Relapsed/Refractory Indolent NHL
Conditions
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.
Interventions
DRUGLinperlisib ； Rituximab
Linperlisib ； Rituximab
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients received at least 1 lines of systemic therapy 2. Previously received anti- CD20 treatment 3. Subjects must have at least one bi-dimensionally measurable lesion (nodal site Ldi \> 1.5 cm or extranodal site Ldi \> 1.0cm) 4. Patients must have an acceptable organ function
Exclusion criteria
1. Previously treated with PI3K inhibitors 2. Unresolved toxicity of CTCAE grade \> 1 from prior anti-lymphoma therapy 3. Chemotherapy or other antitumor therapy within 14 days before starting cycle one 4. Significant concurrent medical disease or condition which according to the investigators' judgement 5. Active hepatitis B, C or HIV infection 6. Infection requiring treatment 2 weeks prior to the first dosing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Duration of response (DOR) assessed by Investigator | up to 5 years |
| Incidence of Adverse Events (Linperlisib when combined with Rituximab) | up to 5 years |
| Objective Response Rate (ORR) assessed by Investigator | up to 5 years |
Contacts
Primary ContactZhenyu Xiao
Outcome results
None listed