High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed PCNSL (MTZ)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorSun Yat-sen University
About this trial
This is a phase Ⅱ clinical study of Zanubrutinib(Z) in combination with methotrexate (M) and thiotepa(T) in treating newly diagnosed primary CNS lymphoma (PCNSL).
The purpose of the study is to test the efficacy and tolerability of a combination treatment of MTZ regimen in treating patients who have newly diagnosed PCNSL
Eligibility criteria
Qualifiers
Men and woman who are 18 to 70 years of age
Histologically documented PCNSL
ECOG performance status ≤ 2
Life expectancy of > 3 months
Disqualifiers
Received curative treatment and has no known active disease at least 3 years or more before screening for enrollment.
Fully treated non-melanoma skin cancer or malignant lentigo, with no evidence of disease.
Fully treated carcinoma in situ, with no evidence of disease currently.
Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure (New York Heart Association > Class 2), unstable angina, or myocardial infarction within 6 months of screening, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
Trial design
Treatments tested in this trial
- Zanubrutinib , Thiotepa
- Methotrexate , Thiotepa and Zanubrutinib
- ASCT±Zanubrutinib
Treatment groups
30 Participants
are divided into 1 treatment groupLocations
1Sun Yat-sen University Cancer Center510060, GuangzhouGuangdong, China
Sponsors and collaborators
Sun Yat-sen University
Lead sponsor
Source ClinicalTrials.gov