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

Sponsor
Fudan University
Study ID
NCT04516655
Phase
PHASE2
Status
Unknown

Conditions

  • Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 1, 2020
Status verified
Aug 2020
Primary completion
Sep 1, 2021
Completion
Aug 30, 2023

Study Design

Enrollment
51 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: C-R-MTX
    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

Primary Outcome Measure

CR rate [ Time Frame: up to 18 weeks ]

Central Contacts

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