NCT06832267

Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL

A Single-center, Single-arm Phase II Trial of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for Primary Central Nervous System Diffuse Large B-cell Lymphomas(PCNS DLBCL)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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)

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT)	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).

Timeline

• Start date: 2025-02-14
• Primary completion: 2027-02-13
• Completion: 2028-02-13
• First posted: 2025-02-18
• Last updated: 2025-02-18

Locations

1 site across 1 country: China