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 |