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
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: 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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014