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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