RecruitingNot ApplicableNCT06445257
A Clinical Study Evaluating the Safety and Efficacy of ZRMT Regimen in the Treatment of PCNSL
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)
Sponsor
Huai'an First People's Hospital
Enrollment
30 participants
Start Date
Sep 15, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
This study is a prospective, multicenter, open-label, single-arm clinical trial evaluating the safety and efficacy of the ZRMT (Zanubrutinib-Rituximab-Methotrexate-Temozolomide) regimen in the treatment of primary central nervous system lymphoma (PCNSL) with diffuse large B-cell lymphoma. This study includes an induction phase for PCNSL ± ASCT and a sequential maintenance phase.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria8
- 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 Criteria13
- 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.
Interventions
DRUGzanubrutinib 160 mg BID orally
The ZRMT induction and maintenance regimen
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06445257
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