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Infliximab for the Prevention of Graft-Versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation
This study is ongoing, but not recruiting participants.
Sponsored by: Ohio State University Comprehensive Cancer Center
Information provided by: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201799
  Purpose

This study will evaluate the efficacy of infliximab in reducing the incidence of grade II-IV acute graft versus host disease by day +100 post-transplant in patients undergoing allogeneic hematopoietic stem cell transplant.


Condition Intervention Phase
Graft-Versus-Host Disease
Drug: Infliximab
Phase II

Drug Information available for: Infliximab
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title: Phase II Trial of Infliximab for the Prevention of Acute Graft-Versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation

Further study details as provided by Ohio State University Comprehensive Cancer Center:

Estimated Enrollment: 84
Study Start Date: February 2004
Estimated Study Completion Date: December 2005
Detailed Description:

Rationale: Acute graft host disease (GvHD) remains a barrier to successful hematopoietic stem cell transplantation (HCT) used for the treatment of cancers in some patients. GvHD can result from a lack of compatibility between the donor and recipient. Research suggests another primary cause of GvHD comes from cytokines, or a substance produced by cells of the immune system that affect the immune response in both positive and negative ways. Infliximab is an antibody that directly targets the cytokine associated with GvHD. This study is building upon previous research to assess infliximab’s ability to prevent GvHD after HCT.

Purpose: This study is evaluating the efficacy of infliximab in reducing the incidence of GvHD after HCT. The safety of this approach, along with changes to specific cytokines from this treatment, will also be measured.

Treatment: Patients in this study will receive infliximab through intravenous infusion. Infliximab will be administered in six doses, including one day before chemotherapy or radiotherapy, after the stem cell infusion, and then on days 7, 14, 28 and 42. Standard post-transplant treatments of cyclosporine (Neoral) and methotrexate (Methotrexate) will also be given through intravenous infusion. Cyclosporine will be given on day 1, and the subsequent schedule will be determined on an individual basis. Methotrexate will be administered on days 1, 3, 6, and 11. Several tests and exams will be given throughout the study to closely monitor patients.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing allogeneic Hematopoietic Stem Cell Transplantation with AML, ALL, NHL, HL, MM, CLL, or CML in blast crisis
  • age >20 yrs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00201799

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
Investigators
Principal Investigator: Sherif Farag Ohio State University
  More Information

Study ID Numbers: OSU-0323
Study First Received: September 12, 2005
Last Updated: December 26, 2006
ClinicalTrials.gov Identifier: NCT00201799  
Health Authority: United States: Food and Drug Administration

Keywords provided by Ohio State University Comprehensive Cancer Center:
Hematopoietic Stem Cell Transplantation

Study placed in the following topic categories:
Infliximab
Graft versus host disease
Graft vs Host Disease
Homologous wasting disease

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immune System Diseases
Therapeutic Uses
Gastrointestinal Agents
Antirheumatic Agents
Dermatologic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009