Clinical trial NCT06601504: Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
Official title: A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma(R/R DLBCL)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Keywords: R-GemOx
R/R DLBCL
HMPL-760
Lead sponsor: Hutchmed
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Sign the Informed consent form(ICF) and be able to follow the requirements of study protocol;
2. Age ≥18 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status between 0 and 2;
4. Histopathologically confirmed diagnosis of DLBCL;
5. The investigator judges that the patient's current condition requires further treatment;
6. Patients should have at least one bi-dimensionally measurable lesion;
7. Expected survival is more than 12 weeks;

Exclusion Criteria:

1. Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
2. Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
3. Organ insufficiency;
4. Currently known history of liver disease, including cirrhosis, alcoholic liver, known active infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV):
5. History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
6. Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
7. Toxicities from prior anticancer therapy not resolved to Grade ≤ 1 (except for alopecia and decreased appetite);
8. Clinically significant active infection;

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Up to approximately 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: Up to approximately 2 years
measure: Complete response (CR) rate
timeFrame: Up to approximately 2 years
measure: Duration of response (DoR)
timeFrame: Up to approximately 2 years
measure: Clinical benefit rate (CBR)
timeFrame: Up to approximately 2 years
measure: Time to response (TTR)
timeFrame: Up to approximately 2 years
measure: Overall survival (OS)
timeFrame: Up to approximately 2 years
measure: Safety Endpoints of adverse events
timeFrame: Up to approximately 2 years
measure: Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
timeFrame: At the end of Cycle 7 (each cycle is 21 days)
measure: Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
timeFrame: At the end of Cycle 7 (each cycle is 21 days)
measure: Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
timeFrame: At the end of Cycle 7 (each cycle is 21 days)
measure: Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
timeFrame: At the end of Cycle 7 (each cycle is 21 days)
measure: Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
timeFrame: At the end of Cycle 7 (each cycle is 21 days)
measure: Pharmacokinetic(PK) profile of HMPL-760 in combination with R-GemOx
timeFrame: At the end of Cycle 7 (each cycle is 21 days)
Other outcomes:
measure: Biomarker assessment
timeFrame: Up to approximately 2 years
measure: Metabolite analysis of HMPL-760 in combination with R-GemOx
timeFrame: At the end of Cycle 7 (each cycle is 21 days)
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Nanning
country: China
facility: Guangxi Medical University Cancer Hospital
state: Guangxi
city: Wuhan
country: China
facility: Wuhan Union Hospital of China
state: Hebei
city: Harbin
country: China
facility: Harbin First Hospital
state: Heilongjiang
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Changsha
country: China
facility: Hunan Cancer Hospital
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital
state: Jiangxi
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
state: Liaoning
city: Jinan
country: China
facility: Shandong Cancer Hospital & Institute
state: Shandong
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
state: Tianjin
Study officials:
affiliation: Ruijin Hospital
name: Weili Zhao
role: PRINCIPAL_INVESTIGATOR
References: