A Phase III Study of HMPL-760 Plus R-GemOx VS Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HMPL-760, HMPL-760 Placebo, R-GemOx.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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)
Overview
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.
Detailed description
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.
Interventions
- Drug HMPL-760
Patients will receive HMPL-760 once daily (QD) orally. - Drug HMPL-760 Placebo
Patients will receive HMPL-760 placebo once daily (QD) orally. - Drug 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.
Primary outcome measures
- Progression-free survival (PFS) [Time frame: Up to approximately two years]
- End of treatment (EOT) [Time frame: Up to approximately two years]
- Systemic antitumor therapy [Time frame: Up to approximately two years]
- Overall survival (OS) [Time frame: Up to approximately two years]
- systematic anti-tumor therapy [Time frame: Up to approximately two years]
- Premature withdrawal from study treatment [Time frame: Up to approximately two years]
Secondary outcome measures (8)
- Independent review committee (IRC)-assessed PFS [Time frame: Up to approximately two years]
- IRC- and investigator-assessed objective response rate (ORR) [Time frame: Up to approximately two years]
- IRC- and investigator-assessed complete response rate (CRR) [Time frame: Up to approximately two years]
- IRC- and investigator-assessed duration of response (DoR) [Time frame: Up to approximately two years]
- IRC- and investigator-assessed clinical benefit rate (CBR) [Time frame: Up to approximately two years]
- IRC- and investigator-assessed time to response (TTR) [Time frame: Up to approximately two years]
- Safety Endpoints [Time frame: Up to approximately two years]
- PK characteristics of HMPL-760 in patients with R/R DLBCL when administered in combination with R-GemOx [Time frame: At the end of Cycle 4 (each cycle is 21 days)]]
Eligibility criteria
Inclusion criteria
- 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;
Exclusion criteria
- 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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 50 centers
- Fudan University Shanghai Cancer Center — Shanghai
- Baoding NO.1 Central Hospital — Baoding
- Beijing GoBroad Hospital — Beijing
- BEIJING TONGREN HOSPITAL, Capital Medical University — Beijing
- The First Affiliated Hospital of Bengbu Medical College — Bengbu
- The First Hospital of Jilin University — Changchun
- Hunan Cancer Hospital — Changsha
- People's Hospital of Hunan Province — Changsha
- … and 42 more centers
Identifiers
NCT: NCT07409428 · 2025-760-00CH1