This study will treat patients with diffuse large B-cell lymphoma (DLBCL). It will assess the anti-tumor efficacy and safety of DZD8586 combination therapy by using objective response rate and the incidence and severity of adverse events. It will also measure the levels of DZD8586 in the body when combined with immunochemotherapy regimens.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
150
DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-CHOP (Rituximab: 375 mg/m2, IV, d1; Cyclophosphamide: 750 mg/m2, IV, d1; Doxorubicin: 50 mg/m2, IV, d1; Vincristine: 1.4 mg/m2, IV, d1; Prednisone: 100 mg, po, d1-5) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.
DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with R-GemOx (Rituximab: 375 mg/m2, IV, d1; Gemcitabine: 1000 mg/m2, IV, d1; Oxaliplatin: 100 mg/m2, IV, d1) in a 21-day cycle for 8 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.
DZD8586 at the protocol defined dose level (50 mg or 75 mg, po, qd) with BR (Bendamustine: 90 mg/m2, IV, d1-d2; Rituximab: 375 mg/m2, IV, d1) in a 21-day cycle for 6 cycles. DZD8586 (pre-defined dose level, po, qd) as maintenance therapy for CR/PR patients.
Peking University Third Hospital
Beijing, China
RECRUITINGHunan Cancer Hospital
Changsha, China
NOT_YET_RECRUITINGPart A: Incidence and severity of adverse events
Time frame: Approximately 5 years
Part B: Objective response rate (ORR)
Time frame: Approximately 5 years
Part A: Objective response rate (ORR)
Time frame: Approximately 5 years
Part A: Complete response rate (CRR)
Time frame: Approximately 5 years
Part A: Time to response (TTR)
Time frame: Approximately 5 years
Part A: Duration of Response (DoR)
Time frame: Approximately 5 years
Part A: Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Part A: Overall Survival (OS)
Time frame: Approximately 5 years
Part B: Incidence and severity of adverse events
Time frame: Approximately 5 years
Part B: Complete response rate (CRR)
Time frame: Approximately 5 years
Part B: Time to response (TTR)
Time frame: Approximately 5 years
Part B: Duration of Response (DoR)
Time frame: Approximately 5 years
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West China Hospital of Sichuan University
Chengdu, China
RECRUITINGGuangdong Provincial People's Hospital
Guangzhou, China
RECRUITINGSun Yat-sen University Cancer Center
Guangzhou, China
RECRUITINGZhujiang Hospital of Southern Medical University
Guangzhou, China
RECRUITINGThe Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, China
RECRUITINGAnhui Provincial Cancer Hospital
Hefei, China
RECRUITINGLinyi Cancer Hospital
Linyi, China
RECRUITINGShanxi Cancer Hospital
Taiyuan, China
RECRUITING...and 3 more locations
Part B: Progression-Free Survival (PFS)
Time frame: Approximately 5 years
Part B: Overall Survival (OS)
Time frame: Approximately 5 years
Part A: Peak plasma concentration (Cmax) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Area under the plasma concentration versus time curve (AUC) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Time to peak concentration (Tmax) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Metabolite (DZ4581) to parent (DZD8586) ratio based on area under the plasma concentration versus time curve (MRAUC)
Time frame: Up to 24 hours post dose
Part A: Trough concentration at steady state (Css, min) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Apparent clearance at steady state (CLss/F) of DZD8586
Time frame: Up to 24 hours post dose
Part A: Accumulation index in area under the plasma concentration versus time curve (RACAUC) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose
Part A: Accumulation index in peak plasma concentration (RACCmax) of DZD8586 and metabolite (DZ4581)
Time frame: Up to 24 hours post dose