NCT04516655

A Phase II Trail of Chidamide ,Rituximab and Methotrexate in Lymphoma Patients

A Phase II， Single-arm Trail of Chidamide Combined With Rituximab and High-dose Methotrexate in Previously Untreated Patients With Primary Central Nervous System Lymphoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy, safety and patient reported outcomes of chidamide 20 mg biw PO day1-14 and rituximab 375 mg/m2 IV given on day 1 and methotrexate 3.5g/m2 IV given on day 2 of every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma. The primary study endpoint will be complete response (CR) rate as assessed by the investigator. The hypothesis is previously untreated patients with primary central nervous system lymphoma could achieve a CR rate of 80% with C-R-HDMTX.

Conditions

• Central Nervous System Lymphoma

Interventions

Type	Name	Description
DRUG	chidamide combined with rituximab and high-dose methotrexate	chidamide 20 mg biw PO day1-14 and rituximab 375 mg/m2 IV given on day 1 and methotrexate 3.5g/m2 IV given on day 2 of every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma

Timeline

• Start date: 2020-09-01
• Primary completion: 2021-09-01
• Completion: 2023-08-30
• First posted: 2020-08-18
• Last updated: 2020-08-18