High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnose… (NCT06646211) | Clinical Trial Compass
Not Yet RecruitingPhase 2
High-dose Methotrexate Combined with Thiotepa and Zanubrutinib in the Treatment of Newly Diagnosed PCNSL (MTZ)
China30 participantsStarted 2025-01-01
Plain-language summary
This is a phase â…¡ 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
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Men and woman who are 18 to 70 years of age
✓. Histologically documented PCNSL
✓. ECOG performance status ≤ 2
✓. Life expectancy of \> 3 months
✓. Imaging show at least one measurable lesion in the central nervous system.
✓. Adequate bone marrow and organ function shown by:
✓. Absolute neutrophil count (ANC) ≥ 1.5 x 10\^9/L
✓. Platelets ≥ 75 x 10\^9/L and no platelet transfusion within the past 14 days
Exclusion criteria
✕. Diagnosed with a malignant tumor other than PCNSL or has received treatment, except for the following cases:
✕. 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
What they're measuring
1
Overall Response Rate (ORR) at the end of TZ / MTZ treatment, Investigator-Assessed
✕. Uncontrolled hypertension despite optimal medical management (per investigators assessment)
✕. Patient has poorly controlled diabetes (per investigators assessment)
✕. Patient is known to have an uncontrolled active systemic infection (\>CTCAE grade 2) and recent infection requiring intravenous anti-infective treatment that was completed ≤14 days before the first dose of study drug