The goal of this study is to evaluate the efficacy of HMPL-760 in combination with R-GemOx versus placebo in combination with R-GemOx in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL).
A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 in Combination with R-GemOx versus Placebo in Combination with R-GemOx in Patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (R/R DLBCL). The study phases include screening period, treatment period, safety observation period, PFS follow-up period, and OS follow-up period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
61
HMPL-760 planned dose 1 daily (QD) orally
R-GemOx regimen includes Rituximab Injection, Gemcitabine Hydrochloride for Injection, Gemcitabine Hydrochloride for Injection. R-GemOx regimen in 21-day cycle for a total of 6 cycles. Rituximab 375 mg/m\^2 ivgtt is given on day 1 of each cycle, and gemcitabine 1000 mg/m\^2 ivgtt is given, followed by oxaliplatin 100 mg/m\^2 ivgtt on day 2 of each cycle.
HMPL-760 placebo planned dose 1 daily (QD) orally
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
Progression-free survival (PFS)
Progression-free survival (PFS): Efficacy is evaluated using the Lugano Efficacy Evaluation Criteria for Malignant Lymphoma (Cheson 2014).
Time frame: Up to approximately 2 years
Objective Response Rate (ORR)
Objective Response Rate (ORR) is defined as the ratio of patients who reached complete response (CR) or partial response (PR), as assessed by investigator.
Time frame: Up to approximately 2 years
Complete response (CR) rate
Complete response (CR) rate is defined as the ratio of patients with who reached complete response (CR), as assessed by investigator.
Time frame: Up to approximately 2 years
Duration of response (DoR)
For patients who reached complete response (CR) or partial response (PR), Duration of Response (DoR) is defined as the time from the first CR or PR until disease progression or death due to any cause, whichever occurs first, as assessed by investigator.
Time frame: Up to approximately 2 years
Clinical benefit rate (CBR)
Defined as the ratio of patients with complete response (CR), partial response (PR), or stable disease (SD).
Time frame: Up to approximately 2 years
Time to response (TTR)
Time To Response (TTR) is defined as the time from the start of treatment to the first objective response rate (ORR), as assessed by investigator.
Time frame: Up to approximately 2 years
Overall survival (OS)
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HMPL-760 planned dose 2 daily (QD) orally
HMPL-760 placebo planned dose 2 daily (QD) orally
Guangxi Medical University Cancer Hospital
Nanning, Guangxi, China
Wuhan Union Hospital of China
Wuhan, Hebei, China
Harbin First Hospital
Harbin, Heilongjiang, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Henan Cancer Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Hunan Cancer Hospital
Changsha, Hunan, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China
...and 6 more locations
Overall Survival (OS) is defined as the time from randomization to death due to any cause.
Time frame: Up to approximately 2 years
Safety Endpoints of adverse events
Incidence and severity of treatment-emergent adverse events (TEAEs), incidence of serious adverse events (SAEs), incidence of TEAEs leading to permanent discontinuation, dose interruption, and dose reduction, and their correlation to study drug. The severity is determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).
Time frame: Up to approximately 2 years
Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
Trough plasma concentration (Ctrough) of drug
Time frame: At the end of Cycle 7 (each cycle is 21 days)
Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
Maximum observed concentration, occurring at time Tmax at steady-state (Cmax,ss) of drug
Time frame: At the end of Cycle 7 (each cycle is 21 days)
Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
Time of maximum observed concentration at steady-state(Tmax,ss) of drug
Time frame: At the end of Cycle 7 (each cycle is 21 days)
Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
The partial area from dosing time to dosing time plus Tau at steady-state (AUCss) of drug
Time frame: At the end of Cycle 7 (each cycle is 21 days)
Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
Apparent clearance at steady-state (CLss/F) of drug (if applicable)
Time frame: At the end of Cycle 7 (each cycle is 21 days)
Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
Apparent volume of distribution at steady-state (Vz,ss/F) of drug (if applicable)
Time frame: At the end of Cycle 7 (each cycle is 21 days)