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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Richter syndrome
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
2019 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/31109313 protocol (added 22/05/2019)
You can take part if:
You may not be able to take part if:
Exclusion criteria ALL:1. Known central nervous system (CNS) involvement of CLL or DLBCL2. Any other active malignancy that requires active treatment, with the exception of basal cell carcinoma, in-situ cervical cancer, and non-invasive squamous cell carcinoma of the skin3. Chronic or ongoing active infectious disease4. Positive serology for Hepatitis B (HBKnown human immunodeficiency virus (HIV) positive5. Patients with active bleeding or history of bleeding diathesis (e.g. haemophilia, von Willebrand disease)6. Patients receiving therapeutic anticoagulation with warfarin or equivalent (e.g. phenoprocoumon)7. Uncorrected prolonged prothrombin time (PT) or an activated partial thromboplastin time (APTT) > 2 x the upper limit of normal (ULN)8. Major surgery within 30 days prior to randomisation and/or inadequate recovery from any prior major surgery, toxicity or complications9. Patients with malabsorption syndrome or medical conditions significantly affecting gastrointestinal function10. Clinically significant cardiac disease including unstable angina, uncontrolled congestive heart failure, and unstable arrhythmias requiring therapy, with the exception of extra systoles or minor conduction abnormalities11. Significant concurrent, uncontrolled severe medical condition including, but not limited to, renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease12. History of significant cerebrovascular disease in the 6 months prior to randomisation, including intracranial haemorrhage13. Known or suspected hypersensitivity to components of the investigational products14. Patients who have received treatment with any non-marketed drug substance or experimental therapy within 4 weeks prior to proposed start of treatment 15. Current participation in any other interventional clinical study16. Patients known or suspected of not being able to comply with a study17. Breastfeeding women or women with a positive pregnancy test at screening18. Women of childbearing potential and men not willing to use adequate contraception during study and for 3 months after last dose of study therapy
Additional exclusion criteria for the Randomised Trial:1. Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation2. Ibrutinib-exposed CLL patients who have been newly diagnosed with RS within four weeks of their last dose of ibrutinib. (Ibrutinib-exposed CLL patients who discontinue ibrutinib due to toxicity or progressive CLL and later (more than four weeks) develop RS are not excluded from the randomised trial component)3. Previous acalabrutinib exposure
Additional exclusion criteria for Cohort 1 (progressive RS following chemo-immunotherapy):1. Previous acalabrutinib exposure
Additional exclusion criteria for Cohort 2 (anthracycline-naïve RS patients, diagnosed while on ibrutinib):1. Prior therapy with CHOP or any anthracycline containing treatment at any time prior to randomisation2. Previous acalabrutinib exposure
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.
Miss
Sophie
Cramp
+44 (0)1213717867
STELLAR@trials.bham.ac.uk
The study is sponsored by University of Birmingham and funded by Acerta Pharma; Bloodwise; Grant Codes: 17003.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
