Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL

HUTCHMED

Status and phase: Active, not recruiting; Phase 2

Conditions: Relapsed/Refractory Diffuse Large B-Cell Lymphoma

Treatments: Drug: HMPL-760 placebo planned dose 1; Drug: HMPL-760 planned dose 1; Drug: HMPL-760 placebo planned dose 2; Drug: R-GemOx; Drug: HMPL-760 planned dose 2

Study type: Interventional

Funder types: Industry

Identifiers

NCT06601504

2024-760-00CH1

Details and patient eligibility

About

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).

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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61 participants in 4 patient groups, including a placebo group

Group A: HMPL-760 planned dose 1 once daily (QD) in combination with R-GemOx regimen

Experimental group

Description:

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.

Treatment:

Drug: R-GemOx

Drug: HMPL-760 planned dose 1

Group B: HMPL-760 placebo planned dose 1 once daily (QD) in combination with R-GemOx regimen

Placebo Comparator group

Description:

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.

Treatment:

Drug: R-GemOx

Drug: HMPL-760 placebo planned dose 1

Group C: HMPL-760 planned dose 2 once daily (QD) in combination with R-GemOx regimen

Experimental group

Description:

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.

Treatment:

Drug: HMPL-760 planned dose 2

Drug: R-GemOx

Group D: HMPL-760 placebo planned dose 2 once daily (QD) in combination with R-GemOx regimen

Placebo Comparator group

Description:

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.

Treatment:

Drug: R-GemOx

Drug: HMPL-760 placebo planned dose 2