Evaluating ZRMT treatment for primary central nervous system lymphoma

A Prospective, Multicenter, Open-label, Single-arm Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of Primary Central Nervous System Lymphoma (PCNSL)

This study is testing a new combination treatment for people with primary central nervous system lymphoma to see if it is safe and effective.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Huai'an First People's Hospital (Academic / other)
• Drugs / interventions: radiation, Rituximab, Zanubrutinib, Methotrexate, zebutinib, Ibrutinib, Zanbrutinib, chemotherapy
• Locations: 1 site (Huai'an, Jiangsu)
• Trial ID: NCT06445257 on ClinicalTrials.gov

What this trial studies

This clinical trial is a prospective, multicenter, open-label, single-arm evaluation of the ZRMT regimen, which includes zanubrutinib, rituximab, methotrexate, and temozolomide, for treating primary central nervous system lymphoma (PCNSL). The study aims to assess the safety, tolerability, and preliminary efficacy of this treatment approach, which is particularly important given the aggressive nature of PCNSL and the limited effectiveness of current therapies. Participants will undergo an induction phase followed by a maintenance phase with zebutinib monotherapy. A total of 30 subjects are expected to be enrolled in this trial.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 75 years who have been histopathologically diagnosed with primary central nervous system diffuse large B-cell lymphoma.

Not a fit: Patients with a poor performance status or those with severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a low-toxicity and highly effective option for patients with primary central nervous system lymphoma.

How similar studies have performed: While the approach of combining these specific agents is novel, similar studies have shown promise in treating other forms of lymphoma with combination therapies.

Eligibility criteria

Inclusion Criteria:

* According to the 2016 WHO classification of hematopoietic and lymphoid tissue tumors, the patient has been histopathologically diagnosed with primary central nervous system diffuse large B-cell lymphoma.
* Age ≥18 years and ≤75 years, any gender.
* Performance status score (ECOG): 0-1.
* Male participants and reproductive-age females must use contraception during the study and for 3 months after the last dose.
* Reproductive-age females must have a negative serum or urine pregnancy test at screening.
* Expected survival of more than 3 months.
* Laboratory tests must meet the following criteria:Hematology: Hemoglobin (Hb) ≥80 g/L, absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet count (PLT) ≥75 × 109/L.Liver function: Serum total bilirubin (TBIL) ≤1.5 × upper limit of normal (ULN), aspartate aminotransferase (AST) ≤2.5 × ULN, alanine aminotransferase (ALT) ≤2.5 × ULN.Renal function: Creatinine clearance rate (Ccr) ≥50 mL/min.Coagulation function: International normalized ratio (INR) and prothrombin time (PT) ≤1.5 × ULN.Note: Patients who do not meet the above criteria may receive supportive treatment at the discretion of the investigator.
* The patient is aware of and voluntarily agrees to participate in the study and is able to comply with the scheduled visits and related procedures as specified in the protocol.

Exclusion Criteria:

* Patients who are determined by the investigator to be allergic, resistant, or intolerant to the drugs in the treatment regimen.
* Patients who have received any investigational drugs or radiation therapy within the past 4 weeks.
* Patients who have undergone major surgery within the past 4 weeks (excluding surgery related to the disease).
* Patients with severe infections within the past 4 weeks, as determined by the investigator, who are not suitable for treatment.
* Patients with a history of stroke or intracranial hemorrhage within the past 3 months, or active grade 3 or higher gastrointestinal bleeding.
* Patients who are pregnant or breastfeeding.
* Patients with impaired cardiac function or significant cardiac diseases, including but not limited to: a) myocardial infarction, congestive heart failure, or viral myocarditis within the past 6 months; b) symptomatic cardiac diseases requiring treatment intervention, such as unstable angina or arrhythmias; c) NYHA class II-IV heart function; d) echocardiographic ejection fraction (EF) below 50% or below the lower limit of the study center.
* Patients with a known history of human immunodeficiency virus (HIV) infection, primary immunodeficiency diseases, or active tuberculosis.
* Patients with poorly controlled hypertension or diabetes.
* Patients with active hepatitis B or hepatitis C infection (for HBsAg-positive or HBcAb-positive subjects, they can be included if HBV-DNA is not detected; for HCV antibody-positive subjects, they can be included if HCV-RNA is not detected).
* Patients with a history of malignant tumors that may affect the implementation of the trial protocol or result analysis (excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, ductal carcinoma in situ of the breast, localized gastric or intestinal mucosal carcinoma, and localized prostate cancer).
* Patients with active mental disorders, alcoholism, drug abuse, or substance abuse.
* Patients who are determined by the investigator to be unsuitable for participation in this study.

Where this trial is running

Huai'an, Jiangsu

• The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University（Huai'an First People's Hospital） — Huai'an, Jiangsu, China (Recruiting)

Study contacts

• Study coordinator: Chunling Wang

Conditions Primary Central Nervous System Lymphoma