Overview

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

Status:
Recruiting
Trial end date:
2024-04-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mingzhi Zhang
Treatments:
BB 1101
Cytarabine
Dexamethasone
Dexamethasone acetate
Fotemustine
Methotrexate
Pemetrexed
Rituximab
Criteria
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.