CMOP±R in the Treatment of Untreated Non-Hodgkin's Lymphoma

Launched by THE FIRST AFFILIATED HOSPITAL OF SOOCHOW UNIVERSITY · Jun 30, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called CMOP±R for people who have been newly diagnosed with non-Hodgkin's lymphoma (NHL), a type of cancer that affects the lymphatic system. The goal of the trial is to see how safe and effective this treatment is. The trial is not yet recruiting participants, but it will involve adults aged 18 to 75 years who have a confirmed diagnosis of NHL and are expected to live for at least three more months. To be eligible, patients must have at least one measurable tumor or lymph node that meets certain size criteria and have a specific level of blood cell counts.

Participants in this trial can expect to receive the CMOP±R treatment and will be closely monitored for its effects. It's important to know that individuals with certain health issues—like serious heart problems, active infections, or other types of cancer—will not be allowed to join the study. This trial aims to gather valuable information that could help improve treatment options for patients with non-Hodgkin's lymphoma in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients fully understand this study, voluntarily participate and sign the informed consent (ICF);
• • Age: 18-75 years old;
• • Expected survival time ≥ 3 months;
• • Histopathologically diagnosed newly diagnosed non-Hodgkin's lymphoma;
• • Must have at least one evaluable or measurable lesion that meets the Lugano 2014 criteria: lymph node lesions, measurable lymph nodes must have a long diameter \>1.5cm; non-lymph node lesions, measurable extranodal lesions must have a long diameter \>1.0cm;
• • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-2.
• • Bone marrow function: Absolute neutrophil count (ANC) ≥1.5×10\^9/L, Platelet count (PLT) ≥75×10\^9/L, Hemoglobin(HB)≥ 80 g/L(Restriction may be relaxed in patients with bone marrow involvement, Absolute neutrophil count (ANC) ≥1.0×10\^9/L, Platelet count (PLT) ≥50×10\^9/L, Hemoglobin(HB)≥ 75g/L);
• • Liver and kidney function: serum creatinine ≤ 1.5 times the upper limit of normal value; AST and ALT ≤ 2.5 times the upper limit of normal value (for patients with liver invasion ≤ 5 times the upper limit of normal value); total bilirubin ≤ 1.5 times the upper limit of normal value (for patients with liver invasion ≤ 3 times the upper limit of normal value);
• Exclusion Criteria:
• • Subjects have previously received anthracyclic drug pretreatment;
• • Hypersensitivity to any study drug or its components;
• • Uncontrollable systemic diseases (such as advanced infection, uncontrollable hypertension, diabetes, etc.);
• • Heart function and disease meet one of the following conditions: a) long QTc syndrome or QTc interval \>480 ms; b) complete left bundle branch block, grade II or III atrioventricular block; c) Serious and uncontrolled arrhythmias requiring drug treatment; d) New York Heart Association grade ≥ III; e) Cardiac ejection fraction (LVEF) lower than 50%;f) A history of myocardial infarction, unstable angina pectoris, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically serious pericardial disease, or ECG evidence of acute ischemia or active conduction system abnormalities within 6 months before recruitment.
• • Active hepatitis B and C infection (positive hepatitis B virus surface antigen and more than 1x10\^3 copies/mL of hepatitis B virus DNA; more than 1x10\^3 copies/mL of hepatitis C virus RNA);
• • Human immunodeficiency virus (HIV) infection (positive HIV antibody);
• • Suffering from other malignant tumors in the past or at the same time (except for effectively controlled non-melanoma skin basal cell carcinoma, breast/cervix carcinoma in situ, and other malignant tumors that have been effectively controlled without treatment in the past five years);
• • Suffering from primary or secondary central nervous system (CNS) lymphoma or a history of CNS lymphoma at the time of recruitment;
• • Pregnant and lactating women and patients of childbearing age who are unwilling to take contraceptive measures;
• • Other researchers judge not to Eligibility to participate in this study.