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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Primary Central Nervous System Lymphoma

Intervention / Treatment
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* Drug: rituximab in combination with methotrexate, cytarabine and dexamethasone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 14-75 years old; KPS score ≥ 60 points or ECOG score ≤ 2 points; expected survival period of more than 3 months; CD20 positive; PCNSL confirmed by tissue biopsy pathology (limited to brain, spinal cord, meninges and eyes, without lymphoma involving other parts of the body); no chemotherapy contraindications (blood and physiological examination results <7 days); At least one measurable lesion according to the RECIST criteria; There are no other serious diseases that conflict with this plan; There is a possibility of follow-up; When using other anti-tumor drugs at different times during this treatment, bisphosphonate anti-bone transfer therapy and other symptomatic treatments may be applied; Can understand the situation of this study and sign the informed consent form. *: Pathological histology is subject to consultation by pathologists at provincial hospitals. Exclusion Criteria: Currently receiving other chemotherapy, radiotherapy and targeted therapy (chemotherapy within 3 weeks, radiotherapy within 2 weeks, or recovery from acute toxicity of any previous treatment); Pregnant or lactating women; There are any uncontrollable medical diseases (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia); combined with chemotherapy and other contraindications for chemotherapy; Those who have had other malignant tumors in the past; There are uncontrolled infected patients; Those who have a history of mental illness that is difficult to control; The investigator believes that it is not appropriate to participate in this test.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rituximab combined with formoterol, pemetrexed, dexamethasone<br>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) | Drug: rituximab in combination with methotrexate, cytarabine and dexamethasone<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ORR | Objective Responder Rate | up to 24 months | 
| PFS | Progression Free Survival | up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | up to 24 months | 
| adverse events | Number of patients with adverse events | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rituximab, fotemustine, pemetrexed, ORR, OS, PFS