Back to resultsTabelecleucel 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 (ALLELE)
Primary Purpose
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tabelecleucel
Sponsored by
About this trial
This is an interventional treatment trial for Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD) focused on measuring 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
Eligibility Criteria
Inclusion Criteria:
- Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (SOT cohort); or prior allogeneic HCT (HCT cohort)
- A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD
- Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor
- 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.
- Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (SOT subgroup A or HCT cohort) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (SOT subgroup B) for treatment of PTLD.
- Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged ≥ 16 years; Lansky score ≥ 20 for subjects < 16 years
- For HCT cohort 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
Adequate organ function
- Absolute neutrophil count ≥ 1000/μL, (SOT cohort) or ≥ 500/μL (HCT cohort), with or without cytokine support
- Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For HCT cohort, 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)
- 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
- Subject or subject's representative is willing and able to provide written informed consent
Exclusion Criteria:
- Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma
- Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis
- 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.
- 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
- 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
- For HCT cohort: active adenovirus viremia
- Need for vasopressor or ventilatory support
- Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment
- Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts), or unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only)
- 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
- Inability to comply with study-related procedures
Sites / Locations
- City of Hope (Adults and Pediatrics)Recruiting
- University of California San Diego Moores Cancer Center (Adults only)
- Loma Linda University Cancer Center (Adults only)Recruiting
- Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)Recruiting
- UCLA Medical Center (Adults and Pediatrics)Recruiting
- University of California Davis Comprehensive Cancer Center (Adults only)
- Yale University (Adults and Pediatrics)Recruiting
- MedStar Georgetown University Hospital (Adults and Pediatrics)Recruiting
- University of Florida (Adults and Pediatrics)
- University of Miami/Jackson Memorial Hospital (Adults only)Recruiting
- Children's Healthcare of Atlanta at Egleston (Pediatrics)Recruiting
- Winship Cancer Institute of Emory University (Adults only)Recruiting
- Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)Recruiting
- University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)Recruiting
- Loyola University Medical Center (Adults and Pediatrics)Recruiting
- University of Maryland School of Medicine (Adults only)Recruiting
- Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)Recruiting
- Washington University School of Medicine (Adults only)Recruiting
- Montefiore Medical Center (Adults only)
- Montefiore Medical Center (Pediatrics only)
- Weill Cornell Medicine (Adults only)Recruiting
- Columbia University Medical Center (Adults and Pediatrics)Recruiting
- Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)Recruiting
- University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)
- Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)Recruiting
- Duke Cancer Institute (Adults only)Recruiting
- Cleveland Clinic Foundation (Adults and Pediatrics)Recruiting
- Nationwide Children's Hospital (Pediatrics only)
- The Ohio State University - Arthur G. James Cancer Center Hospital (Adults and Pediatrics)Recruiting
- Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)Recruiting
- Children's Hospital of Philadelphia (Pediatrics only)Recruiting
- University of Pennsylvania (Adults only)
- University of Pittsburgh Medical Center (Adults only)
- Medical University of South Carolina (Adults and Pediatrics)Recruiting
- Saint Jude Children's Research Hospital (Pediatrics only)
- Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)Recruiting
- Baylor Scott and White Research Institute (Adults only)Recruiting
- University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)Recruiting
- MD Anderson Cancer Center (Adults and Pediatrics)Recruiting
- Froedtert Hospital & the Medical College of Wisconsin (Adults only)
- The Children's Hospital at Westmead (Pediatrics only)Recruiting
- Westmead Hospital (Adults only)Recruiting
- The Prince Charles Hospital (Adults only)Recruiting
- Royal Adelaide Hospital (Adults only)Recruiting
- The Royal Children's Hospital Melbourne (Pediatrics only)Recruiting
- Fiona Stanley Hospital (Adults only)Recruiting
- Medizinische Universitat Wien (Adults only)Recruiting
- Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)Recruiting
- Universitair Ziekenhuis Leuven (Adults and Pediatrics)Recruiting
- Alberta Children's Hospital (Adults and Pediatrics)Recruiting
- Sick Kids (Pediatrics only)Recruiting
- Princess Margaret Cancer Centre (Adults only)Recruiting
- Groupe Hospitalier du Haut Leveque (Adults only)Recruiting
- Hôpital Saint Antoine (Adults only)Recruiting
- Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)Recruiting
- Hôpital Necker-Enfants Malades (Pediatrics only)Recruiting
- Hôpital Universitaire Pitié Salpêtrière (Adults only)Recruiting
- Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)Recruiting
- Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli (Adults only)Recruiting
- Ospedale Pediatrico Bambino Gesu (Pediatrics only)Recruiting
- Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)Recruiting
- Hospital Duran i ReynalsRecruiting
- Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)Recruiting
- Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)Recruiting
- Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)Recruiting
- University Hospital Virgen del Rocio (Adults and Pediatrics)Recruiting
- Hospital Universitario La Fe (Adults and Pediatrics)Recruiting
- University Hospitals Birmingham NHS Foundation Trust (Adults only)Recruiting
- King's College Hospital NHS Foundation Trust (Adults only)Recruiting
- Imperial College Healthcare NHS Trust (Adults only)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
SOT cohort -Subgroup A
SOT cohort -Subgroup B
HCT cohort
Arm Description
Participants who have failed rituximab will receive IV tabelecleucel.
Participants who have failed both rituximab and chemotherapy will receive IV tabelecleucel.
Participants who have failed rituximab will receive IV tabelecleucel.
Outcomes
Primary Outcome Measures
Objective response rate (ORR) in the SOT or HCT cohort
Secondary Outcome Measures
Duration of response (DOR) in SOT and HCT cohorts separately
ORR and DOR in SOT and HCT cohorts combined
Rates of complete response (CR) and partial response (PR)
Time to response
Time to best response
Overall survival (OS)
Rates of allograft loss or rejection episodes (SOT cohort)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03394365
Brief Title
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
Acronym
ALLELE
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2017 (Actual)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atara Biotherapeutics
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 and rituximab plus chemotherapy or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.
Detailed Description
This is a multicenter, open-label, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of SOT after failure of rituximab and rituximab plus chemotherapy (SOT cohort) or HCT after failure of rituximab (HCT cohort).
Enrollment will be preceded by confirmation of availability of partially human leukocyte antigen (HLA) matched and restricted tabelecleucel for the participant.
Study procedures and product administration will be the same for each cohort. Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle, participants will receive intravenous tabelecleucel at a dose of 2×10^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35. Treatment will continue until maximal response, unacceptable toxicity, initiation of non protocol therapy, or failure of tabelecleucel with up to 2 different HLA restrictions (SOT cohort) or up to 4 different HLA restrictions (HCT cohort). The study includes a total of 5 years of follow-up for disease and survival status.
This protocol has been amended to include the HCT cohort from clinical study ATA129-EBV-301 (NCT03392142).
NOTE, 29 April 2020: Enrollment is temporarily paused at study site/locations with status "active, not recruiting" due to COVID-19 restrictions.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant, Stem Cell Transplant Complications
Keywords
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SOT cohort -Subgroup A
Arm Type
Experimental
Arm Description
Participants who have failed rituximab will receive IV tabelecleucel.
Arm Title
SOT cohort -Subgroup B
Arm Type
Experimental
Arm Description
Participants who have failed both rituximab and chemotherapy will receive IV tabelecleucel.
Arm Title
HCT cohort
Arm Type
Experimental
Arm Description
Participants who have failed rituximab will receive IV tabelecleucel.
Intervention Type
Biological
Intervention Name(s)
tabelecleucel
Other Intervention Name(s)
tab-cel®, ATA129, EBV-CTL
Intervention Description
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
Primary Outcome Measure Information:
Title
Objective response rate (ORR) in the SOT or HCT cohort
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Duration of response (DOR) in SOT and HCT cohorts separately
Time Frame
2 years
Title
ORR and DOR in SOT and HCT cohorts combined
Time Frame
2 years
Title
Rates of complete response (CR) and partial response (PR)
Time Frame
2 years
Title
Time to response
Time Frame
2 years
Title
Time to best response
Time Frame
2 years
Title
Overall survival (OS)
Time Frame
2 years
Title
Rates of allograft loss or rejection episodes (SOT cohort)
Time Frame
2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (SOT cohort); or prior allogeneic HCT (HCT cohort)
A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD
Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor
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.
Treatment failure of rituximab or interchangeable commercially available biosimilar monotherapy (SOT subgroup A or HCT cohort) or rituximab plus any concurrent or sequentially administered chemotherapy regimen (SOT subgroup B) for treatment of PTLD.
Eastern Cooperative Oncology Group performance status ≤ 3 for subjects aged ≥ 16 years; Lansky score ≥ 20 for subjects < 16 years
For HCT cohort 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
Adequate organ function
Absolute neutrophil count ≥ 1000/μL, (SOT cohort) or ≥ 500/μL (HCT cohort), with or without cytokine support
Platelet count ≥ 50,000/μL, with or without transfusion or cytokine support. For HCT cohort, 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)
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
Subject or subject's representative is willing and able to provide written informed consent
Exclusion Criteria:
Burkitt lymphoma, classical Hodgkin lymphoma, or any T cell lymphoma
Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or extracorporeal photopheresis
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.
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
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
For HCT cohort: active adenovirus viremia
Need for vasopressor or ventilatory support
Antithymocyte globulin or similar anti-T cell antibody therapy ≤ 4 weeks prior to enrollment
Treatment with Epstein-Barr virus cytotoxic T lymphocytes or chimeric antigen receptor T cells directed against B cells within 8 weeks of enrollment (SOT or HCT cohorts), or unselected donor lymphocyte infusion within 8 weeks of enrollment (HCT cohort only)
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
Inability to comply with study-related procedures
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aditi Mehta, DO
Phone
650-278-8930
Ext
1
Email
clinicalstudies@atarabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aditi Mehta, DO
Organizational Affiliation
Atara Biotherapeutics
Official's Role
Study Director
Facility Information:
Facility Name
City of Hope (Adults and Pediatrics)
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amandeep Salhotra, MD
Phone
626-256-4673
Email
asalhotra@coh.org
Facility Name
University of California San Diego Moores Cancer Center (Adults only)
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Loma Linda University Cancer Center (Adults only)
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huynh Cao, MD
Phone
909-558-1000
Email
hcao@llu.edu
Facility Name
Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neena Kapoor, MD
Phone
323-361-2434
Email
nkapoor@chla.usc.edu
Facility Name
UCLA Medical Center (Adults and Pediatrics)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Herbert Eradat, MD
Phone
310-633-8400
Email
heradat@mednet.ucla.edu
Facility Name
University of California Davis Comprehensive Cancer Center (Adults only)
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Individual Site Status
Completed
Facility Name
Yale University (Adults and Pediatrics)
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Asch, MD
Phone
203-785-4184
Email
william.asch@yale.edu
Facility Name
MedStar Georgetown University Hospital (Adults and Pediatrics)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Udeme Ekong, MD
Phone
202-444-3514
Email
udeme.d.ekong@gunet.georgetown.edu
Facility Name
University of Florida (Adults and Pediatrics)
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Completed
Facility Name
University of Miami/Jackson Memorial Hospital (Adults only)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amer Beitinjaneh, MD, MPH, MSc
Phone
305-243-9848
Email
abeitinjaneh@miami.edu
Facility Name
Children's Healthcare of Atlanta at Egleston (Pediatrics)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322-1060
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Suhag Parikh, MD
Phone
404-727-8930
Email
suhag.parikh@emory.edu
Facility Name
Winship Cancer Institute of Emory University (Adults only)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Koff, MD
Phone
910-540-5145
Email
jkoff@emory.edu
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonali Chaudhury, MD
Phone
312-227-4090
Email
schaudhury@luriechildrens.org
Facility Name
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Satayaijt Kosuri, MD
Phone
773-702-7540
Email
skosuri@medicine.bsd.uchicago.edu
Facility Name
Loyola University Medical Center (Adults and Pediatrics)
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick Hagen, MD
Phone
708-327-2241
Email
Patrick.hagen@lumc.edu
Facility Name
University of Maryland School of Medicine (Adults only)
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean Yared, MD
Phone
410-328-1230
Email
jyared@umm.edu
Facility Name
Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Nikiforow, MD
Phone
617-632-6640
Email
sarah_nikiforow@dfci.harvard.edu
Facility Name
Washington University School of Medicine (Adults only)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Armin Ghobadi, MD
Phone
314-747-8439
Email
arminghobadi@wustl.edu
Facility Name
Montefiore Medical Center (Adults only)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Completed
Facility Name
Montefiore Medical Center (Pediatrics only)
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Completed
Facility Name
Weill Cornell Medicine (Adults only)
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Koen Van Besien, MD
Phone
212-746-2048
Email
kov9001@med.cornell.edu
Facility Name
Columbia University Medical Center (Adults and Pediatrics)
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ran Reshef, MD
Phone
212-342-0530
Email
rr3036@cumc.columbia.edu
Facility Name
Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kevin Curran, MD
Phone
212-639-5836
Email
currank@mskcc.org
Facility Name
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Completed
Facility Name
Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Kent, MD
Phone
704-381-9900
Email
Michael.kent@atriumhealth.org
Facility Name
Duke Cancer Institute (Adults only)
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matthew McKinney, MD
Phone
919-684-8111
Email
matthew.mckinney@duke.edu
Facility Name
Cleveland Clinic Foundation (Adults and Pediatrics)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hanna Rabi, MD
Phone
216-444-0663
Email
hannar2@ccf.org
Facility Name
Nationwide Children's Hospital (Pediatrics only)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Individual Site Status
Completed
Facility Name
The Ohio State University - Arthur G. James Cancer Center Hospital (Adults and Pediatrics)
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Baiocchi, MD, PhD
Phone
614-293-3196
Email
robert.baiocchi@osumc.edu
Facility Name
Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nemecek Eneida, MD
Phone
503-494-5058
Email
nemeceke@ohsu.edu
Facility Name
Children's Hospital of Philadelphia (Pediatrics only)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nancy Bunin, MD
Phone
215-590-2255
Email
buninn@email.chop.edu
Facility Name
University of Pennsylvania (Adults only)
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
University of Pittsburgh Medical Center (Adults only)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Medical University of South Carolina (Adults and Pediatrics)
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Hudspeth, MD
Phone
843-792-0381
Email
hudspeth@musc.edu
Facility Name
Saint Jude Children's Research Hospital (Pediatrics only)
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Individual Site Status
Completed
Facility Name
Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhagirathbhai Dholaria, MD
Phone
615-875-3112
Email
Bhagirathbhai.R.Dholaria@vumc.org
Facility Name
Baylor Scott and White Research Institute (Adults only)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Pineiro, MD
Phone
214-370-1000
Email
luis.pineiro@usoncology.com
Facility Name
University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tamra Slone, MD
Phone
214-648-3150
Email
tamra.slone@utsouthwestern.edu
Facility Name
MD Anderson Cancer Center (Adults and Pediatrics)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kris Michael Mahadeo, MD
Phone
713 792-2873
Email
kmmahadeo@mdanderson.org
Facility Name
Froedtert Hospital & the Medical College of Wisconsin (Adults only)
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Completed
Facility Name
The Children's Hospital at Westmead (Pediatrics only)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
James Butterworth, MD
Phone
+61 2 9845 2185
Email
caroline.bateman@health.nsw.gov.au
Facility Name
Westmead Hospital (Adults only)
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shyam Panicker, MD, MBBS, MRCP, FRACP, FRCPA
Phone
+61 (2) 9845 6352
Email
shyam.panicker@health.nsw.gov.au
Facility Name
The Prince Charles Hospital (Adults only)
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Chambers, MBBS, MRCP, FRACP, MD
Phone
+61 (7) 3139 4000
Email
daniel.chambers@health.qld.gov.au
Facility Name
Royal Adelaide Hospital (Adults only)
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Devendra Hiwase, MD
Phone
+61 870740000
Email
devendra.hiwase@sa.gov.au
Facility Name
The Royal Children's Hospital Melbourne (Pediatrics only)
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rachel Conyers, MD, MBBS, FRACP
Phone
+61 (3) 9345 5658
Email
rachel.conyers@rch.org.au
Facility Name
Fiona Stanley Hospital (Adults only)
City
Murdoch
State/Province
Western Australia
ZIP/Postal Code
6150
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Duncan Purtill, MD, MBBS, FRACP, FRCPA
Phone
+61 (8) 6152 3788
Email
duncan.purtill@health.wa.gov.au
Facility Name
Medizinische Universitat Wien (Adults only)
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Worel, MD
Phone
+43 (1) 40400 54990
Email
nina.worel@meduniwien.ac.at
Facility Name
Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)
City
Liège
State/Province
Brussels
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willems Evelyne, MD
Phone
+32 4 366 72 01
Email
e.willems@chu.ulg.ac.be
Facility Name
Universitair Ziekenhuis Leuven (Adults and Pediatrics)
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daan Dierickx, MD
Phone
+32 16 34 68 80
Email
daan.dierickx@uzleuven.be
Facility Name
Alberta Children's Hospital (Adults and Pediatrics)
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T3B 6A8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Victor Lewis, MD
Phone
1 (403) 955-7203
Email
victor.lewis@albertahealthservices.ca
Facility Name
Sick Kids (Pediatrics only)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joerg Krueger, MD
Phone
1 (416) 813-7654
Ext
208227
Email
joerg.krueger@sickkids.ca
Facility Name
Princess Margaret Cancer Centre (Adults only)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arjun Law, MD
Phone
1 (416) 315-1147
Email
arjun.law@uhn.ca
Facility Name
Groupe Hospitalier du Haut Leveque (Adults only)
City
Pessac
State/Province
Aquitaine
ZIP/Postal Code
33600
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Forcade, MD
Phone
+33 557656511
Email
edouard.forcade@chu-bordeaux.fr
Facility Name
Hôpital Saint Antoine (Adults only)
City
Paris
State/Province
Ile-de-France
ZIP/Postal Code
75571
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eolia Brissot, MD
Phone
+33 149282621
Email
eolia.brissot@sat.aphp.fr
Facility Name
Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)
City
Lille cedex
State/Province
Nord-Pas-de-Calais
ZIP/Postal Code
59037
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franck Morschhauser, MD
Phone
+33 320445962
Email
franck.morschhauser@chru-lille.fr
Facility Name
Hôpital Necker-Enfants Malades (Pediatrics only)
City
Paris 15
State/Province
Île-de-France
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benedicte Neven, MD
Phone
+33 44494822
Email
benedicte.neven@aphp.fr
Facility Name
Hôpital Universitaire Pitié Salpêtrière (Adults only)
City
Paris Cedex 13
State/Province
Île-de-France
ZIP/Postal Code
75651
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain Choquet, MD
Phone
+33 142162826
Email
sylvain.choquet@psl.aphp.fr
Facility Name
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)
City
Milano
ZIP/Postal Code
20162
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Cairoli, MD
Phone
+39 2 64441
Email
roberto.cairoli@ospedaleniguarda.it
Facility Name
Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Comoli, MD
Phone
+39 0382 502716
Email
pcomoli@smatteo.pv.it
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli (Adults only)
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Simona Sica, MD
Phone
+39 0630155300
Email
simona.sica@unicatt.it
Facility Name
Ospedale Pediatrico Bambino Gesu (Pediatrics only)
City
Roma
ZIP/Postal Code
165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franco Locatelli, MD
Phone
+390668592129
Email
franco.locatelli@opbg.net
Facility Name
Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giaccone Luisa, MD
Phone
+390116334279
Email
luisa.giaccone@unito.it
Facility Name
Hospital Duran i Reynals
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
8908
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva González-Barca, MD
Phone
+34 932274778
Email
e.gonzalez@iconcologia.net
Facility Name
Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)
City
Santander
State/Province
Cantabria
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucrecia Yanez, MD
Phone
+34 942202573
Email
lucrecia.yanez@scsalud.es
Facility Name
Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pere Barba, MD
Phone
+34 93 274 6100
Ext
4897
Email
pbarba@vhio.net
Facility Name
Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gillen Oarbeascoa, MD
Phone
+34 91 586 84 43
Email
gillen.oarbeascoa@salud.madrid.org
Facility Name
University Hospital Virgen del Rocio (Adults and Pediatrics)
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Perez-Simon, MD
Phone
34-955 013260
Email
josea.perez.simon.sspa@juntadeandalucia.es
Facility Name
Hospital Universitario La Fe (Adults and Pediatrics)
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Montoro, MD
Phone
+34 961 245 876
Email
juanmontorogomez@gmail.com
Facility Name
University Hospitals Birmingham NHS Foundation Trust (Adults only)
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2GW
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sridhar Chaganti, MD
Phone
441214242000
Email
sridhar.chaganti@uhb.nhs.uk
Facility Name
King's College Hospital NHS Foundation Trust (Adults only)
City
London
State/Province
England
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Avenoso, MD
Phone
+02032999000
Ext
32084
Email
d.avenoso@nhs.net
Facility Name
Imperial College Healthcare NHS Trust (Adults only)
City
London
State/Province
England
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eduardo Olavarria, MD
Phone
+44 0208 383 2134
Email
e.olavarria@nhs.net
12. IPD Sharing Statement
Plan to Share IPD
No
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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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