NCT04083066

Open Randomized Prospective Clinical Study of R-FPD Versus R-MAD Regimen in the Treatment of Primary Central Nervous System Lymphoma

Open Randomized Prospective Clinical Study of Rituximab Combined With Fotemustine, Pemetrexed, Dexamethasone Versus Rituximab Plus Methotrexate, Cytarabine, and Dexamethasone in the Treatment of Primary Central Nervous System Lymphoma

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Mingzhi Zhang · Academic / Other
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Comparison of the efficacy and safety of rituximab combined with fotemustine, pemetrexed, dexamethasone and rituximab in combination with methotrexate, cytarabine and dexamethasone as first-line regimens in the treatment of primary central nervous system lymphoma

Detailed description

This is an open, randomized, prospective, multicenter clinical study designed to compare the efficacy and safety of R-FPD and R-MAD as first-line regimens in the treatment of primary central nervous system lymphoma. A total of 20 patients plan to participate in the study. The primary endpoints were objective response rate (ORR) and progression-free survival (PFS) and secondary endpoints including overall survival (OS), and adverse events.

Conditions

• Primary Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	rituximab in combination with methotrexate, cytarabine and dexamethasone	Rituximab 375mg/m2D0 is soluble in 0.9% NS concentration 1mg/ml, micro pump is pumped in 4h HD-methotrexate 3.5g/m2 D1 dissolved in 0.9% NS intravenous drip HD-cytarabine 1g/m2 Q12H D2-3 Dissolved in 250ml 5% GS intravenously Dexamethasone 40mg D1-5 is dissolved in 100ml 5% GS intravenous drip (21 days is a cycle)

Timeline

• Start date: 2019-09-05
• Primary completion: 2023-04-01
• Completion: 2024-04-01
• First posted: 2019-09-10
• Last updated: 2019-09-10

Locations

1 site across 1 country: China