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Trial Title:
Study of HMPL-760 Puls R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
NCT ID:
NCT06601504
Condition:
Relapsed/Refractory Diffuse Large B-Cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Gemcitabine
Conditions: Keywords:
R-GemOx
R/R DLBCL
HMPL-760
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
HMPL-760 planned dose 1
Description:
HMPL-760 planned dose 1 daily (QD) orally
Arm group label:
Group A: HMPL-760 planned dose 1 once daily (QD) in combination with R-GemOx regimen
Intervention type:
Drug
Intervention name:
R-GemOx
Description:
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.
Arm group label:
Group A: HMPL-760 planned dose 1 once daily (QD) in combination with R-GemOx regimen
Arm group label:
Group B: HMPL-760 placebo planned dose 1 once daily (QD) in combination with R-GemOx regimen
Arm group label:
Group C: HMPL-760 planned dose 2 once daily (QD) in combination with R-GemOx regimen
Arm group label:
Group D: HMPL-760 placebo planned dose 2 once daily (QD) in combination with R-GemOx regimen
Other name:
Rituximab Injection, Gemcitabine Hydrochloride for Injection, Gemcitabine Hydrochloride for Injection
Intervention type:
Drug
Intervention name:
HMPL-760 placebo planned dose 1
Description:
HMPL-760 placebo planned dose 1 daily (QD) orally
Arm group label:
Group B: HMPL-760 placebo planned dose 1 once daily (QD) in combination with R-GemOx regimen
Intervention type:
Drug
Intervention name:
HMPL-760 planned dose 2
Description:
HMPL-760 planned dose 2 daily (QD) orally
Arm group label:
Group C: HMPL-760 planned dose 2 once daily (QD) in combination with R-GemOx regimen
Intervention type:
Drug
Intervention name:
HMPL-760 placebo planned dose 2
Description:
HMPL-760 placebo planned dose 2 daily (QD) orally
Arm group label:
Group D: HMPL-760 placebo planned dose 2 once daily (QD) in combination with R-GemOx regimen
Summary:
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).
Detailed 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.
Criteria for eligibility:
Criteria:
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;
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Country:
China
Start date:
October 29, 2024
Completion date:
November 12, 2026
Lead sponsor:
Agency:
Hutchmed
Agency class:
Industry
Source:
Hutchmed
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06601504
