Actively Recruiting

Phase 3
All Genders
ID03394365

Phase 3 Study of Tabelecleucel for Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease Following Solid Organ or Hematopoietic Cell Transplant After Rituximab Failure

Led by Pierre Fabre Medicament · Updated on 2026-05-22

115

Participants Needed

71

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating tabelecleucel, an off-the-shelf allogeneic T-cell immunotherapy, for treating Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in patients who have undergone solid organ transplant (SOT) or allogeneic hematopoietic cell transplant (HCT) and have not responded to rituximab or rituximab plus chemotherapy. This phase 3, multicenter, open-label study aims to determine the clinical benefit and safety profile of tabelecleucel in these specific patient populations. Participants are divided into cohorts based on transplant type and prior treatments: those with EBV+ PTLD after SOT who failed rituximab alone (with or without chemotherapy), and those with EBV+ PTLD after HCT who failed rituximab. Tabelecleucel is given intravenously in 5-week cycles at a dose of 2 x 10^6 cells/kg on Days 1, 8, and 15, followed by observation until Day 35. Treatment continues until maximal response, unacceptable toxicity, start of other therapy, or failure of tabelecleucel, with limits on the number of different HLA restrictions tested per cohort. Participants undergo extensive assessments including biopsy confirmation, PET-CT or MRI imaging for disease evaluation, and organ function tests. Follow-up for disease and survival status lasts up to 5 years for early enrollees and up to 12 months for others and responders. The primary outcome measured is the objective response rate, with secondary outcomes including duration of response, overall survival, and rates of graft loss or rejection. Safety and efficacy are carefully monitored throughout the study duration.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Prior solid organ transplant (kidney, liver, heart, lung, pancreas, small bowel, or combination) or prior allogeneic hematopoietic cell transplant.
  • Diagnosis of biopsy-confirmed Epstein-Barr virus-positive post-transplant lymphoproliferative disease.
  • Availability of partially HLA-matched and restricted tabelecleucel confirmed.
  • Measurable systemic disease with PET-CT or MRI imaging per Lugano Classification criteria.
  • Treatment failure of rituximab alone or rituximab plus chemotherapy for PTLD.
  • Males and females of any age.
  • Eastern Cooperative Oncology Group performance status 3 or less for those 16 years and older; Lansky score 20 or higher for those under 16.
  • For hematopoietic cell transplant patients treated for acute leukemia, underlying disease must be in remission.
  • Adequate organ function including specified neutrophil and platelet counts and liver enzyme limits.
  • Willingness and ability to provide informed consent.
Not Eligible

You will not qualify if you...

  • Active aggressive lymphomas or other malignancies requiring systemic therapy.
  • Use of high-dose daily steroids over 0.5 mg/kg prednisone or equivalent, ongoing methotrexate, or extracorporeal photopheresis.
  • Untreated or actively treated central nervous system PTLD.
  • Grade 2 or higher graft-versus-host disease at enrollment.
  • Recent use of checkpoint inhibitors within three drug half-lives.
  • Active adenovirus infection for hematopoietic cell transplant patients.
  • Need for vasopressor or ventilatory support.
  • Recent anti-T cell antibody therapy within 4 weeks.
  • Recent treatment with EBV cytotoxic T cells, CAR T cells, or donor lymphocyte infusion within 8 weeks.
  • Female participants who are pregnant or breastfeeding or with inadequate contraception; male participants with partners of childbearing potential not using effective contraception.
  • Inability to comply with study procedures.
  • Any medical condition or organ dysfunction that could compromise safety or study completion as judged by the investigator.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Repeated 5-week cycles until maximal response, unacceptable toxicity, initiation of non-protocol therapy, or treatment failure

Participants receive intravenous tabelecleucel on Days 1, 8, and 15 of each 5-week cycle. Treatment continues until maximal response, unacceptable toxicity, initiation of non-protocol therapy, or failure of tabelecleucel.

3 visits per cycle (in-person on Days 1, 8, and 15) plus observation through Day 35

Follow-up

Duration - Up to 5 years depending on enrollment date and response status

Participants are followed for disease and survival status with visits every 3 months up to 12 months after treatment or for responders, 12 months from initial response.

Quarterly visits up to 12 months or 12 months from initial response

Trial Site Locations

Total: 71 locations

1

City of Hope (Adults and Pediatrics)

Duarte, California, United States, 91010

Completed

2

University of California San Diego Moores Cancer Center (Adults only)

La Jolla, California, United States, 92093

Completed

3

Loma Linda University Medical Center (Adults only)

Loma Linda, California, United States, 92354

Actively Recruiting

4

Children's Hospital Los Angeles, Div. of Research Immunology/BMT (Adults and Pediatrics)

Los Angeles, California, United States, 90027

Actively Recruiting

5

UCLA Medical Center (Adults and Pediatrics)

Los Angeles, California, United States, 90095

Completed

6

University of California Davis Comprehensive Cancer Center (Adults only)

Sacramento, California, United States, 95817

Completed

7

Yale University (Adults and Pediatrics)

New Haven, Connecticut, United States, 06519

Completed

8

MedStar Georgetown University Hospital (Adults and Pediatrics)

Washington D.C., District of Columbia, United States, 20007

Actively Recruiting

9

University of Florida (Adults and Pediatrics)

Gainesville, Florida, United States, 32610

Completed

10

University of Miami/Jackson Memorial Hospital (Adults only)

Miami, Florida, United States, 33136

Actively Recruiting

11

Winship Cancer Institute (Adults only)

Atlanta, Georgia, United States, 30322

Completed

12

Arthur M. Blank Hospital (Pediatrics)

Atlanta, Georgia, United States, 30329

Actively Recruiting

13

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

Chicago, Illinois, United States, 60611

Actively Recruiting

14

University of Chicago Medical Center - Duchossois Center for Advanced Medicine (Adults only)

Chicago, Illinois, United States, 60637

Completed

15

Loyola University Medical Center (Adults and Pediatrics)

Maywood, Illinois, United States, 60153

Actively Recruiting

16

University of Maryland School of Medicine (Adults only)

Baltimore, Maryland, United States, 21201

Completed

17

Dana Farber Cancer Institute, Brigham and Women's Hospital (Adults and Pediatrics)

Boston, Massachusetts, United States, 02215

Actively Recruiting

18

Washington University School of Medicine (Adults only)

St Louis, Missouri, United States, 63110

Actively Recruiting

19

Weill Cornell Medicine (Adults only)

New York, New York, United States, 10021

Completed

20

Columbia University Medical Center (Adults and Pediatrics)

New York, New York, United States, 10032

Completed

21

Memorial Sloan Kettering Cancer Center (Adults and Pediatrics)

New York, New York, United States, 10065

Completed

22

Montefiore Medical Center (Adults only)

The Bronx, New York, United States, 10467

Completed

23

Montefiore Medical Center (Pediatrics only)

The Bronx, New York, United States, 10467

Completed

24

University of North Carolina at Chapel Hill, Lineberger Comprehensive Cancer Center (Adults and Pediatrics)

Chapel Hill, North Carolina, United States, 27599

Completed

25

Carolinas Medical Center/Levine Children's Hospital (Adults and Pediatrics)

Charlotte, North Carolina, United States, 28204

Actively Recruiting

26

Duke Cancer Institute (Adults and Pediatrics)

Durham, North Carolina, United States, 27710

Actively Recruiting

27

Cleveland Clinic Foundation (Adults and Pediatrics)

Cleveland, Ohio, United States, 44195

Actively Recruiting

28

Nationwide Children's Hospital (Pediatrics only)

Columbus, Ohio, United States, 43205

Completed

29

Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (Adults and Pediatrics)

Columbus, Ohio, United States, 43210

Actively Recruiting

30

Oregon Health and Science University Physicians Pavilion (Adults and Pediatrics)

Portland, Oregon, United States, 97239

Actively Recruiting

31

Hospital of the University of Pennsylvania (Adults only)

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

32

The Children's Hospital of Philadelphia Oncology Division, Blood & Marrow Transplant Section (Pediatrics)

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

33

University of Pittsburgh Medical Center (Adults only)

Pittsburgh, Pennsylvania, United States, 15232

Completed

34

Medical University of South Carolina (Adults and Pediatrics)

Charleston, South Carolina, United States, 29425

Completed

35

Saint Jude Children's Research Hospital (Pediatrics only)

Memphis, Tennessee, United States, 38105

Completed

36

Vanderbilt University Medical Center Henry-Joyce Cancer Clinic (Adults and Pediatrics)

Nashville, Tennessee, United States, 37232

Actively Recruiting

37

Baylor Scott and White Research Institute (Adults only)

Dallas, Texas, United States, 75246

Actively Recruiting

38

University of Texas Southwestern Medical Center - Children's Medical Center (Pediatrics only)

Dallas, Texas, United States, 75390

Actively Recruiting

39

MD Anderson Cancer Center (Pediatrics and Adult)

Houston, Texas, United States, 77030

Actively Recruiting

40

Froedtert and Medical College of Wisconsin - Clinical Cancer Center (Adults only)

Milwaukee, Wisconsin, United States, 53226

Completed

41

The Children's Hospital at Westmead (Pediatrics only)

Westmead, New South Wales, Australia, 2145

Actively Recruiting

42

Westmead Hospital (Adults only)

Westmead, New South Wales, Australia, 2145

Actively Recruiting

43

The Prince Charles Hospital (Adults only)

Chermside, Queensland, Australia, 4032

Completed

44

Royal Adelaide Hospital (Adults only)

Adelaide, South Australia, Australia, 5000

Actively Recruiting

45

The Royal Children's Hospital Melbourne (Pediatrics only)

Melbourne, Victoria, Australia, 3052

Actively Recruiting

46

Fiona Stanley Hospital (Adults only)

Murdoch, Western Australia, Australia, 6150

Actively Recruiting

47

Medizinische Universitat Wien (Adults only)

Vienna, Austria, Austria, 1090

Active, Not Recruiting

48

Centre Hospitalier Universitaire de Liège Site Sart Tilman (Adults and Pediatrics)

Liège, Brussels Capital, Belgium, 4000

Completed

49

Universitair Ziekenhuis Leuven (Adults and Pediatrics)

Leuven, Flemish Brabant, Belgium, 3000

Active, Not Recruiting

50

Alberta Children's Hospital (Adults and Pediatrics)

Calgary, Alberta, Canada, T3B 6A8

Actively Recruiting

51

Sick Kids (Pediatrics only)

Toronto, Ontario, Canada, M5G 1X8

Actively Recruiting

52

Princess Margaret Cancer Centre (Adults only)

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

53

Centre Hospitalier Universitaire de Bordeaux (Adults only)

Pessac, Aquitaine, France, 33600

Completed

54

Centre Hospitalier Régional Universitaire de Lille (Adults and Pediatrics)

Lille, Hauts-de-France, France, 59037

Completed

55

Hôpital Necker-Enfants Malades (Pediatrics only)

Paris, Île-de-France Region, France, 75015

Completed

56

Hôpital Saint Antoine (Adults only)

Paris, Île-de-France Region, France, 75571

Completed

57

Hôpital Universitaire Pitié Salpêtrière (Adults only)

Paris, Île-de-France Region, France, 75651

Completed

58

Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda (Adults only)

Milan, Milano, Italy, 20162

Completed

59

Fondazione IRCCS Policlinico San Matteo (Adults and Pediatrics)

Pavia, Pavia, Italy, 27100

Completed

60

Fondazione Policlinico Universitario Agostino Gemelli (Adults only)

Roma, Roma, Italy, 00168

Completed

61

Ospedale Pediatrico Bambino Gesu (Pediatrics only)

Roma, Roma, Italy, 165

Completed

62

Azienda Ospedaliera - Universitaria Città della Salute e della Scienza di Torino (Adults only)

Torino, Torino, Italy, 10126

Completed

63

Hospital Duran i Reynals (Adults and Pediatrics)

Badalona, BARCELONA, Spain, 8908

Actively Recruiting

64

Hospital Universitari Vall d'Hebrón - Institut de Recerca (Adults and Pediatrics)

Barcelona, Barcelona, Spain, 08035

Actively Recruiting

65

Hospital Universitario Marqués de Valdecilla (Adults and Pediatrics)

Santander, Cantabria, Spain, 39008

Actively Recruiting

66

Hospital General Universitario Gregorio Marañón (Adults and Pediatrics)

Madrid, Madrid, Spain, 28009

Actively Recruiting

67

University Hospital Virgen del Rocio (Adults and Pediatrics)

Seville, Spain, Spain, 41013

Actively Recruiting

68

Hospital Universitario La Fe (Adults and Pediatrics)

Valencia, Valencia, Spain, 46009

Actively Recruiting

69

University Hospitals Birmingham NHS Foundation Trust (Adults only)

Birmingham, England, United Kingdom, B15 2GW

Actively Recruiting

70

King's College Hospital NHS Foundation Trust (Adults only)

London, England, United Kingdom, SE5 9RS

Completed

71

Imperial College Healthcare NHS Trust (Adults only)

London, England, United Kingdom, W12 0HS

Actively Recruiting

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Research Team

A

Anke Friedetzky

M

Marie Bosredon

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

Tabelecleucel for allogeneic haematopoietic stem-cell or solid organ transplant recipients with Epstein-Barr virus-positive post-transplant lymphoproliferative disease after failure of rituximab or rituximab and chemotherapy (ALLELE): a phase 3, multicentre, open-label trial.

Kris Michael Mahadeo, Robert Baiocchi, Amer Beitinjaneh...

https://pubmed.ncbi.nlm.nih.gov/38309282