NCT00201799

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2004

Typical duration for phase_2

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

February 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

2.5 years

First QC Date

September 12, 2005

Last Update Submit

June 9, 2015

Conditions

Graft-Versus-Host Disease

Keywords

Hematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (1)

  • 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.

    * For matched related donor transplants, we will test the null hypothesis H0: p ≥0.40 versus the alternative H1: p≤0.20, where p is the probability of grade II-IV acute GvHD by day +100. * For matched unrelated donor transplants, we will test the null hypothesis H0: p≥0.70 versus the alternative H1: p≤0.50, where p is the probability of grade II-IV acute GvHD by day +100.

    2004-2008

Secondary Outcomes (1)

  • 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).

    2004-2008

Study Arms (1)

Infliximab

EXPERIMENTAL

Patients will be treated with infliximab day 1 prior to starting myeloblative chemotherapy or radiotherapy. A total of 6 doses will be administered.

Drug: Infliximab

Interventions

InfliximabDRUG

A total of 6 doses of Infliximab will be administered as follows: Dose 1: 10 mg/kg IV one day prior to commencing the myeloablative preparative regimen Dose 2: 10 mg/kg IV on day 0 to be given after peripheral blood stem cell infusion Dose 3: 10 mg/kg IV on day +7 Dose 4: 10 mg/kg IV on day +14 Dose 5: 10 mg/kg IV on day +28 Dose 6: 10 mg/kg IV on day +42

Also known as: (Remicade®, Centocor)
Infliximab

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • 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.

    PMID: 18541197RESULT

Related Links

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Craig Hofmeister, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

February 1, 2004

Primary Completion

August 1, 2006

Study Completion

March 1, 2008

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

US(1)