Safety and Efficacy of Alemtuzumab in Pediatric Intestinal Transplantation

NCT01208337 | Completed Phase 2 Results DMC

• 1 other identifier: IRB0701088
• Study Type: interventional
• Target: 23
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Evidence of Liver Transplantation; Rejection; ALEMTUZUMAB

Keywords

Rejection

Outcome Measures

Primary Outcomes (1)

• Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)

  Asses safety of Alemtuzumab in combination with Tacrolimus and steroids in twenty-three pediatric intestine allograft recipients by calculating the rate in which PTLD occurred amongst the study population.

  5 Year

Secondary Outcomes (4)

• Incidence of Biopsy-proven Acute Cellular Rejection

  1 Year

• Incidence of Patients in Whom Steroids Are Not Used

  1 year

• Incidence of Patients in Whom Tacrolimus Whole Blood Concentration Less Than 10 ng/ml Are Being Used at 1-year Follow-up.

  1 year

• Incidence of Patients in Whom Steroids Are Not Used

  5 year

Study Arms (1)

Alemtuzumab induction

OTHER

Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.

Drug: Alemtuzumab

Interventions

Alemtuzumab DRUG

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

Also known as: Campath H-1 (Genzyme, Cambridge, MA)

Alemtuzumab induction

Eligibility Criteria

• Age: 4 Months - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Alemtuzumab

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Rakesh Sindhi
• Organization: University of Pittsburgh

rakesh.sindhi@chp.edu

412-692-6110

Study Officials

• Rakesh Sindhi, MD

  Children's Hospital of Pittsburgh of UPMC/University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery

Study Record Dates

• First Submitted: September 22, 2010
• First Posted: September 23, 2010
• Study Start: April 1, 2007
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 8, 2023
• Results First Posted: June 20, 2016

Record last verified: 2023-03