RECRUITING

Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Participants with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy

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Conditions

Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)Solid Organ Transplant ComplicationsLymphoproliferative DisordersAllogeneic Hematopoietic Cell TransplantStem Cell Transplant ComplicationsEpstein-Barr Virus (EBV)-associated Lymphoproliferative Disease (LPD)Epstein-Barr Virus (EBV)Cytotoxic T lymphocyte (CTL)Cancer After TransplantKidney transplantRenal transplantLiver transplantHeart transplantLung transplantIntestinal transplantPancreas transplantPost-transplant LymphomaSolid Organ Transplant (SOT)Bone Marrow Transplant ComplicationsEpstein-Barr Virus-specific Cytotoxic T Lymphocytes (EBV-CTL)Hematopoietic Cell Transplant (HCT)Hematopoietic Stem Cell Transplantation (HSCT)Allogeneic, Off-The-Shelf T-cell Immunotherapy

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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 determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.

Official Title

Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Solid Organ or Allogeneic Hematopoietic Cell Transplant Subjects with Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab or Rituximab and Chemotherapy

Quick Facts

Study Start:2017-12-29
Study Completion:2027-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03394365

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 CriteriaExclusion Criteria
  1. 1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (C-SOT); or prior allogeneic HCT (C-HCT)
  2. 2. A diagnosis of locally assessed, biopsy-proven EBV+ PTLD
  3. 3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor
  4. 4. Measurable, 18F-deoxyglucose (FDG)-avid (Deauville score ≥ 3) systemic disease using Lugano Classification response criteria by positron emission tomography (PET)-diagnostic computed tomography (CT), except when contraindicated or mandated by local practice, then magnetic resonance imaging (MRI) may be used. For subjects with treated central nervous system (CNS) disease, a head CT and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.
  5. 5. Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (C-SOT-R or C-HCT) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (C-SOT-R+C) for treatment of PTLD.
  6. 6. Males and females of any age.
  7. 7. Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged ≥ 16 years; Lansky score ≥ 20 for subjects \< 16 years
  8. 8. For C-HCT only: If allogeneic HCT was performed as treatment for an acute lymphoid or myeloid malignancy, the underlying primary disease for which the subject underwent transplant must be in morphologic remission
  9. 9. Adequate organ function
  10. 1. Absolute neutrophil count ≥ 1000/μL, (C-SOT) or ≥ 500/μL (C-HCT), with or without cytokine support
  11. 2. Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For C-HCT, platelet count \< 50,000/μL but ≥ 20,000/μL, with or without transfusion support, is permissible if the subject has not had grade ≥ 2 bleeding in the prior 4 weeks (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\], version 5.0)
  12. 3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin each \< 5 × the upper limit of normal; however, ALT, AST, and total bilirubin each ≤ 10 × upper limit of normal is acceptable if the elevation is considered by the investigator to be due to EBV and/or PTLD involvement of the liver as long as there is no known evidence of significant liver dysfunction
  13. 10. Subject or subject's representative is willing and able to provide written informed consent
  1. 1. Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma
  2. 2. Daily steroids of \> 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis
  3. 3. Untreated CNS PTLD or CNS PTLD for which the subject is actively receiving CNS-directed chemotherapy (systemic or intrathecal) or radiotherapy at enrollment. NOTE:Subjects with previously treated CNS PTLD may enroll if CNS-directed therapy is complete.
  4. 4. Suspected or confirmed grade ≥ 2 graft-versus-host disease (GvHD) per the Center for International Blood and Marrow Transplant Research consensus grading system at enrollment
  5. 5. Ongoing or recent use of a checkpoint inhibitor agent (eg, ipilimumab, pembrolizumab, nivolumab) within 3 drug half-lives from the most recent dose to enrollment
  6. 6. For C-HCT: active adenovirus viremia
  7. 7. Need for vasopressor or ventilatory support
  8. 8. Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment
  9. 9. Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (C-SOT or C-HCT), or unselected donor lymphocyte infusion within 8 weeks of enrollment (C-HCT only)
  10. 10. Female who is breastfeeding or pregnant or female of childbearing potential or male with a female partner of childbearing potential unwilling to use a highly effective method of contraception
  11. 11. Inability to comply with study-related procedures
  12. 12. Any medical condition or organ system dysfunction that in the investigator\'s opinion, could compromise the participant\'s safety or ability to complete the study

Contacts and Locations

Study Contact

Aditi Mehta, DO
CONTACT
650-278-8930
clinicalstudies@atarabio.com

Principal Investigator

Aditi Mehta, DO
STUDY_DIRECTOR
Atara Biotherapeutics

Study Locations (Sites)

City of Hope (Adults and Pediatrics)
Duarte, California, 91010
United States
University of California San Diego Moores Cancer Center (Adults only)
La Jolla, California, 92093
United States
Loma Linda University Medical Center (Adults only)
Loma Linda, California, 92354
United States
Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)
Los Angeles, California, 90027
United States
UCLA Medical Center (Adults and Pediatrics)
Los Angeles, California, 90095
United States
University of California Davis Comprehensive Cancer Center (Adults only)
Sacramento, California, 95817
United States
Yale University (Adults and Pediatrics)
New Haven, Connecticut, 06519
United States
MedStar Georgetown University Hospital (Adults and Pediatrics)
Washington, District of Columbia, 20007
United States
University of Florida (Adults and Pediatrics)
Gainesville, Florida, 32610
United States
University of Miami/Jackson Memorial Hospital (Adults only)
Miami, Florida, 33136
United States
Children's Healthcare of Atlanta at Egleston (Pediatrics)
Atlanta, Georgia, 30322-1060
United States
Winship Cancer Institute (Adults only)
Atlanta, Georgia, 30322
United States
Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)
Chicago, Illinois, 60611
United States
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)
Chicago, Illinois, 60637
United States
Loyola University Medical Center (Adults and Pediatrics)
Maywood, Illinois, 60153
United States
University of Maryland School of Medicine (Adults only)
Baltimore, Maryland, 21201
United States
Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)
Boston, Massachusetts, 02215
United States
Washington University School of Medicine (Adults only)
Saint Louis, Missouri, 63110
United States
Montefiore Medical Center (Adults only)
Bronx, New York, 10467
United States
Montefiore Medical Center (Pediatrics only)
Bronx, New York, 10467
United States
Weill Cornell Medicine (Adults only)
New York, New York, 10021
United States
Columbia University Medical Center (Adults and Pediatrics)
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)
New York, New York, 10065
United States
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)
Chapel Hill, North Carolina, 27599
United States
Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)
Charlotte, North Carolina, 28204
United States
Duke Cancer Institute (Adults only)
Durham, North Carolina, 27710
United States
Cleveland Clinic Foundation (Adults and Pediatrics)
Cleveland, Ohio, 44195
United States
Nationwide Children's Hospital (Pediatrics only)
Columbus, Ohio, 43205
United States
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics)
Columbus, Ohio, 43210
United States
Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)
Portland, Oregon, 97239
United States
Hospital of the University of Pennsylvania (Adults only)
Philadelphia, Pennsylvania, 19104
United States
The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics)
Philadelphia, Pennsylvania, 19104
United States
University of Pittsburgh Medical Center (Adults only)
Pittsburgh, Pennsylvania, 15232
United States
Medical University of South Carolina (Adults and Pediatrics)
Charleston, South Carolina, 29425
United States
Saint Jude Children's Research Hospital (Pediatrics only)
Memphis, Tennessee, 38105
United States
Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)
Nashville, Tennessee, 37232
United States
Baylor Scott and White Research Institute (Adults only)
Dallas, Texas, 75246
United States
University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)
Dallas, Texas, 75390
United States
MD Anderson Cancer Center (Pediatrics and Adult)
Houston, Texas, 77030
United States
Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only)
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Atara Biotherapeutics

  • Aditi Mehta, DO, STUDY_DIRECTOR, Atara Biotherapeutics

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 Date2017-12-29
Study Completion Date2027-06

Study Record Updates

Study Start Date2017-12-29
Study Completion Date2027-06

Terms related to this study

Keywords Provided by Researchers

  • Epstein-Barr Virus (EBV)-associated Lymphoproliferative Disease (LPD)
  • Epstein-Barr Virus (EBV)
  • Cytotoxic T lymphocyte (CTL)
  • Cancer After Transplant
  • Kidney transplant
  • Renal transplant
  • Liver transplant
  • Heart transplant
  • Lung transplant
  • Intestinal transplant
  • Pancreas transplant
  • Post-transplant Lymphoma
  • Solid Organ Transplant (SOT)
  • Bone Marrow Transplant Complications
  • Epstein-Barr Virus-specific Cytotoxic T Lymphocytes (EBV-CTL)
  • Hematopoietic Cell Transplant (HCT)
  • Hematopoietic Stem Cell Transplantation (HSCT)
  • Allogeneic Hematopoietic Cell Transplant
  • Allogeneic, Off-The-Shelf T-cell Immunotherapy

Additional Relevant MeSH Terms

  • Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
  • Solid Organ Transplant Complications
  • Lymphoproliferative Disorders
  • Allogeneic Hematopoietic Cell Transplant
  • Stem Cell Transplant Complications