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Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Rajinder Bajwa, Nationwide Children's Hospital
ClinicalTrials.gov Identifier:
NCT01485055
First received: December 1, 2011
Last updated: April 25, 2016
Last verified: April 2016
  Purpose

Acute Graft Versus Host Disease (GVHD) is a serious medical condition that is a common development after Bone Marrow Transplant (BMT). Acute GVHD happens when the donor cells attack and damage your tissues and organs after transplant.

Acute GVHD often causes: Skin rashes, nausea, vomiting, abdominal pain, diarrhea (may have blood), liver damage that can cause inflammation in the liver or jaundice (yellowing of the skin or eyes), damage to other organs

Steroids are the first line of treatment for acute GVHD. About a quarter of the patients that develop acute GVHD may not respond to steroid and have steroid refractory GVHD (SR-aGVHD). Patients with SR-aGVHD may need other medications. SR-aGVHD, is a potentially life threatening condition. There is no standard treatment and it may not respond to treatment.

The goals of this study are to find out if Infliximab and basiliximab can treat SR-aGVHD.

Participants in this study will receive combination therapy (2 drugs: infliximab and basiliximab) once a week for four weeks.


Condition Intervention Phase
Graft Versus Host Disease
Steroid Refractory GVHD
Acute GVH Disease
Drug: Infliximab and Basiliximab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Infliximab and Basiliximab for Treatment of Steroid Refractory Acute Graft Versus Host Disease

Resource links provided by NLM:


Further study details as provided by Nationwide Children's Hospital:

Primary Outcome Measures:
  • Treatment [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    To estimate the complete response rate by 28 days after starting study drugs, without additional therapy for patients with steroid refractory aGvHD.


Enrollment: 10
Study Start Date: December 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Infliximab and Basiliximab

Other Names:

Simulect Remicade Monoclonal antibody

Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.

Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times.

Drug: Infliximab and Basiliximab

Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.

Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times.

Other Names:
  • Simulect
  • Remicade
  • Monoclonal antibody

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Months to 75 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Any patient with either progressive aGvHD or Steroid Refractory aGvHD after Bone marrow transplant
  • Prophylactic GvHD therapy with cyclosporine, tacrolimus, MMF, or sirolimus can be continued.
  • Patients with late onset acute GvHD will be eligible
  • Patients should have an absolute neutrophil count (ANC) of >500µL
  • Patients with renal dysfunction or veno-occlusive disease are eligible

Exclusion Criteria:

  • Patient should not be getting any other experimental therapy for aGvHD
  • Patients with active uncontrolled life threatening infection (s) from viral, bacterial, fungal or other organisms will be excluded. Patients with HIV infection will be excluded
  • Patients who are pregnant, breast feeding, or if sexually active and unwilling to use effective birth control for the duration of this study will be excluded
  • Patients with NYHA Class III or IV heart failure will be excluded
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485055

Locations
United States, Florida
University of Florida College of Medicine
Gainesville, Florida, United States, 32610
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Texas
Methodist Healthcare System of San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Nationwide Children's Hospital
Investigators
Principal Investigator: Rajinder S Bajwa, MD Nationwide Children's Hospital
  More Information

Publications:
Responsible Party: Rajinder Bajwa, Rajinder.P.S. Bajwa, MBBS, MD, MRCP Assitant Professor of Pediatrics at Ohio State University Department of Hematology/Oncology/BMT, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT01485055     History of Changes
Other Study ID Numbers: NCH-IRB11-00659 
Study First Received: December 1, 2011
Last Updated: April 25, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Nationwide Children's Hospital:
aGVHD
GVHD
Graft versus host disease
Acute graft versus host disease
Steroid refractory graft versus host disease
Bone marrow transplant
BMT
HSCT
infliximab
basiliximab
Monoclonal antibody treatment

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases
Antibodies
Immunoglobulins
Antibodies, Monoclonal
Basiliximab
Infliximab
Immunologic Factors
Physiological Effects of Drugs
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 30, 2016