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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
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.
Study details:
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-R and SOT-R+C (Cohort \[C\]-SOT) or HCT after failure of rituximab (C-HCT). SOT-R further included participants:. 1.
who did not receive chemotherapy and did not have a documented medical reason not to receive chemotherapy (SOT-Ro) or. 2. who were considered chemotherapy ineligible/inappropriate (SOT-R-Ci).
Combined population (SOT-R-Ci, SOT-R+C, and HCT) and (SOT-R-Ci and SOT-R+C) who received commercial product, or a product manufactured using a comparable process version (PV) were also used for analysis of outcomes. 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 (C-SOT) or up to 4 different HLA restrictions (C-HCT).
The study includes a total of 5 years of follow-up for disease and survival status.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 0 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2017-12-29
Primary completion: 2025-08-01
Study completion finish: 2027-06-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT03394365
Intervention or treatment
BIOLOGICAL: tabelecleucel
Conditions
- • Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- • Solid Organ Transplant Complications
- • Lymphoproliferative Disorders
- • Allogeneic Hematopoietic Cell Transplant
- • Stem Cell Transplant Complications
Find a site
Closest Location:
The Children's Hospital at Westmead (Pediatrics only)
Research sites nearby
Select from list below to view details:
The Children's Hospital at Westmead (Pediatrics only)
Westmead, New South Wales, Australia
Westmead Hospital (Adults only)
Westmead, New South Wales, Australia
The Prince Charles Hospital (Adults only)
Chermside, Queensland, Australia
Royal Adelaide Hospital (Adults only)
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Cohort SOT-R (C-SOT-R)
| BIOLOGICAL: tabelecleucel
|
EXPERIMENTAL: Cohort SOT-R+C (C-SOT-R+C)
| BIOLOGICAL: tabelecleucel
|
EXPERIMENTAL: Cohort HCT (C-HCT)
| BIOLOGICAL: tabelecleucel
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
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 | Not Specified | 2 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Duration of response (DOR) in the Analysis Cohorts C-SOT and C-HCT Separately | Not Specified | 2 years |
ORR and DOR in the Analysis Cohorts C-SOT and C-HCT Combined | Not Specified | 2 years |
ORR and DOR in Participants who Received Commercial Product or a Product Manufactured Using a Comparable PV in the Analysis Cohorts C-SOT-R-Ci and C-SOT-R+C Separately and Combined, and in the Analysis Cohort C-HCT | Not Specified | 2 years |
DOR in the Analysis Cohort of the 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 | Not Specified | 2 years |
Rates of Complete Response (CR) and Partial Response (PR) | Not Specified | 2 years |
Time to Response | Not Specified | 2 years |
Time to Best Response | Not Specified | 2 years |
Overall Survival (OS) | Not Specified | 2 years |
Rates of Allograft Loss or Rejection Episodes (Analysis Cohort C-SOT) | Not Specified | 2 years |
Frequently Asked Questions
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