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Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease

Primary Purpose

Chronic Graft-versus-host Disease

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Alefacept
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Graft-versus-host Disease focused on measuring GVHD, Alefacept, Amevive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dana-Farber Cancer Institute
  • Fred Hutch Cancer Research Center
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alefacept

Arm Description

Alefacept iv

Outcomes

Primary Outcome Measures

Efficacy
Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.

Secondary Outcome Measures

Safety of Alefacept Infusions in Patients With Chronic GVHD.
Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.

Full Information

First Posted
October 21, 2010
Last Updated
August 11, 2013
Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01226420
Brief Title
Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Terminated
Why Stopped
Discontinuation of drug supply from Astellas.
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Brigham and Women's Hospital, Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft-versus-host Disease
Keywords
GVHD, Alefacept, Amevive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alefacept
Arm Type
Experimental
Arm Description
Alefacept iv
Intervention Type
Drug
Intervention Name(s)
Alefacept
Other Intervention Name(s)
Amevive
Intervention Description
Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12
Primary Outcome Measure Information:
Title
Efficacy
Description
Proportion of patients with a favorable response, defined as a complete or partial remission at week 12 as compared to baseline in subjects with steroid refractory cGVHD.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Safety of Alefacept Infusions in Patients With Chronic GVHD.
Description
Assess the safety of alefacept in this patient population. The number of adverse events (including hematological and non-hematological safety events) will be used for safety assessment.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey Cutler, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Fred Hutch Cancer Research Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109-1024
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Alefacept in Subjects With Steroid-Refractory Chronic Graft-versus-Host Disease

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