A Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of PCNSL

Launched by HUAI'AN FIRST PEOPLE'S HOSPITAL · Jun 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for patients with primary central nervous system lymphoma (PCNSL), a type of cancer that affects the brain and spinal cord. The treatment being studied is a combination of four medications called ZRMT (which includes Zanubrutinib, Rituximab, Methotrexate, and Temozolomide). The trial aims to determine how safe and effective this regimen is for people diagnosed with PCNSL, specifically those with diffuse large B-cell lymphoma.

To participate in this study, candidates must be between 18 and 75 years old and have a confirmed diagnosis of PCNSL. They should be in relatively good health and able to follow the study's requirements. Participants can expect to undergo an initial treatment phase followed by a maintenance phase, where they will receive ongoing care. It's important for potential participants to discuss any medical history or health issues with their doctor to ensure they meet the eligibility criteria. The study is currently recruiting participants, and those who join will contribute to important research that could lead to improved treatments for this challenging condition.

Gender

ALL

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.