Using RMTT regimen as first-line therapy for primary central nervous system lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the efficacy and safety of the Rituximab-Methotrexate-Temozolomide-Thiotepa (RMTT) regimen as a first-line treatment for patients diagnosed with primary central nervous system diffuse large B-cell lymphoma (PCNS DLBCL). Participants will be closely monitored for their response to the treatment and any potential side effects. The study focuses on patients who have not previously received systemic therapy for their condition. The goal is to determine if this combination therapy can improve outcomes for these patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Zhejiang Cancer Hospital
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Principal investigator: Haiyan Yang — Zhejiang Cancer Hospital
• Study coordinator: Haiyan Yang, PhD
• Email: yanghy@zjcc.org.cn
• Phone: 0571-88122192

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Testing a four-drug regimen (methotrexate, rituximab, sintilimab, pirtobrutinib) versus investigator-selected care for newly diagnosed PCNSL

  This trial will try a combination of methotrexate, rituximab, sintilimab and pirtobrutinib as first treatment for adults with newly diagnosed primary central nervous system lymphoma to see if it increases complete remissions and is safe compared with standard doctor-selected treatments.

  Recruiting at 3 sites Phase 2 Tongji Hospital · Xiamen, Fujian and 3 other locations · NCT07350850

• Orelabrutinib Combined With Teniposide, Rituximab and Methotrexate for Newly Diagnosed PCNSL

  In this study, adults with newly diagnosed primary CNS lymphoma try different induction regimens to see which one works best before consolidation therapy.

  Recruiting at 9 sites Phase 2/3 Huashan Hospital · Beijing and 14 other locations · NCT07185373

• Combination treatment for newly diagnosed primary central nervous system lymphoma

  This study is testing a new combination of treatments for people with newly diagnosed primary central nervous system lymphoma to see if it helps them respond better and live longer.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hanzhou, Zhejiang · NCT05600660

• Combination treatment for primary central nervous system lymphoma

  This study is testing a new combination of medications to see if it can help people with primary central nervous system lymphoma feel better and improve their treatment outcomes.

  Recruiting Phase 2 Henan Cancer Hospital · Zhengzhou, Henan · NCT04737889

• R-PMDT Regimen for Newly Diagnosed PCNSL

  This study tests the R-PMDT treatment approach in people newly diagnosed with primary CNS lymphoma to see how many respond.

  Recruiting Phase 2 Institute of Hematology & Blood Diseases Hospital, China · Tianjin · NCT07604987

• PD‑1 blocker with rituximab, high‑dose methotrexate, and orelabrutinib for newly diagnosed primary or secondary CNS lymphoma

  This trial will test whether combining a PD‑1 blocker with rituximab, high‑dose methotrexate, and orelabrutinib helps people with newly diagnosed primary or secondary central nervous system diffuse large B‑cell lymphoma.

  Recruiting Phase 2 The First Affiliated Hospital with Nanjing Medical University · Nanjing, Jiangsu · NCT07410520

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.