A Phase II/III Study of Linperlisib Plus CHOP Versus CHOP in Patients With Newly Diagnosed Peripheral T Cell Lymphoma
NCT06548347 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 606
Last updated 2024-08-12
Summary
This is a Phase II/III, international multiple center study to evaluate the efficacy, safety, and PK of Linperlisib plus CHOP and CHOP in adult patients with Newly Diagnosed Peripheral T Cell Lymphoma.
Conditions
- Peripheral T Cell Lymphoma
Interventions
- DRUG
-
Linperlisib
Linperlisib at 80 mg orally once daily (QD) or 60mg orally once daily (QD) plus CHOP, placebo at 80mg or 60 mg orally once daily (QD) plus CHOP for 6 cycles
Sponsors & Collaborators
-
Shanghai YingLi Pharmaceutical Co. Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-10
- Primary Completion
- 2024-12-31
- Completion
- 2029-09-30
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