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

NCT01226420 | Terminated Phase 2 Results DMC

• 1 other identifier: 10-230
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Graft-versus-host Disease

Keywords

GVHD; Alefacept; Amevive

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• Safety of Alefacept Infusions in Patients With Chronic GVHD.

  2 years

Study Arms (1)

Alefacept

EXPERIMENTAL

Alefacept iv

Drug: Alefacept

Interventions

Alefacept DRUG

Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12

Also known as: Amevive

Alefacept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Brigham and Women's Hospital: collaborator
• Astellas Pharma Inc: collaborator

Study Sites (3)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

Fred Hutch Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Alefacept

Condition Hierarchy (Ancestors)

Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Graft vs Host Disease; Immune System Diseases

Intervention Hierarchy (Ancestors)

CD58 Antigens; Membrane Glycoproteins; Glycoproteins; Glycoconjugates; Carbohydrates; Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Membrane Proteins; Recombinant Fusion Proteins; Recombinant Proteins

Results Point of Contact

• Title: Corey S. Cutler, MD, MPH, FRCP(C)
• Organization: Dana-Farber Cancer Institute

cscutler@partners.org

617-632-5946

Study Officials

• Corey Cutler, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 21, 2010
• First Posted: October 22, 2010
• Study Start: October 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: August 13, 2013
• Results First Posted: August 13, 2013

Record last verified: 2013-08

Locations

US (3)