Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01208337
First received: September 22, 2010
Last updated: August 5, 2011
Last verified: August 2011
  Purpose

This open-label clinical trial will evaluate the safety and efficacy of Alemtuzumab (Campath, Bayer Corp., Pittsburgh) in children (0-17) and adults (18-25) receiving intestinal transplant. Seventy-five subjects receiving primary or repeat intestine transplantation will be enrolled. Primary endpoints include the incidence and severity of biopsy-proven acute cellular rejection, the incidence of freedom from steroids at 5 years, and the incidence of subjects with steroid-free Tacrolimus at whole blood concentrations < 10 ng/ml. Secondary endpoints include a) incidence and severity of opportunistic infections (CMV and EBV), post-transplant lymphoproliferative disorder (PTLD), and chronic rejection b) use of non-immunosuppressive co-medications, c) time to repopulation of all lymphocyte subsets, d) longitudinal characterization of donor-specific alloreactivity in mixed lymphocyte responses (MLR), to identify the time at which it decreases to a level less than third-party-specific alloreactivity e) longitudinal expression (mRNA) of genes, to identify rejection- and non-rejection-specific genes and f) characterization of whole genome mutations, which show differences in parent-to-child transmission between rejectors and non-rejectors. This will identify rejection- and non-rejection-specific genes bearing genetic variants, which might impact on gene function, and complement candidate gene identification efforts based on SNP transmission.


Condition Intervention Phase
Evidence of Liver Transplantation
Rejection
ALEMTUZUMAB/NATALIZUMAB [VA Drug Interaction]
Drug: Alemtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacodynamics, Pharmacogenomics, and Preliminary Safety and Efficacy of Alemtuzumab Induction and Tacrolimus in Pediatric Intestinal Transplantation (IND # 100496)

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Incidence and severity of biopsy-proven acute cellular rejection [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: April 2007
Estimated Study Completion Date: November 2014
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Alemtuzumab induction
Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.
Drug: Alemtuzumab
Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
Other Name: Campath H-1 (Genzyme, Cambridge, MA)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Months to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 0-25 years
  • male and female
  • Primary intestine transplantation, repeat intestine transplantation, and intestine transplantation in the setting of a previous or simultaneous liver transplantation

Exclusion Criteria:

  • documented non-compliance
  • known hypersensitivity to egg protein
  • pregnancy
  • malignancy
  • hepatitis C and B defined as anti-HCV antibody positive, and anti-Hepatitis B surface antigen or Hepatitis B core antibody positive or HBV DNA positive.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01208337

Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Rakesh Sindhi, MD Children's Hospital of Pittsburgh of UPMC/University of Pittsburgh
  More Information

No publications provided

Responsible Party: Rakesh Sindhi, MD, Children's Hospital of Pittsburgh of UPMC
ClinicalTrials.gov Identifier: NCT01208337     History of Changes
Other Study ID Numbers: IRB0701088
Study First Received: September 22, 2010
Last Updated: August 5, 2011
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Rejection

Additional relevant MeSH terms:
Alemtuzumab
Campath 1G
Antibodies, Neoplasm
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 17, 2014