Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
NCT ID: NCT06601504
Last Updated: 2025-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
61 participants
INTERVENTIONAL
2024-11-05
2026-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A: HMPL-760 planned dose 1 once daily (QD) in combination with R-GemOx regimen
Group A: Patients will receive HMPL-760 planned dose 1 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with 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 planned dose 1
HMPL-760 planned dose 1 daily (QD) orally
R-GemOx
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.
Group B: HMPL-760 placebo planned dose 1 once daily (QD) in combination with R-GemOx regimen
Patients will receive HMPL-760 placebo planned dose 1 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with 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.
R-GemOx
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
HMPL-760 placebo planned dose 1 daily (QD) orally
Group C: HMPL-760 planned dose 2 once daily (QD) in combination with R-GemOx regimen
Patients will receive HMPL-760 planned dose 2 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with 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.
R-GemOx
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 planned dose 2
HMPL-760 planned dose 2 daily (QD) orally
Group D: HMPL-760 placebo planned dose 2 once daily (QD) in combination with R-GemOx regimen
Patients will receive HMPL-760 placebo planned dose 2 once daily (QD) orally from Cycle 1 Day 1 until disease progression(PD), patient death, intolerable toxicity, etc., in combination with 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.
R-GemOx
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 2
HMPL-760 placebo planned dose 2 daily (QD) orally
Interventions
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HMPL-760 planned dose 1
HMPL-760 planned dose 1 daily (QD) orally
R-GemOx
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
HMPL-760 placebo planned dose 1 daily (QD) orally
HMPL-760 planned dose 2
HMPL-760 planned dose 2 daily (QD) orally
HMPL-760 placebo planned dose 2
HMPL-760 placebo planned dose 2 daily (QD) orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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;
18 Years
ALL
No
Sponsors
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Hutchmed
INDUSTRY
Responsible Party
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Principal Investigators
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Weili Zhao
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
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
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China
Shandong Cancer Hospital & Institute
Jinan, Shandong, China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, Tianjin Municipality, China
Countries
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Other Identifiers
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2024-760-00CH1
Identifier Type: -
Identifier Source: org_study_id
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