Target Cell Therapy for Lymphoma

Overview

Status: Not yet recruiting
Keywords: retrospective , pathology review , EBV , Hodgkin lymphoma
IRB Number: 00063386
Specialty: Pathology
Sub Specialties: Hematopathology

Brief Summary

The purpose of this study is to perform central pathology review and EBV testing on patient samples in order to verify eligibility for the LCTC clinical trial, and to perform central pathology review to verify eligibility for the REBOOT clinical trial. 

The LCTC clinical trial will assess the safety and toxicity associated with administering allogeneic human leukocyte antigen (HLA) matched donor derived latent membrane protein (LMP) specific-cytotoxic T cell lymphocytes (CTLs) in children, adolescents and young adults (CAYA) with Epstein barr virus (EBV)-associated refractory/relapsed Hodgkin Lymphoma (HL) following reduced intensity conditioning (RIC) and allogeneic hematopoietic stem cell transplantation (HSCT).  This trial will be run by the Childhood, Adolescent and Young Adult (CAYA) Lymphoma Cell Therapy Consortium (LCTC).   Enrollment of patients at the University of Utah will be covered under a separate IRB protocol (0062028, P.I. Michael Pulsipher MD).

The objective of the REBOOT trial to determine the safety and efficacy of reduced intensity chemotherapy with the addition of rituximab in children and adolescents with B-NHL.  Enrollment of patients at the University of Utah will be covered under a separate IRB protocol (0063155, P.I. Phillip Barnette, MD). 

This protocol only involves review of diagnostic biopsy tissues collected at participating institutions as a part of patient care.  Additional studies may be performed on the tissues as needed to confirm the diagnosis, but no additional patient procedures are involved. 

Objectives:

1.  Determine eligibility for the LCTC CTL therapy clinical trial by performing central pathology review of diagnostic specimens to confirm the diagnosis of Hodgkin lymphoma.

2.  Determine eligibility for the LCTC CTL therapy clinical trial by performing EBV studies on diagnostic pathology materials submitted for central pathology review.

3.  Determine eligibility for the REBOOT clinical trial be performing central pathology review and confirming CD20 expression.

Principal Investigator: Sherrie Perkins
Department: Pathology
Co Investigator: Rodney Miles
Co Investigator: Michael Pulsipher

Contact Information

Name:Michael Pulsipher
Phone: 801-588-2680
Email: michael.pulsipher@hsc.utah.edu

Inclusion Criteria

Confirmation of the diagnosis by central pathology review is required for continued inclusion in the LCTC clinical trial.  Confirmation of the diagnosis is required for inclusion in the REBOOT clinical trial.

Because this study only involves central pathology review and EBV testing of diagnostic materials, criteria for inclusion are only that the patient has otherwise met criterial for participation in the LCTC ore REBOOT clinical trial.

Exclusion Criteria

Patients that do not meet criteria for inclusion in the clinical trial will be excluded from central pathology review. 

Criteria for case exclusion based on central pathology review include:

1.  Morphologically or immunophenotypically unclassifiable lymphoma.

2.  Pathology central review diagnosis not eligible for this study.

3.  Inability to demonstrate tumor EBV positivity by EBER in situ hybridization or LMP1 immunohistochemistry for LCTC.

4.  Lack of CD20 expression for the REBOOT trial.