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A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

RecruitingPhase 3Ages 18 Years - anyAllHutchmed
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In plain words

What the trial is, and whether it could suit you

This is a Phase III randomized, double-blind, positive 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 R/R DLBCL.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Sign the ICF and be able to follow the requirements of study protocol; 2. Age โ‰ฅ18 years; 3. ECOG performance status score 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. The toxic reactions of previous anti-tumor therapy have not recovered to the level of โ‰ค grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria); 8. Clinically significant active infection;
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What it tests

  • HMPL-760
  • HMPL-760 Placebo
  • R-GemOx
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Where

50 sites
Fudan University Shanghai Cancer Center
Shanghai, China
Baoding NO.1 Central Hospital
Baoding, China
Beijing GoBroad Hospital
Beijing, China
BEIJING TONGREN HOSPITAL, Capital Medical University
Beijing, China
The First Affiliated Hospital of Bengbu Medical College
Bengbu, China
The First Hospital of Jilin University
Changchun, China
Hunan Cancer Hospital
Changsha, China
People's Hospital of Hunan Province
Changsha, China

โ€ฆand 42 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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