Prospective study of therapeutic drug monitoring on the Busulfan-Thiotepa Regimen for Autologous Transplantation in Central Nervous System Malignant Lymphoma. (TDMB study)

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适应症

试验速览

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•This study is intended for patients who meet all of the following criteria.
•Have completed haematopoietic stem cell collection for ASCT
•Are aged 18 years or older at the time of consent
•Have demonstrated a reduction in central nervous system lesions of at least partial response (PR) on a brain MRI performed within 28 days of registration, compared to the time of diagnosis
•Have an ECOG PS of 0-2 as assessed within 14 days of registration
•Patients who meet all of the following criteria based on tests conducted within 14 days prior to registration
•AST and ALT are 3 times or less the upper limit of the facility's reference range
•gammaGTP is 2.5 times or less the upper limit of the facility's reference range
•Total bilirubin is 1.5 times or less the facility's reference range
•Creatinine is 1.5 times or less the facility's reference range
•Patients whose left ventricular ejection fraction (LVEF) was 50% or higher in a cardiac ultrasound examination performed within 56 days prior to registration
•Patients who, after receiving a full explanation regarding participation in this trial and having fully understood the details, have provided written informed consent of their own free will

•Patients meeting any of the following criteria will be excluded from the study.
•Patients with intraocular CNSL without brain lesions
•Patients with a pathological diagnosis of CNSL other than B-cell tumours
•Patients who have received any treatment (other than haematopoietic stem cell collection) for the primary disease within 14 days of registration
•Patients who have undergone ASCT within 6 months of registration
•Patients who have received a live vaccine within 84 days of registration
•Patients with concurrent malignancies
•Pregnant or breastfeeding patients
•Patients with poorly controlled infections
•Patients with poorly controlled diabetes
•Patients who have received other investigational drugs or clinical trial drugs within 3 months prior to the start of administration of the study drug
•Other patients deemed unsuitable as subjects by the principal (or co-) investigator

发起方

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