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

Официальное название

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 Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Обзор

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.

Подробное описание

The study phases include screening period, treatment period, safety observation period, PFS follow-up period, and OS follow-up period.

The target population of this study includes patients with DLBCL who are relapsed or refractory.

Вмешательства

• Препарат HMPL-760
  Patients will receive HMPL-760 once daily (QD) orally.
• Препарат HMPL-760 Placebo
  Patients will receive HMPL-760 placebo once daily (QD) orally.
• Препарат R-GemOx
  R-GemOx regimen in 21-day cycles for a total of 8 cycles. Rituximab 375 mg/m2 IV is given on Day 1 of each cycle, and gemcitabine 1000 mg/m2 IV followed by oxaliplatin 100 mg/m2 IV is given on Day 2 of each cycle.

Первичные конечные точки

• Progression-free survival (PFS) [Срок оценки: Up to approximately two years]
• End of treatment (EOT) [Срок оценки: Up to approximately two years]
• Systemic antitumor therapy [Срок оценки: Up to approximately two years]
• Overall survival (OS) [Срок оценки: Up to approximately two years]
• systematic anti-tumor therapy [Срок оценки: Up to approximately two years]
• Premature withdrawal from study treatment [Срок оценки: Up to approximately two years]

Вторичные конечные точки (8)

• Independent review committee (IRC)-assessed PFS [Срок оценки: Up to approximately two years]
• IRC- and investigator-assessed objective response rate (ORR) [Срок оценки: Up to approximately two years]
• IRC- and investigator-assessed complete response rate (CRR) [Срок оценки: Up to approximately two years]
• IRC- and investigator-assessed duration of response (DoR) [Срок оценки: Up to approximately two years]
• IRC- and investigator-assessed clinical benefit rate (CBR) [Срок оценки: Up to approximately two years]
• IRC- and investigator-assessed time to response (TTR) [Срок оценки: Up to approximately two years]
• Safety Endpoints [Срок оценки: Up to approximately two years]
• PK characteristics of HMPL-760 in patients with R/R DLBCL when administered in combination with R-GemOx [Срок оценки: At the end of Cycle 4 (each cycle is 21 days)]]

Критерии участия

Критерии включения

• Sign the ICF and be able to follow the requirements of study protocol;
• Age ≥18 years;
• ECOG performance status score between 0 and 2;
• Histopathologically confirmed diagnosis of DLBCL;
• The investigator judges that the patient's current condition requires further treatment;
• Patients should have at least one bi-dimensionally measurable lesion;
• Expected survival is more than 12 weeks;

Критерии исключения

• Patients with known primary or secondary central nervous system lymphoma (CNSL) or the presence of clinical symptoms suggestive of CNSL;
• Women who are pregnant (positive pregnancy test during the screening period) or breastfeeding;
• Organ insufficiency;
• 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);
• History of significant organ bleeding, including gastrointestinal bleeding, hematencephalon, haemoptysis, etc., within 8 weeks prior to the first dose of study drug;
• Known risk of bleeding, such as coagulation factor deficiency, vascular hemophilia; or the patient is receiving vitamin K antagonist (warfarin);
• The toxic reactions of previous anti-tumor therapy have not recovered to the level of ≤ grade 1 (except for alopecia and decreased appetite and other conditions that have been clearly required in the inclusion and exclusion criteria);
• Clinically significant active infection;

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 50 центров

• Fudan University Shanghai Cancer Center — Шанхай
• Baoding NO.1 Central Hospital — Baoding
• Beijing GoBroad Hospital — Пекин
• BEIJING TONGREN HOSPITAL, Capital Medical University — Пекин
• The First Affiliated Hospital of Bengbu Medical College — Bengbu
• The First Hospital of Jilin University — Changchun
• Hunan Cancer Hospital — Чанша
• People's Hospital of Hunan Province — Чанша
• … и ещё 42 центра

Идентификаторы

NCT: NCT07409428 · 2025-760-00CH1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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