About this trial
The goal of this clinical trial is to study the addition of Acalabrutinib to standard R-miniCHOP in older adults with DLBCL. The main question it aims to answer is whether progression free survival kann be prolonged with the addition of Acalabrutinib.
Participants will be randomised to receive either R-miniCHOP alone or R-miniCHOP with Acalabrutinib.
Eligibility criteria
Qualifiers
Compliance with the requirements and restrictions listed in the informed consent form (ICF).
Authorization to use protected health information/data [in accordance with the General Data Protection Regulation (GDPR)].
Provision of signed and dated, written ICF prior to any mandatory study specific procedures, sampling, and analyses
Willing and able to participate in all required evaluations and procedures in this study protocol, including swallowing capsules and tablets without difficulty.
Disqualifiers
Evidence of disease (such as severe or uncontrolled systemic diseases, including uncontrolled hypertension and renal transplant) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol [e.g. a single score of 4 on one single category on the CIRS-G-Score (but not a cumulative score of 4)].
Significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of randomization or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or LVEF < 40%. Patients with controlled, asymptomatic atrial fibrillation are allowed to enroll on study.
Severe pulmonary dysfunction (CTCAE grade 3 or 4) unless associated with lymphoma.
Severe psychiatric or neurologic disease that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol.
Trial design
Treatments tested in this trial
- R-miniCHOP + Acalabrutinib
- R-miniCHOP
Treatment groups
Sponsors and collaborators
Universität des Saarlandes
Lead sponsor
University of Leipzig
Collaborator
University Hospital Regensburg
Collaborator
Wuerzburg University Hospital
Collaborator
University Hospital Giessen and Marburg
Collaborator
Saarland University Medical Center
Collaborator
AstraZeneca
Collaborator