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Sponsored by: |
Hadassah Medical Organization |
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Information provided by: | Hadassah Medical Organization |
ClinicalTrials.gov Identifier: | NCT00397332 |
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.
Condition | Intervention | Phase |
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Resistant Chronic GVHD |
Drug: Alefacept |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | An Investigator Initiated Open-label and Explorative Study of Alefacept Treatment for Chronic Extensive Graft Versus Host Disease |
Estimated Enrollment: | 20 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Michael Y Shapira, MD | 972-2-6778351 | shapiram@hadassah.org.il |
Israel | |
Department of Stem cell Transplantation & Cancer immunotherapy; Cell Therapy & Transplantation Biology Research Laboratory, Hadassah University Hospital | Recruiting |
Jerusalem, Israel, 91120 | |
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il | |
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il | |
Principal Investigator: Michael Y Shapira, MD |
Principal Investigator: | Michael Y Shapira, MD | Department of Stem cell Transplantation & Cancer immunotherapy; Cell Therapy & Transplantation Biology Research Laboratory, Hadassah University Hospital |
Responsible Party: | Hadassah University Hospital ( Michael Shapira, MD ) |
Study ID Numbers: | MYS-05-HMO-CTIL |
Study First Received: | November 8, 2006 |
Last Updated: | August 16, 2009 |
ClinicalTrials.gov Identifier: | NCT00397332 History of Changes |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
GVHD |
Graft Versus Host Disease Alefacept Graft vs Host Disease Homologous Wasting Disease |
Alefacept Immune System Diseases Therapeutic Uses |
Graft vs Host Disease Dermatologic Agents Pharmacologic Actions |