Diffuse large B-cell lymphoma MedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Acerta Pharma B.V. (A Member of the AstraZeneca Group)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Men and women, age =18 and =75 years - Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review. - No prior treatment for DLBCL - Eastern Cooperative Oncology Group (ECOG) performance status of = 2. - International Prognostic Index (IPI) score of 1 to 5 - Disease Stage II to IV by the Ann Arbor Classification - Adequate organ and marrow function - Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 420 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 180
Exclusion criteria
Exclusion criteria: - Evidence of severe or uncontrolled systemic diseases - Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease) - History of stroke or intracranial haemorrhage in preceding 6 months. - Known CNS lymphoma or leptomeningeal disease - Known primary mediastinal lymphoma - Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements - Prior history of indolent lymphoma or CLL - History of or ongoing confirmed PML - Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification - Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass. - Uncontrolled active systemic fungal, bacterial, viral, or other infection - Prior anthracycline use =150 mg/m2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate if the addition of acalabrutinib to RCHOP prolongs PFS, as compared with placebo plus R-CHOP alone in subjects =75 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, based on investigator-assessed response.;Secondary Objective: - To evaluate EFS with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subject =75 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, as assessed by investigator - To evaluate CR rate with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects =75 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP, as assessed by BICR (Blinded Independent Central Review) - To evaluate overall survival (OS) with acalabrutinib plus R-CHOP compared with placebo plus R-CHOP in subjects =75 years with previously untreated non-GCB DLBCL (ABC or unclassified) selected by GEP;Primary end point(s): Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B;Timepoint(s) of evaluation of this end point: At every single visit up to 60 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B 2. Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification at the end of study treatment. 3. Overall survival in Arm A compared to Arm B;Timepoint(s) of evaluation of this end point: 1. EFS: at every single visit up to 60 months 2. CR: at every single visit up to 60 months 3. OS: at every single visit up to 60 months | — |
Countries
Australia, Austria, Belgium, Brazil, Canada, China, Czechia, Czech Republic, France, Germany, India, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United States
Contacts
Public ContactClinical Study Information Center
AstraZeneca
Outcome results
None listed