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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-05

Study Completion Date

2024-04-01

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

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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.

Conditions

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Primary Central Nervous System Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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)

Group Type EXPERIMENTAL

rituximab in combination with methotrexate, cytarabine and dexamethasone

Intervention Type 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)

Interventions

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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)

Intervention Type DRUG

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.

Minimum Eligible Age

14 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No