ZSDT for the Treatment of R/R Mantle Cell Lymphoma After BTK Inhibitor Failure: a Multi-center Prospective Clinical Trial

Korábbi kezelés

• Previous allergies to any of the medications in the regimen;
• There are drug-related contraindications to treatment in the protocol;

Más betegség

• The researchers believe that major diseases can cause interference in the trial.;
• People with severe mental illness;
• Other serious diseases that may limit the subject's participation in this trial, such as: uncontrolled diabetes mellitus; Severe cardiac insufficiency (NYHA classification II or above); Acute coronary syndrome within the past 6 months; Coronary revascularization such as stenting, coronary artery bypass surgery, and other heart and large vessel related surgeries in the past 6 months; Severe arrhythmias include frequent premature ventricular episodes, ventricular tachycardia, rapid atrial fibrillation/atrial flutter, and severe bradycardia. Uncontrolled hypertension: systolic blood pressure > 150 mmHg, diastolic blood pressure > 100 mmHg. Gastric ulcer (gastric ulcer judged by the investigator to be at risk of perforation); Active autoimmune disease (e.g., systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, autoimmune thrombocytopenia, etc.); Severe respiratory diseases (such as obstructive pulmonary disease and history of bronchospasm), etc.;
• Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer test is not within the normal reference value; Those who are positive for hepatitis C virus (HCV) antibody and positive for hepatitis C virus (HCV) RNA in peripheral blood; Those who are positive for human immunodeficiency virus (HIV) antibodies; Those who test positive for syphilis.

Egyéb

• Refusing to take blood samples;
• Pregnant and lactating women;
• Combined with other tumors.;
• Participating in other clinical trials;
• In the opinion of the investigators, it is not suitable for enrollment;

• Ages 18-70, ECOG score 0-2(including ages 18 and 70);
• Overall Survival > 6 months;
• The diagnosis of mantle cell lymphoma was confirmed by histopathology. 4.At least one measurable lesion;
  • 5.Acceptable hematologic parameters, no contraindications to chemotherapy, absolute neutrophil ≥1.0 × 10 \^ 9 L, platelet ≥75 × 10 \^ 9 L, hemoglobin ≥80 g/L (except for patients with bone marrow infiltration) 6.Liver function: direct bilirubin ≤1.5 × upper limit , Alanine transaminase or aspartate transaminase ≤2.5 × upper limit , Alkaline phosphatase≤3 × ULN in patients without non-bone involvement 7.Renal function: serum creatinine ≤1.5 ×ULN 5; 8.Women of Childbearing Potential (WOBCP) or men and their WOBCP partners should agree to take effective contraceptive measures from the signing of ICF and WOBCP must undergo a serum pregnancy test within seven days before the first medication and the results are negative; 9.Recurrent refractory patients after BTK inhibitor treatment; 10.The subjects voluntarily participate the study.