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Summary  Multiple oncogenic events are involved in the development of adult T‐cell leukaemia/lymphoma (ATL). Because CD28 plays a pivotal role in T‐cell activation, we focused on alterations of the  CD28  gene in ATL. We found multiple genetic abnormalities related to  CD28  among the 144 patients enrolled in the present study. These involved gene fusions with the  cytotoxic T‐lymphocyte‐associated antigen 4  or the  inducible T‐cell co‐stimulator  in 14 patients (10%),  CD28 ‐activating mutations in 3 (2%), and  CD28  copy number variations in 34 (24%). Patients with such  CD28  gene alterations were significantly younger than those without. In patients not receiving allogeneic haematopoietic stem cell transplantation, those with  CD28  gene alterations tended to have a worse prognosis than those without. Finally, patients with chronic or smouldering ATL subtypes with  CD28  gene alterations had a significantly worse prognosis than those without. These findings indicate that ATL, especially chronic or smouldering subtypes, have a more aggressive clinical course and are more refractory to conventional chemotherapies or mogamulizumab if they harbour  CD28  gene alterations, likely because of continuous, prolonged, and enhanced CD28 activatory signalling. Novel treatment strategies to overcome the effects of these  CD28  gene alterations are warranted.

Clinical significance of CD28 gene‐related activating alterations in adult T‐cell leukaemia/lymphoma