NCT06832267 Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL
| NCT ID | NCT06832267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang Cancer Hospital |
| Condition | Primary Central Nervous System Lymphoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2025-02-14 |
| Primary Completion | 2027-02-13 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2025-02-14 with a primary completion date of 2027-02-13.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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 * Expected survival of more than 3 months. * Female patients of reproductive age should agree that birth control (such as intrauterine device, birth control pills, or condoms) must be used during the study period and for six months after completion; Having a negative serum pregnancy test within 7 days prior to study enrollment, and must be non-lactating; Male patients should agree to use contraception during the study period and for six months after the end of the study. Exclusion Criteria: * 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. * Patients who are pregnant or breastfeeding. * Current participation in other clinical studies, or initiation of study drugs administration less than 4 weeks after completion of previous clinical study treatment. * Patients with concomitant diseases that, in the investigator's judgment, may seriously endanger patients' safety or may interfere with the completion of the study, or are deemed unsuitable for inclusion for other reasons.
Contact & Investigator
Haiyan Yang
PRINCIPAL INVESTIGATOR
Zhejiang Cancer Hospital
Frequently Asked Questions
Who can join the NCT06832267 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Primary Central Nervous System Lymphoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06832267 currently recruiting?
Yes, NCT06832267 is actively recruiting participants. Contact the research team at yanghy@zjcc.org.cn for enrollment information.
Where is the NCT06832267 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT06832267 clinical trial?
NCT06832267 is sponsored by Zhejiang Cancer Hospital. The principal investigator is Haiyan Yang at Zhejiang Cancer Hospital. The trial plans to enroll 44 participants.