NCT00397332

Brief Summary

Alefacept (AMEVIVE®) is an immunosuppressive dimeric fusion protein that consists of the extracellular CD2-binding portion of the human leukocyte function antigen-3 (LFA-3) linked to the Fcof IgG1. Alefacept is produced by recombinant DNA technology in a Chinese Hamster Ovary (CHO) mammalian cell expression system. It was shown to interfere with lymphocyte activation. Alefacept was evaluated in two randomized, double-blind, placebo-controlled studies in adults with chronic plaque psoriasis. Each course consisted of once-weekly administration for 12 weeks of placebo or alefacept. The response to alefacept was significantly better in both studies. In both studies, onset of response to alefacept treatment (defined as at least 50% reduction of baseline Psoriasis Area and Severity Index (PASI)) began 60 days after the start of therapy. With one course of therapy, the median duration of response (defined as maintenance of a 75% or greater reduction in PASI) was 3.5 months for alefacept treated patients and 1 month for placebo-treated patients. Most patients who had responded to either alefacept or placebo maintained a 50% or greater reduction in PASI through the 3-month observation period. Graft versus host disease (GVHD) is the most ominous side effect of allogenic stem cell transplantation (SCT). It causes severe inflammatory process, which is usually located to the skin, gut and liver. Treatment of GVHD consists of various immuno-suppressive and immuno-modulating drugs, including steroids, cyclosporine, tacrolimus, methotrexate etc. These drugs unfortunately can also cause severe immunologic failure that makes the patient prone to infection and malignancy, and other medication-specific side effects. In spite of this effect on the immune system, not all of the patients achieve control of GVHD, which usually rapidly leads to death. Despite the use of innovative immunosuppressive modalities, the prognosis of steroid resistant GVHD is usually poor. In the following study we will evaluate the effect of alefacept on steroid unresponsive cGVHD.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2006

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

April 21, 2015

Status Verified

February 1, 2011

Enrollment Period

6.3 years

First QC Date

November 8, 2006

Last Update Submit

April 19, 2015

Conditions

Resistant Chronic GVHD

Keywords

GVHD

Outcome Measures

Primary Outcomes (2)

  • GVHD response.

    6m

  • Time to GVHD response

    6m

Secondary Outcomes (3)

  • Overall survival.

    6m

  • Disease free survival.

    6m

  • Occurrence of infections.

    6m

Interventions

AlefaceptDRUG

IM Alefacept

Eligibility Criteria

AgeUp to 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • No age limit
  • Resistant chronic GVHD

You may not qualify if:

  • Active life-threatening infection
  • Inability to comply with study requirements.
  • Known hypersensitivity to alefacept.
  • Active malignant disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Stem cell Transplantation & Cancer immunotherapy; Cell Therapy & Transplantation Biology Research Laboratory, Hadassah University Hospital

Jerusalem, 91120, Israel

Location

Related Publications (1)

  • Shapira MY, Resnick IB, Bitan M, Ackerstein A, Tsirigotis P, Gesundheit B, Zilberman I, Miron S, Leubovic A, Slavin S, Or R. Rapid response to alefacept given to patients with steroid resistant or steroid dependent acute graft-versus-host disease: a preliminary report. Bone Marrow Transplant. 2005 Dec;36(12):1097-101. doi: 10.1038/sj.bmt.1705185.

    PMID: 16247429BACKGROUND

MeSH Terms

Interventions

Alefacept

Intervention Hierarchy (Ancestors)

CD58 AntigensMembrane GlycoproteinsGlycoproteinsGlycoconjugatesCarbohydratesImmunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsMembrane ProteinsRecombinant Fusion ProteinsRecombinant Proteins

Study Officials

  • Michael Y Shapira, MD

    Department of Stem cell Transplantation & Cancer immunotherapy; Cell Therapy & Transplantation Biology Research Laboratory, Hadassah University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 9, 2006

Study Start

October 1, 2006

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

April 21, 2015

Record last verified: 2011-02

Locations

IL(1)