A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy

Part of paid clinical trials in Duarte, California.

Sponsor
Pierre Fabre Medicament
Study ID
NCT03394365
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • tabelecleucel — BIOLOGICAL
    Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.

Study Details

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.

Key Dates

Start date
Dec 29, 2017
Status verified
May 2026
Primary completion
May 31, 2030
Completion
Aug 31, 2030

Study Design

Enrollment
115 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort SOT-R (C-SOT-R)
    Participants with EBV+ PTLD following SOT that has failed rituximab will receive IV tabelecleucel.
  • Experimental: Cohort SOT-R+C (C-SOT-R+C)
    Participants with EBV+ PTLD following SOT that has failed both rituximab and chemotherapy will receive IV tabelecleucel.
  • Experimental: Cohort HCT (C-HCT)
    Participants with EBV+ PTLD following HCT that has failed rituximab containing regimen will receive IV tabelecleucel.

Primary Outcome Measure

Objective Response Rate (ORR) in the Analysis Cohorts C-SOT, C-HCT, and Combined Population (C-SOT-R+C, C-SOT-R-Ci, and C-HCT) Who Received Commercial Product, or a Product Manufactured Using a Comparable PV [ Time Frame: 2 years ]

Central Contacts

Locations (40)

FacilityCityStateZIPSite coordinators
City of Hope (Adults and Pediatrics)DuarteCalifornia91010-
University of California San Diego Moores Cancer Center (Adults only)La JollaCalifornia92093-
Loma Linda University Medical Center (Adults only)Loma LindaCalifornia92354
Aditya Sharma, MD
1 (909) 558-4910
Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)Los AngelesCalifornia90027
Amber Medina
323-361-5654
Neena Kapoor, MD
323-361-2434
UCLA Medical Center (Adults and Pediatrics)Los AngelesCalifornia90095-
University of California Davis Comprehensive Cancer Center (Adults only)SacramentoCalifornia95817-
Yale University (Adults and Pediatrics)New HavenConnecticut06519-
MedStar Georgetown University Hospital (Adults and Pediatrics)Washington D.C.District of Columbia20007
Udeme Ekong, MD
202-444-3514
University of Florida (Adults and Pediatrics)GainesvilleFlorida32610-
University of Miami/Jackson Memorial Hospital (Adults only)MiamiFlorida33136
Amer Beitinjaneh, MD, MPH, MSc
1 (305) 243-9848
Arthur M. Blank Hospital (Pediatrics)AtlantaGeorgia30329
Suhag Parikh, MD
1 (404) 727-8930
Winship Cancer Institute (Adults only)AtlantaGeorgia30322-
Ann & Robert H. Lurie Children's Hospital of Chicago (Adults and Pediatrics)ChicagoIllinois60611
Sonali Chaudhury, MD
312-227-4090
University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)ChicagoIllinois60637-
Loyola University Medical Center (Adults and Pediatrics)MaywoodIllinois60153
Patrick Hagen, MD
1 (708) 327-2241
University of Maryland School of Medicine (Adults only)BaltimoreMaryland21201-
Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)BostonMassachusetts02215
Sarah Nikiforow, MD
617-632-6640
Washington University School of Medicine (Adults only)St LouisMissouri63110
Armin Ghobadi, MD
(314) 747-8439
Columbia University Medical Center (Adults and Pediatrics)New YorkNew York10032-
Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)New YorkNew York10065-
Weill Cornell Medicine (Adults only)New YorkNew York10021-
Montefiore Medical Center (Adults only)The BronxNew York10467-
Montefiore Medical Center (Pediatrics only)The BronxNew York10467-
University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)Chapel HillNorth Carolina27599-
Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)CharlotteNorth Carolina28204
Michael Kent, MD
704-381-9900
Duke Cancer Institute (Adults and Pediatrics)DurhamNorth Carolina27710
Matthew McKinney, MD
1 (919) 684-8111
Cleveland Clinic Foundation (Adults and Pediatrics)ClevelandOhio44195
Rabi Hanna, MD
1 (216) 444-0663
Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics)ColumbusOhio43210
Robert Baiocchi, MD, PhD
(614) 293-3196
Nationwide Children's Hospital (Pediatrics only)ColumbusOhio43205-
Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)PortlandOregon97239
Andy Chen, MD
1 (503) 494-5058
Hospital of the University of Pennsylvania (Adults only)PhiladelphiaPennsylvania19104
Sunita Nasta, MD
215-662-6933
The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics)PhiladelphiaPennsylvania19104
Caitlin Elgarten, MD
1 267-425-7964
University of Pittsburgh Medical Center (Adults only)PittsburghPennsylvania15232-
Medical University of South Carolina (Adults and Pediatrics)CharlestonSouth Carolina29425-
Saint Jude Children's Research Hospital (Pediatrics only)MemphisTennessee38105-
Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)NashvilleTennessee37232
Bhagirathbhai Dholaria, MD
1 (615) 875-3112
Baylor Scott and White Research Institute (Adults only)DallasTexas75246
Luis Pineiro, MD
214-370-1000
University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)DallasTexas75390
Tamra Slone, MD
1 (214) 648-3150
MD Anderson Cancer Center (Pediatrics and Adult)HoustonTexas77030
Priti Tewari, MD
1 713-632-5087
Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only)MilwaukeeWisconsin53226-

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City of Hope (Adults and Pediatrics)· Duarte, CAUniversity of California San Diego Moores Cancer Center (Adults only)· La Jolla, CALoma Linda University Medical Center (Adults only)· Loma Linda, CAChildren's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)· Los Angeles, CAUCLA Medical Center (Adults and Pediatrics)· Los Angeles, CAUniversity of California Davis Comprehensive Cancer Center (Adults only)· Sacramento, CA

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