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

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

330 Participants
are divided into 2 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