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 (ALLELE Study) - ALLELE study

Atara Biotherapeutics, Inc.0 个研究点目标入组 66 人开始时间: 2019年12月2日最近更新: 2021年4月5日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Atara Biotherapeutics, Inc.
入组人数: 66

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Prior SOT of kidney, liver, heart, lung, pancreas, small bowel, or any combination of these (SOT cohort);
•or prior allogeneic HCT (HCT cohort).
•2. A diagnosis of locally-assessed, biopsy-proven EBV+ PTLD.
•3. Availability of appropriate partially HLA-matched and restricted tabelecleucel has been confirmed by the sponsor.
•4. 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, head diagnostic CT
•and/or brain/spinal MRI as clinically appropriate will be required to follow CNS disease response per Lugano Classification response criteria.
•5. 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. Treatment failure is defined based on rituximab response as follows:
•a.Radiographic disease progression per Lugano Classification following a minimum cumulative dose
•of 1125 mg/m2 rituximab (typically, 3 weekly doses of 375 mg/m2), or
•b. Failure to achieve CR or PR, defined by Lugano radiographic criteria, after a minimum cumulative dose of 1500 mg/m2 rituximab (typically, 4 weekly doses of 375 mg/m2), or
•c. Relapse/progression of PTLD after a response to rituximab (SOT subgroup A or HCT cohort) or
•rituximab plus chemotherapy (SOT subgroup B), defined as radiographic and/or biopsy evidence of relapse/progression consistent with PTLD; if the underlying disease for which the subject underwent allogeneic HCT (HCT cohort) was lymphoma, biopsy confirmation of relapsed EBV+ PTLD is required.
•6. Males and females of any age.
•7. Eastern Cooperative Oncology Group performance status = 3 for subjects aged > 16 years; Lansky score = 20 for subjects from birth to 16 years.
•8. 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.
•9. Adequate organ function:
•a. Absolute neutrophil count = 1000/µL (SOT cohort) or = 500/µL (HCT cohort), with or without
•cytokine support
•b. 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)
•c. Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI)
•each < 5 × the upper limit of normal (ULN); however, ALT, AST, and TBILI each = 10 × ULN 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 (eg,
•elevated prothrombin time due to liver dysfunction, signs/symptoms of liver dysfunction such as
•asterixis, or similar).
•10. Subject or subject’s representative is willing and able to provide written informed consent.

排除标准

•1. Burkitt lymphoma, classical Hodgkin lymphoma, or any T-cell lymphoma.
•2. Daily steroids of > 0.5 mg/kg prednisone or glucocorticoid equivalent, ongoing methotrexate, or
•extracorporeal photopheresis.
•3. 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.
•4. Suspected or confirmed grade = 2 graft-versus-host disease per the Center for International Blood and Marrow Transplant Research (CIBMTR) consensus grading system at enrollment.
•5. 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.
•6. For HCT cohort only: Active adenovirus viremia.
•7. Need for vasopressor or ventilatory support.
•8. Antithymocyte globulin or similar anti-T-cell antibody therapy = 4 weeks prior to enrollment.
•9. Treatment with EBV-CTLs or chimeric antigen receptor (CAR) 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).
•10. 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.
•11. Inability to comply with study-related procedures

研究者

发起方

Atara Biotherapeutics, Inc.

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