Clinical trial NCT00201799: Infliximab for the Prevention of Graft-versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation
Official title: Phase II Trial of Infliximab for the Prevention of Acute Graft-versus-Host Disease Following Allogenic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Graft-Versus-Host Disease
Keywords: Hematopoietic Stem Cell Transplantation
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: 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.

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 criteria: Inclusion Criteria:

* Patients undergoing allogeneic HCT for the following disorders:

  * Acute myelogenous leukemia
  * Acute lymphoblastic leukemia
  * Non-Hodgkin's lymphoma
  * Hodgkin's disease
  * Multiple myeloma
  * Chronic lymphocytic leukemia
  * Chronic myeloid leukemia in accelerated or blast crisis at time of transplant.
* Age \>20 yrs

Exclusion Criteria:

* Patients undergoing allogeneic stem cell transplantation for chronic myelogenous leukemia and aplastic anemia are excluded.
* Pregnant or breast-feeding females.

Primary outcomes:
measure: Evaluate efficacy of infliximab in reducing incidence of grade II-IV acute GvHD by day +100 post transplant in patients undergoing allogenic HCT and receiving standard cyclosporine and short course methotrexate GvHD prophylaxis.
timeFrame: 2004-2008
Secondary outcomes:
measure: Assess the effect of infliximab on treatment-related mortality at 100 days post-transplant and on the incidence and severity of regimen related toxicity, including veno-occlusive disease (VOD) of the liver and interstitial pneumonitis (IP).
timeFrame: 2004-2008
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Craig Hofmeister, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hamadani M, Hofmeister CC, Jansak B, Phillips G, Elder P, Blum W, Penza S, Lin TS, Klisovic R, Marcucci G, Farag SS, Devine SM. Addition of infliximab to standard acute graft-versus-host disease prophylaxis following allogeneic peripheral blood cell transplantation. Biol Blood Marrow Transplant. 2008 Jul;14(7):783-9. doi: 10.1016/j.bbmt.2008.04.006.