This study will treat patients with newly diagnosed diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of birelentinib plus rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) vs placebo plus R-CHOP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
880
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hunan Cancer Hospital
Changsha, Hunan, China
Cancer Hospital of Shandong Frist Medical University
Jinan, Shangdong, China
Part A: Incidence and severity of adverse events
Time frame: Up to 2 years
Part B: Progression-free survival (PFS)
Time frame: Up to 5 years
Part A: Objective response rate (ORR)
Time frame: Up to 5 years
Part A: Complete response rate (CRR)
Time frame: Up to 5 years
Part B: Event-free survival (EFS)
Time frame: Up to 5 years
Part B: Overall Survival (OS)
Time frame: Approximately 5 years
Part B: Objective response rate (ORR)
Time frame: Up to 5 years
Part B: Complete response rate (CRR)
Time frame: Up to 5 years
Part B: Incidence and severity of adverse events
Time frame: Up to 2 years
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Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, China