Lymphomas are blood cancers that develop in the lymphatic system and are divided into Hodgkin lymphoma and non-Hodgkin lymphomas (NHL). NHLs are categorized as B-cell, Tcell, or natural killer/T-cell lymphoma, depending on the cell implicated in the disease. While B-cell NHLs display a wide range of clinical behaviours, there are several subtypes that have a roughly similar clinical course and are treated in a similar manner. These subtypes include diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. In Canada, NHL accounts for 83% of all cases of lymphomas.

In this context, axicabtagene ciloleucel is a chimeric antigen receptor (CAR) T-cell therapy that has been approved by the FDA for use in “adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.” As Health Canada approval for axicabtagene ciloleucel is pending, the final indication remains to be confirmed; however, based on the available evidence and existing approvals for this therapy (i.e., by the FDA and the European Union), potentially eligible indications are these types of relapsed or refractory large B-cell lymphomas: DLBCL, primary mediastinal B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma.

Contents

• Abbreviations
• Protocol Amendments
• Background and Rationale
  • Clinical Need and Target Population
  • A Brief Overview of CAR T-Cell Therapy and Axicabtagene Ciloleucel
  • Rationale for the Health Technology Assessment
• Policy Question
• Objectives
• Research Questions for Clinical Review
• Clinical Review Methods
  • Literature Search Methods
  • Study Design
  • Study Eligibility Criteria
  • Literature Screening and Study Selection
  • Data Extraction
• Critical Appraisal of Studies
• Data Analysis
• References
• Appendix 1. Literature Search Strategy
• Appendix 2. Therapy Procedure Overview
• Appendix 3. Review Framework
• Appendix 4. Checklists for Screening References

Suggested citation:

Axicabtagene Ciloleucel for Large B-cell Lymphoma: Health Technology Assessment Introduction and Clinical Review Protocol. Ottawa: CADTH; 2019 May. (CADTH optimal use report; vol. 9, no.1a).

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