Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorZhejiang Cancer Hospital
About this trial
This study aims to observe and explore the efficacy and safety of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as first-line therapy for primary central nervous system diffuse large B-cell lymphomas(PCNS DLBCL)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients voluntarily joined the study, signed the informed consent, and had good compliance;
Patients with 18 Years to 75 Years(at the time of signing the informed consent); Eastern Cooperative Oncology Group Performance Status (ECOG-PS) score: 0-3;
Patients with histopathologically confirmed newly diagnosed primary central nervous system diffuse large B-cell lymphoma, and there were intracranial evaluable lesions (long diameter greater than 1.5cm, short diameter greater than 1cm);
Patients who have not received any systemic therapy, except those who use hormones to control complications
Disqualifiers
Patients who have previously received antitumor therapy or targeted therapy
Patients who have undergone major surgery within the past 3 weeks .
Presence of severe or uncontrolled comorbid conditions including, but not limited to, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina, active peptic ulcer disease, or severe hemorrhagic disorders such as hemophilia A, hemophilia B, von Willebrand disease, or history of spontaneous bleeding requiring transfusion or other medical interventions.
Any active infection requiring systemic antimicrobial therapy within 14 days before starting study treatment, including, but not limited to, bacterial, fungal, and viral infections.
Trial design
Design model
Single group
Treatments tested in this trial
Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT)
DrugRituximab: 375 mg/m2 intravenously on day 3,7; Methotrexate: 1.5-3.5 g/m2 intravenously on day 1,14(≤65 ,3.5g/m2；\>65,1.5g/m2); Temozolomide 150 mg/m2 on days 3-7； Thiotepa:40 mg/m2 intravenously on day 17。 Treatment will be given for 4 cycles（28 days for each cycle）, and patients who achieve a CR or better can choose to undergo ASCT or WBRT(23.4Gy).
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Complete Remission Rate（CRR）
The proportion of subjects who achieves a best overall response of CR
Time frame
Up to 16 weeksSecondary outcomes
1
Overall Response Rate (ORR)
The proportion of subjects who achieves a best overall response of CR or PR.
Time frame
Up to 16 weeks2
Progression-Free Survival（PFS）
From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first
Time frame
Up to 2 years3
overall survival(OS)
The overall survival time refers to the time from therapy to death due to any cause.
Time frame
Up to 2 years4
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Time frame
From date of first day of treatment until 30 day after last treatmentSponsors and contacts
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Source ClinicalTrials.gov