Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab (MATCH)
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|ClinicalTrials.gov Identifier: NCT03392142|
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : December 23, 2019
|Condition or disease||Intervention/treatment||Phase|
|Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) Stem Cell Transplant Complications Lymphoproliferative Disorders||Biological: tabelecleucel||Phase 3|
Expanded Access : An investigational treatment associated with this study is available outside the clinical trial. More info ...
This is a multicenter, open label, single-arm, phase 3 study to assess the efficacy and safety of tabelecleucel for the treatment of EBV+ PTLD in the setting of allogeneic HCT after failure of rituximab.
Tabelecleucel will be selected for the subject from the bank of available tabelecleucel cell products based on matching >= 2 human leukocyte antigen (HLA) alleles, at least one of which is a restricting HLA allele, shared between the tabelecleucel donor and the subject's EBV+ PTLD. Sites will provide high resolution subject and subject's graft donor HLA typing results and other information as required by the protocol.
Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) tabelecleucel at a dose of 2×10^6 cells/kg on Days 1, 8, and 15, followed by observation through Day 35.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||33 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Multicenter, Open-Label, Phase 3 Study of Tabelecleucel for Allogeneic Hematopoietic Cell Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure of Rituximab|
|Actual Study Start Date :||December 29, 2017|
|Estimated Primary Completion Date :||November 2020|
|Estimated Study Completion Date :||November 2020|
Tabelecleucel will be administered in cycles lasting 5 weeks (35 days). During each cycle, subjects will receive intravenous (IV) tabelecleucel at a dose of 2 x 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 multiple tabelecleucel cell products.
Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
- Objective response rate (ORR) [ Time Frame: 2 years ]
- Overall survival (OS) [ Time Frame: 5 years ]
- Duration of response (DOR) [ Time Frame: 2 years ]
- PTLD progression-free survival (PFS) following best response [ Time Frame: 2 years ]
- Rate of durable response [ Time Frame: 2 years ]
- Time to progression [ Time Frame: 2 years ]
- Patient reported outcome: EQ-5D [ Time Frame: 2 years ]
- Patient reported outcome: Functional Assessment of Cancer Therapy Lymphoma (FACT-Lym) [ Time Frame: 2 years ]
- Incidence of related and unrelated adverse events (AE), including AEs of special interest [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03392142
|Contact: Minoti Hiremath, MBBS, PhDemail@example.com|
|Study Director:||Minoti Hiremath, MBBS, PhD||Atara Biotherapeutics|