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NCT Number: NCT06832267

Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for PCNS DLBCL

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)

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT)

Drug

Rituximab: 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).

Primary outcomes

  1. Complete Remission Rate(CRR)

    Time frame: Up to 16 weeks

    The proportion of subjects who achieves a best overall response of CR

Secondary outcomes

  1. Overall Response Rate (ORR)

    Time frame: Up to 16 weeks

    The proportion of subjects who achieves a best overall response of CR or PR.

  2. Progression-Free Survival(PFS)

    Time frame: Up to 2 years

    From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first

  3. overall survival(OS)

    Time frame: Up to 2 years

    The overall survival time refers to the time from therapy to death due to any cause.

  4. Adverse event rate

    Time frame: From date of first day of treatment until 30 day after last treatment

    The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Haifeng Yu, MD

CONTACT

[email protected]

15157155533

Haiyan Yang, PhD

CONTACT

[email protected]

0571-88122192

Sponsors and collaborators

Lead sponsor

Zhejiang Cancer Hospital

Other

Registry information

Official study title

A Single-center, Single-arm Phase II Trial of Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) Regimen As First-line Therapy for Primary Central Nervous System Diffuse Large B-cell Lymphomas(PCNS DLBCL)

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Feb 18, 2025
Registry last updated
Feb 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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