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

Sponsor
Mingzhi Zhang
Study ID
NCT04083066
Phase
PHASE4
Status
Unknown

Conditions

  • Primary Central Nervous System Lymphoma

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • rituximab in combination with methotrexate, cytarabine and dexamethasone — DRUG
    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)

Study Details

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

Key Dates

Start date
Sep 5, 2019
Status verified
Sep 2019
Primary completion
Apr 1, 2023
Completion
Apr 1, 2024

Study Design

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

Arms

  • Experimental: Rituximab combined with formoterol, pemetrexed, dexamethasone
    Rituximab 375mg/m2D0 is soluble in 0.9% NS, concentration 1mg/ml, micro pump is pumped for 4h Fotemustine 100mg/m2 D1 dissolved in 250mL 0.9% NS, intravenously for 1h, protected from light Pemetrexed 600mg/m2 D1 dissolved in 100ml 0.9% NS, intravenously 1h Dexamethasone 40mg D1-5 Dissolved in 100 ml 5% GS, intravenously (21 days is a cycle)

Primary Outcome Measure

ORR [ Time Frame: up to 24 months ]

Central Contacts

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