Acalabrutinib for Diffuse large B-cell lymphoma | Non-Germinal Center (non-GCB) diffuse large B-cell lymphoma

Inclusion criteria

• {"criterion_text":"- Men and women, age ≥18 and ≤75 years"}
• {"criterion_text":"- Pathologically confirmed DLBCL, sufficient diagnostic material should be available to forward to a central laboratory for gene expression profiling and pathology review."}
• {"criterion_text":"- No prior treatment for DLBCL"}
• {"criterion_text":"- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2."}
• {"criterion_text":"- International Prognostic Index (IPI) score of 1 to 5"}
• {"criterion_text":"- Disease Stage II to IV by the Ann Arbor Classification"}
• {"criterion_text":"- Adequate organ and marrow function"}
• {"criterion_text":"- Agreement to use highly effective forms of contraception during the study and 12 months after the last dose of rituximab"}

Exclusion criteria

• {"criterion_text":"- Evidence of severe or uncontrolled systemic diseases"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Uncontrolled active systemic fungal, bacterial, viral, or other infection"}
• {"criterion_text":"- Prior anthracycline use ≥150 mg/m2"}
• {"criterion_text":"- Known history of a bleeding diathesis (i.e., haemophilia, von Willebrand disease)"}
• {"criterion_text":"- History of stroke or intracranial hemorrhage in preceding 6 months."}
• {"criterion_text":"- Known CNS lymphoma or leptomeningeal disease"}
• {"criterion_text":"- Known primary mediastinal lymphoma"}
• {"criterion_text":"- Known High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements"}
• {"criterion_text":"- Prior history of indolent lymphoma or CLL"}
• {"criterion_text":"- History of or ongoing confirmed PML"}
• {"criterion_text":"- 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"}

Primary endpoints

• {"endpoint_text":"- Progression-free survival (PFS) per the Lugano Classification for NHL in Arm A compared to Arm B","definition_or_measurement_approach":"Per the Lugano Classification for non-Hodgkin lymphoma; primary objective and endpoint measured as PFS based on investigator-assessed response."}

Secondary endpoints

• {"endpoint_text":"- Investigator-assessed event-free survival (EFS) for NHL in Arm A compared to Arm B","definition_or_measurement_approach":"Investigator-assessed event-free survival (EFS) comparison between arms."}
• {"endpoint_text":"- Percentage of Participants Who Achieved a Complete Response (CR) per 2014 Lugano Classification for NHL","definition_or_measurement_approach":"Proportion of participants achieving complete response (CR) according to 2014 Lugano Classification for NHL; assessed at end of treatment (per protocol/BICR for some assessments as indicated in objectives)."}
• {"endpoint_text":"- Overall survival in Arm A compared to Arm B","definition_or_measurement_approach":"Overall survival (OS) comparison between arms."}

Primary sponsor

Full Name

Acerta Pharma B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands

Contract research organisations

Name

Fortrea Inc.

Responsibilities

Multiple operational responsibilities as per sponsor duties codes listed (e.g. study operations, submissions, safety, data management)

Third parties

• {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"Sponsor duties code 3 (role code provided in Part I third parties)","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties code 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Medical image analysis/ review","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"RWS Life Sciences Inc.","duties_or_roles":"Translation of PROs, patient guide, license procurement","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePRO build, provision of devices, helpdesk support, eCOA query support","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veracyte Inc.","duties_or_roles":"Provisioning of LympMark Assay kits and training of central lab team to perform the test","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Center For Information And Study On Clinical Research Participation Inc.","duties_or_roles":"Patient material translations","organisation_type":"Patient organisation/association"}
• {"country":"India","full_name":"Tata Consultancy Services Limited","duties_or_roles":"Data Entry of Case safety reports","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"Central Laboratory, sample management for GEP testing, PK, biomarkers, NGS-MRD, pharmacodynamics","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Multiple sponsor duties (codes 1,2,6,7,9,10,11,12 etc.) as listed in Part I","organisation_type":"Pharmaceutical company"}