Status:
RECRUITING
Obinutuzumab, Zanubrutinib, and Lenalidomide Followed Short-Cycle of Obinutuzumab and Cytarabine in Newly Diagnosed Mantle Cell Lymphoma
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Mantle Cell Lymphoma
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study aims to preliminarily explore the efficacy and safety of the combination of Obinutuzumab and Zanubrutinib plus Lenalidomide (ZGR) followed by a short cycle of cytarabine and Obinutuzumab in...
Detailed Description
Based on the clinical need for first-line treatment of MCL, this study proposed to enroll 39 patients with MCL who have not previously received any systemic therapy for MCL. All patients were treated ...
Eligibility Criteria
Inclusion
- 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:
- a) 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.
Exclusion
- 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)
- 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;
- 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);
- 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.
Key Trial Info
Start Date :
July 18 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT06504199
Start Date
July 18 2024
End Date
December 31 2028
Last Update
August 9 2024
Active Locations (2)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020
2
Institute of Hematology and Blood Diseases Hospital ,Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, China, 300020