A Study of Linperlisib (YY-20394) in Combination With Rituximab in Patients With Relapsed/Refractory Indolent NHL
Phase 1
Not yet recruiting
- Conditions
- Relapsed/Refractory Indolent NHL
- Interventions
- Drug: Linperlisib ； Rituximab
- Registration Number
- NCT06981988
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Brief Summary
The study is being conducted to evaluate the reasonable dosage, efficacy and safety of Linperlisib in combination with rituximab in subjects with relapsed/refractory (R/R) indolent non-hodgkin lymphoma(NHL) in adults.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
- Patients received at least 1 lines of systemic therapy
- Previously received anti- CD20 treatment
- Subjects must have at least one bi-dimensionally measurable lesion (nodal site Ldi > 1.5 cm or extranodal site Ldi > 1.0cm)
- Patients must have an acceptable organ function
Exclusion Criteria
- Previously treated with PI3K inhibitors
- Unresolved toxicity of CTCAE grade > 1 from prior anti-lymphoma therapy
- Chemotherapy or other antitumor therapy within 14 days before starting cycle one
- Significant concurrent medical disease or condition which according to the investigators' judgement
- Active hepatitis B, C or HIV infection
- Infection requiring treatment 2 weeks prior to the first dosing
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Linperlisib + Rituximab Linperlisib ； Rituximab -
- Primary Outcome Measures
Name Time Method MTD （Maximum tolerated dose）of Linperlisib（Stage 1） Subjects are evaluated for DLTs during the first 28-day cycle RP2/3D（Recommended Phase II/III Dose) of Linperlisib （Stage 1） The RP2/3D for Phase 2/3 will be selected at the end of Phase 1b, approximately 2 years Complete response rate (CRR) assessed by Investigator（Stage 2） up to 5 years Progression-free Survival assessed by Investigator （Stage 2） up to 5 years
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR) assessed by Investigator up to 5 years Duration of response (DOR) assessed by Investigator up to 5 years Incidence of Adverse Events (Linperlisib when combined with Rituximab) up to 5 years