Status:
ACTIVE_NOT_RECRUITING
A Combination of Acalabrutinib With R-CHOP in Subjects With Previously Untreated Non-GCB DLBCL (ACE-LY-312)
Lead Sponsor:
Acerta Pharma BV
Collaborating Sponsors:
AstraZeneca
Conditions:
Diffuse Large B-Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Phase 3 randomized, double-blind, placebo-controlled, study assessing the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs pla...
Detailed Description
Phase 3 randomized, double-blind, placebo-controlled, study to evaluate the efficacy and safety of acalabrutinib plus rituximab,cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as c...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2027
Estimated Enrollment :
611 Patients enrolled
Trial Details
Trial ID
NCT04529772
Start Date
October 8 2020
End Date
February 1 2027
Last Update
December 24 2025
Active Locations (255)
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1
Research Site
Tucson, Arizona, United States, 85711
2
Research Site
Little Rock, Arkansas, United States, 72205
3
Research Site
Irvine, California, United States, 92618
4
Research Site
Aurora, Colorado, United States, 80012