Chronic Graft-versus-host Disease
- GVHD
- Alefacept
- Amevive
- Graft vs Host Disease
Name | Location |
|---|---|
| Dana-Farber Cancer Institute | Boston, Massachusetts 02115 |
| Fred Hutch Cancer Research Center | Seattle, Washington 98103-1204 |
