Acalabrutinib in Combination With R-miniCHOP in Older Adults With Untreated Diffuse Large B-Cell Lymphoma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age61+
SponsorUniversität des Saarlandes
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
R-miniCHOP + Acalabrutinib
Drug* Rituximab i.v.: 375 mg/m2 (D0) * Cyclophosphamide i.v.: 400 mg/m² (D1) * Doxorubicin i.v.: 25 mg/m² (D1) * Vincristine i.v.: 1 mg (D1) * Prednisolone p.o.: 40 mg/m² (D1 to D5) * Acalabrutinib 100 mg p.o. twice daily starting from D1 of first R-miniCHOP cycle continuously to D21 of cycle 8. Cycles repeated every 3 weeks
R-miniCHOP
Drug* Rituximab i.v.: 375 mg/m2 (D0) * Cyclophosphamide i.v.: 400 mg/m² (D1) * Doxorubicin i.v.: 25 mg/m² (D1) * Vincristine i.v.: 1 mg (D1) * Prednisolone p.o.: 40 mg/m² (D1 to D5). Cycles repeated every 3 weeks
Treatment groups
330 Participants
are divided into 2 treatment groupsGroup A: Standard armActive comparator 1 intervention
Group B: Experimental armExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Progression-free survival (PFS) investigator assessed
PFS, defined by the time between the day of randomization until one of the following events occurs, whichever comes first: Disease progression (PD), relapse after complete remission (CR) or death due to any cause, as per Lugano Classification of 2014. Patients who have not experienced an event at the time of analysis will be censored at the most recent date of disease assessment.
Time frame
Up to 5 yearsSecondary outcomes
1
Overall survival (OS)
OS, defined by the time between the day of randomization until death due to any cause. Patients who have not experienced an event at the time of analysis will be censored at the date when the patient was last known to be alive.
Time frame
Up to 5 years2
PFS based on blinded independent central review (BICR)
Time frame
Up to 5 years3
Event-free survival (EFS)
EFS, defined by the time between the day of randomization until one of the following events occurs, whichever comes first: Progressive disease (PD), relapse after complete remission (CR), initiation of subsequent systemic anti-lymphoma treatment and/or irradiation or death due to any cause, as per Lugano Classification of 2014.
Time frame
Up to 5 years4
PFS according to Cell of Origin as per immunohistochemistry
Time frame
Up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
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
Source ClinicalTrials.gov