Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to observe and explore the efficacy and safety of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as first-line therapy for primary central nervous system diffuse large B-cell lymphomas(PCNS DLBCL)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) | Experimental | Rituximab: 375 mg/m2 intravenously on day 3,7; Methotrexate: 1.5-3.5 g/m2 intravenously on day 1,14(≤65 ,3.5g/m2;>65,1.5g/m2); Temozolomide 150 mg/m2 on days 3-7; Thiotepa:40 mg/m2 intravenously on day 17。 Treatment will be given for 4 cycles(28 days for each cycle), and patients who achieve a CR or better can choose to undergo ASCT or WBRT(23.4Gy). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) | Drug | Rituximab: 375 mg/m2 intravenously on day 3,7; Methotrexate: 1.5-3.5 g/m2 intravenously on day 1,14(≤65 ,3.5g/m2;>65,1.5g/m2); Temozolomide 150 mg/m2 on days 3-7; Thiotepa:40 mg/m2 intravenously on day 17。 Treatment will be given for 4 cycles(28 days for each cycle), and patients who achieve a CR or better can choose to undergo ASCT or WBRT(23.4Gy). |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Remission Rate(CRR) | The proportion of subjects who achieves a best overall response of CR | Up to 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | The proportion of subjects who achieves a best overall response of CR or PR. | Up to 16 weeks |
| Progression-Free Survival(PFS) | From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haiyan Yang, PhD | Contact | 0571-88122192 | yanghy@zjcc.org.cn | |
| Haifeng Yu, MD | Contact | 15157155533 | yuhaifeng5533@dingtalk.com |
| Name | Affiliation | Role |
|---|---|---|
| Haiyan Yang | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Up to 2 years |
| overall survival(OS) | The overall survival time refers to the time from therapy to death due to any cause. | Up to 2 years |
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | From date of first day of treatment until 30 day after last treatment |