Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma

Korábbi kezelés

• Previous use of investigational drugs;
• Any active systemic viral, bacterial, or fungal infection requiring antimicrobial therapy within 2 weeks prior to the first dose of study drug;
• Use of immunosuppressive agents, excluding nasal sprays and inhaled corticosteroids or physiological doses of systemic steroids (i.e., no more than 20 mg/day prednisone or its equivalent) within 7 days prior to the first dose of study drug
• Allergic reactions, anaphylactic reactions and adverse drug reactions
  • Severe allergic reactions to other monoclonal antibodies;
  • Allergy or intolerance to infusion;
  • Patients with a history of serious allergy to the investigational drug or its preventive medication;

Más betegség

• Known central nervous system disease such as brain or meninges, including central nervous system lymphoma.
• Congestive heart failure, Class III or IV (New York Heart Association, NYHA);
• Other primary malignancies within the last 3 years (except non-melanoma skin cancer, curatively treated localized prostate cancer, carcinoma in situ of the cervix, or squamous epithelial endothelial lesions on PAP smear)
• Any condition that, in the opinion of the investigator, may jeopardize the subject or may render the subject unable to meet or perform the study requirements;
• Other conditions that the investigator considers inappropriate for entry into this study.

Laborértékek

• Physical examination and laboratory findings
  • Patients with congenital or acquired immunodeficiency, such as active hepatitis B virus (HBV DNA ≥ 500 IU/mL), hepatitis C (hepatitis C antibody positive, and HCV-RNA higher than the lower limit of detection of the analytical method) or combined hepatitis B and C co-infection;
  • Pregnant or lactating women; patients with fertility are unwilling or unable to take effective contraceptive measures;
  • Known history of positive human immunodeficiency virus (HIV) test or known acquired immunodeficiency syndrome (AIDS);

• Aged 18 to 80 years, male or female;
• Patients with pathologically (histologically or cytologically) confirmed MCL and at least one measurable lesion by Lugano criteria;
• No prior systemic therapy for MCL;
• Eastern Cooperative Oncology Group (ECOG) score of 0-2 points;
• Normal function of vital organs, i.e. meeting the following criteria:
  • Blood routine examination must be in accordance with (no blood transfusion, no use of hematopoietic factors and no use of drugs for correction within 14 days): i. Absolute neutrophil count (ANC) ≥ 1 × 10＾9/L; ii. Platelet count (PLT) ≥ 75 × 10＾9/L; b) Chemistry panel must meet the following criteria: i. Total bilirubin (TBIL) ≤ 2.0 × upper limit of normal (ULN); ii. Glutamic pyruvic transaminase (ALT), glutamic oxaloacetic transaminase (AST) ≤ 2.0 × ULN iii. Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula); c) Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;
• Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the start of study medication and are willing to use a medically recognized highly effective contraceptive method (e.g., intrauterine device, contraceptive pill, or condom) during the study and within 6 months after the last dose of study drug; male subjects with partners of childbearing potential should be surgically sterile or agree to use an effective method of contraception during the study and within 6 months after the last dose of study drug;
• The subjects voluntarily participate in the study and sign the informed consent form. They have good compliance and cooperate in the follow-up.