Leading Organizations Release Clinical Practice Guidelines for Transplantation and Cellular Therapies in MCL

The American Society of Transplantation and Cellular Therapy (ASTCT), Center of International Blood and Marrow Transplant Research (CIBMTR), and European Society for Blood and Marrow Transplantation (EBMT) released guidelines for autologous hematopoietic stem cell transplantation (autoHCT) allogeneic HCT (alloHCT), and chimeric antigen receptor T-cell (CAR-T) therapy for patients with newly diagnosed and relapsed/refractory mantle cell lymphoma (MCL; Transplant Cell Ther. 2021; 27[9]:720-728. doi:10.1016/j.jtct.2021.03.001). 

“There have been recent important advances in MCL therapy, including the demonstration of a survival benefit with rituximab maintenance following autoHCT, the advent of first- and second-generation BTK inhibitors for relapsed/refractory MCL, and the recent approval of the first commercially available CAR T-cell therapy for MCL,” wrote Pashna N. Munshi, MD, Department of Blood and Marrow Transplantation, MedStar Georgetown University Hospital, Washington, DC, and colleagues.

“Given these novel treatment options, guidance on the contemporary role, optimal timing, and sequencing of cellular therapies in MCL is warranted,” they continued.

ASTCT, CIBMTR, EBMT convened an expert panel to formulate recommendations for blood and bone marrow transplantation and CAR-T therapy for newly diagnosed and relapsed/refractory MCL. The panel comprised 33 physicians and investigators. 

The RAND-modified Delphi method was used to generate consensus statements addressing the role, timing, and sequencing of autoHCT, alloHCT, and CAR-T therapy in MCL, which were rated anonymously in at least 2 rounds of evaluations.

The first voting survey included 19 consensus statements. Consensus statements that met the predefined criteria formal consensus were recommended for approval. The statements that did not meet predefined criteria were discusses in a virtual meeting and either modified for revoting or dropped. The second voting survey included modified statements from the first survey or newly added statement.

Overall, the panel produced 17 consensus recommendations, including statements for transplantation and CAR-T therapy in the frontline setting for MCL with and without TP53 aberrations and statements for relapsed/refractory MCL. 

Key statements included:

• In the frontline setting, autoHCT consolidation is standard of care in eligible patients, though there is no clear role for alloHCT or CAR-T therapy outside of clinical trials.
• In the relapsed/refractory setting, the preferred option is CAR-T therapy, especially in patients failing or intolerant to ≥1 BTK inhibitor. However, alloHCT is recommended is CAR-T therapy fails or is not feasible.

The panel formulated consensus statements for important real-world clinical scenarios to guide clinical practice.

“In the absence of contemporary evidence-based data, the panel found RAND-modified Delphi methodology effective in providing a formal framework for developing consensus recommendations for the timing and sequence of cellular therapies for MCL,” concluded Dr Munshi and colleagues.