Table 1.

Key inclusion and exclusion criteria for the STELLAR randomised trial

Study cohort	Diagnosis	Prior treatment	Inclusion	Exclusion (all cohorts)
Randomised STELLAR trial CHOP-R plus acalabrutinib versus CHOP-R	Newly diagnosed DLCBL-type RS	No prior RS treatment1 No prior anthracycline. No prior acalabrutinib exposure No prior ibrutinib or ibrutinib discontinued > 4 weeks ago due to toxicity.	ECOG Performance Score 0–3 Suitable for anthracycline containing chemo-immunotherapy Age ≥ 16 years Signed informed consent	Known CNS involvement by CLL or RS Any other malignancy requiring active treatment Chronic or ongoing active infectious disease Positive Hep B serology HIV positive Bleeding disorder. Requirement for warfarin anticoagulation Stroke or intracranial bleed in the 6 months prior to randomisation Significant concurrent, uncontrolled severe medical condition including cardiac, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease Inability to comply with study protocol Pregnancy and breastfeeding. disease
Platform Cohort 1 Progressive RS following chemoimmunotherapy Acalabrutinib monotherapy	R/R DLCBL-type RS	Previous anthracycline based chemotherapy plus anti-CD20 monoclonal antibody	ECOG Performance Score 0–3 Age ≥ 16 years Signed informed consent
Platform Cohort 2 CHOP-R plus acalabrutinib	Newly diagnosed DLBCL-type RS	Ibrutinib within 4 weeks of diagnosis. No prior anthracycline.	ECOG Performance Score 0–3 Suitable for anthracycline containing chemo-immunotherapy Age ≥ 16 years Signed informed consent

¹Pre-treatment with prednisolone up to 2 mg/kg is allowed for up to 14 days prior to the start of treatment