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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Linperlisib + Rituximab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Linperlisib ï¼› Rituximab | Drug | Linperlisib ï¼› Rituximab |
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhenyu Xiao | Contact | 021-61053363 | zhenyu.xiao.zx7@hengrui.com |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| up to 5 years |