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

  • STATUS
    Recruiting
  • End date
    Apr 1, 2024
  • participants needed
    20
  • sponsor
    Mingzhi Zhang
Updated on 23 January 2021

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

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.

Details
Condition Primary Central Nervous System Lymphoma, Central Nervous System Lymphoma, Primary CNS Lymphoma, cns lymphoma
Treatment rituximab in combination with methotrexate, cytarabine and dexamethasone
Clinical Study IdentifierNCT04083066
SponsorMingzhi Zhang
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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