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Table 1 Key inclusion and exclusion criteria for the STELLAR randomised trial

From: The STELLAR trial protocol: a prospective multicentre trial for Richter’s syndrome consisting of a randomised trial investigation CHOP-R with or without acalabrutinib for newly diagnosed RS and a single-arm platform study for evaluation of novel agents in relapsed disease

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