Trials / Active Not Recruiting
Active Not RecruitingNCT06601504
Study of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Relapsed/Refractory DLBCL
A Phase II Randomized, Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HMPL-760 Plus R-GemOx Versus Placebo Plus R-GemOx in Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma(R/R DLBCL)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 61 (actual)
- Sponsor
- Hutchmed · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | HMPL-760 planned dose 1 | HMPL-760 planned dose 1 daily (QD) orally |
| DRUG | R-GemOx | 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. |
| DRUG | HMPL-760 placebo planned dose 1 | HMPL-760 placebo planned dose 1 daily (QD) orally |
| DRUG | HMPL-760 planned dose 2 | HMPL-760 planned dose 2 daily (QD) orally |
| DRUG | HMPL-760 placebo planned dose 2 | HMPL-760 placebo planned dose 2 daily (QD) orally |
Timeline
- Start date
- 2024-11-05
- Primary completion
- 2026-05-12
- Completion
- 2026-11-12
- First posted
- 2024-09-19
- Last updated
- 2025-06-06
Locations
16 sites across 1 country: China
Source: ClinicalTrials.gov record NCT06601504. Inclusion in this directory is not an endorsement.