Overview
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
Description
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.
Eligibility
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.