RECRUITING

A Study to Evaluate Tabelecleucel in Participants With Epstein-barr Virus (EBV)-Associated Diseases

Conditions

Epstein-Barr Virus (EBV)-Associated Diseases EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD)EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD)Solid Organ Transplant Complications Lymphoproliferative Disorders Allogeneic Hematopoietic Cell Transplant Stem Cell Transplant Complications EBV+ Sarcomas Leiomyosarcoma Allogeneic, Off-The-Shelf T-cell Immunotherapy Epstein-Barr Virus (EBV)Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL)Solid Organ Transplant (SOT)Hematopoietic Cell Transplant (HCT)EBVision

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.

Official Title

An Open-label, Single-arm, Multicohort, Phase 2 Study to Assess the Efficacy and Safety of Tabelecleucel in Subjects With Epstein-Barr Virus-associated Diseases (EBVision)

Quick Facts

Study Start:2021-07-14

Study Completion:2028-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04554914

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Diagnosis of EBV+ disorder. * Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants from ≥ 1 year to \< 16 years. * Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.	* Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy. * Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment, or known history of human immunodeficiency virus (HIV) infection. * Suspected or confirmed Grade ≥ 2 acute graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system or extensive chronic GvHD per National Institutes of Health (NIH) consensus criteria at the time of the enrollment. * Need for vasopressor or ventilatory support at the time of enrollment. * Prior therapy (in order of increasing washout period) prior to enrollment as follows: * Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational product and/ or any chemotherapy (systemic or intrathecal), targeted small molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody use is permitted within the washout period if a subsequent disease response assessment indicates disease progression. * Within 8 weeks: prior tabelecleucel (\> 8 weeks prior to enrollment) is permitted if response was obtained or if usual protocol-directed therapeutic options were not exhausted, for cellular therapies (chimeric antigen receptor therapies directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or virus-specific T-cells); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab). * Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above * Women who are breastfeeding or pregnant. * Unwilling to comply with protocol specified contraceptive/reproductive restrictions from enrollment through 90 days after the last treatment. * Ongoing need for daily steroids of \> 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis (for participants with CNS disease, protocol-specified dexamethasone is permitted and concludes by the time of enrollment). * Any conditions that may put the study outcomes at undue risk (life expectancy \< 60 days or any life-threatening illness, medical condition, or organ system dysfunction). * For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid organ transplant. * For participants with EBV+ 1L PTLD: prior systemic therapy for PTLD.

Inclusion Criteria

Exclusion Criteria

* Diagnosis of EBV+ disorder.
* Eastern Cooperative Oncology Group performance status ≤ 3 for participants aged ≥ 16 years; Lansky score ≥ 20 for participants from ≥ 1 year to \< 16 years.
* Adequate organ function test results, unless organ dysfunction is considered to be due to the underlying EBV-associated disease by the investigator.

* Currently active Burkitt, T-cell, natural killer/T-cell lymphoma/LPD, Hodgkin, plasmablastic, transformed lymphoma, active hemophagocytic lymphohistiocytosis, or other malignancies requiring systemic therapy.
* Serious known active infections, defined as ongoing uncontrolled adenovirus infection or infections requiring systemic therapy at the time of enrollment, or known history of human immunodeficiency virus (HIV) infection.
* Suspected or confirmed Grade ≥ 2 acute graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system or extensive chronic GvHD per National Institutes of Health (NIH) consensus criteria at the time of the enrollment.
* Need for vasopressor or ventilatory support at the time of enrollment.
* Prior therapy (in order of increasing washout period) prior to enrollment as follows:
* Within 4 weeks or 5 half-lives (whichever is shorter) for any investigational product and/ or any chemotherapy (systemic or intrathecal), targeted small molecule therapy, or antibody/biologic therapy. Note: prior anti-CD20 antibody use is permitted within the washout period if a subsequent disease response assessment indicates disease progression.
* Within 8 weeks: prior tabelecleucel (\> 8 weeks prior to enrollment) is permitted if response was obtained or if usual protocol-directed therapeutic options were not exhausted, for cellular therapies (chimeric antigen receptor therapies directed at T-cells or T-cell subsets, donor lymphocyte infusion, other CTLs or virus-specific T-cells); and/or therapies which could impact tabelecleucel function (anti-thymocyte globulin, alemtuzumab).
* Any prior treatment with EBV-CTLs with the exception of tabelecleucel as above
* Women who are breastfeeding or pregnant.
* Unwilling to comply with protocol specified contraceptive/reproductive restrictions from enrollment through 90 days after the last treatment.
* Ongoing need for daily steroids of \> 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis (for participants with CNS disease, protocol-specified dexamethasone is permitted and concludes by the time of enrollment).
* Any conditions that may put the study outcomes at undue risk (life expectancy \< 60 days or any life-threatening illness, medical condition, or organ system dysfunction).
* For participants with PID LPD or AID LPD: history of prior allogeneic HCT or solid organ transplant.
* For participants with EBV+ 1L PTLD: prior systemic therapy for PTLD.

Contacts and Locations

Study Contact

Cindy Jachym

CONTACT

6 22 38 92 79

cindy.jachym@pierre-fabre.com

Principal Investigator

Anke Friedetzky

STUDY_DIRECTOR

Pierre Fabre Laboratories

Study Locations (Sites)

University of California Los Angeles (UCLA) (Adults and Pediatrics)

Los Angeles, California, 90095

United States

Children's Hospital of Orange County (Pediatrics [up to 25 years old])

Orange, California, 92868

United States

Lucile Packard Children's Hospital Stanford (Pediatrics only)

Palo Alto, California, 94304

United States

University of California Davis Comprehensive Cancer Center (Adults and Pediatrics)

Sacramento, California, 95817

United States

Sylvester Comprehensive Cancer Center/ University of Miami

Miami, Florida, 33136

United States

Moffit Cancer Center (Adults only)

Tampa, Florida, 33612

United States

Children's Healthcare of Atlanta (Pediatrics only [up to 25 years old])

Atlanta, Georgia, 30322

United States

Emory University/Winship Cancer Institute (Adults [>= 16 years])

Atlanta, Georgia, 30322

United States

Ann & Robert H. Lurie Children's Hospital of Chicago (Pediatrics only)

Chicago, Illinois, 60611

United States

University of Maryland Medical Center (Adults only)

Baltimore, Maryland, 21201

United States

Dana Farber Cancer Institute (DFCI) (Adults and Pediatrics)

Boston, Massachusetts, 02215

United States

University of Michigan Rogel Cancer Center (Adults and Pediatrics)

Ann Arbor, Michigan, 48109

United States

University of Minnesota (Adults only)

Minneapolis, Minnesota, 55455

United States

Washington University in St. Louis (Adults only)

St Louis, Missouri, 63108

United States

Columbia University Irving Medical Center (Adults only)

New York, New York, 10032

United States

Memorial Sloan-Kettering Cancer Center (Adults and Pediatrics)

New York, New York, 10065

United States

The Children's Hospital at Montefiore (Adults and Pediatrics)

The Bronx, New York, 10467

United States

Cleveland Clinic Taussig Cancer Center (Adults and Pediatrics)

Cleveland, Ohio, 44195

United States

The Ohio State University - The James Cancer Hospital and Solove Research Institute (Adults only)

Columbus, Ohio, 43210

United States

Oregon Health and Science University (Adults and Pediatrics)

Portland, Oregon, 97239

United States

Medical University of South Carolina (Adults and Pediatrics)

Charleston, South Carolina, 29425

United States

University of Texas Southwestern Medical Center (Pediatrics only)

Dallas, Texas, 75390

United States

MD Anderson (Adults and Pediatrics)

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Pierre Fabre Medicament

Anke Friedetzky, STUDY_DIRECTOR, Pierre Fabre Laboratories

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-07-14

Study Completion Date2028-05

Study Record Updates

Study Start Date2021-07-14

Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

Allogeneic, Off-The-Shelf T-cell Immunotherapy
Epstein-Barr Virus (EBV)
Epstein-Barr Virus-specific Cytotoxic T lymphocyte (EBV-CTL)
Solid Organ Transplant (SOT)
Hematopoietic Cell Transplant (HCT)
EBVision

Additional Relevant MeSH Terms

Epstein-Barr Virus (EBV)-Associated Diseases
EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD)
EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
EBV+ Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
Solid Organ Transplant Complications
Lymphoproliferative Disorders
Allogeneic Hematopoietic Cell Transplant
Stem Cell Transplant Complications
EBV+ Sarcomas
Leiomyosarcoma