lymphoma
Conditions
Interventions
Group 1:Combined with Zebutinib
Group 2:Not combined with Zebutinib
Sponsors
Taian City Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Volunteer to participate in clinical research; fully understand and understand the study and sign the ICF; willing to follow and able to complete all research steps; 2. Histologically confirmed diffuse large B-cell lymphoma (DLBCL); 3. Age >= 18 years, 80 years and status score = 1.0×10^9/L; platelet (PLT) >= 50×10^9/L; hemoglobin > 80 g/L; AST/SGOT and ALT/SGPT = 40 mL/min (estimated by Cockcroft-Gault formula); international normalized ratio (INR) <= 1.5 x ULN, prothrombin time (PT), activated partial thrombin time (APTT) <= 1.5 x ULN (unless subject is receiving anticoagulant therapy and PT and APTT are taking anticoagulant therapy at the time of screening); 9. Participants may be enrolled only after toxicity from prior treatment has returned to a Standard for General Terminology for Adverse Events (CTCAE V5.0) score <1 or baseline. Grade 2 toxicities (such as thrombocytopenia, anemia, neurotoxicity, hair loss, and hearing loss) that are irreversible and not expected to worsen during the study period as a result of prior antitumor therapy should be evaluated by the investigator and approved by the investigator before inclusion; 10. Before starting treatment, two pregnancy tests (at least one of which should be serological pregnancy tests) must be performed on fertile female patients and the results must be negative. The first trial must be conducted within 10-14 days prior to lenalidomide treatment and the second trial must be conducted within 24 hours prior to lenalidomide treatment; 11. Fertile women must agree to use reliable contraception throughout the study period and for at least 90 days after the final dose of zbrutinib, or for 12 months after the final dose of rituximab, whichever is longer. Male patients using the study drug were not allowed to donate sperm throughout the study, for at least 90 days after the final dose of Zbrutinib, or for 12 months after the final dose of rituximab, whichever is longer.
Exclusion criteria
Exclusion criteria: 1. Patients who have been diagnosed with other diseases of the blood system, not lymphoma; 2. Other active malignancies requiring concurrent treatment; 3. Major surgery within 4 weeks before screening; 4. The toxicity of previous anticancer therapy was still >= grade 2 when enrolled (except for alopecia, ANC, hemoglobin and platelet toxicity). For ANC, hemoglobin and platelet-related requirements, please follow inclusion criteria 9; 5. A history of other active malignant diseases within the 2 years prior to study entry was acceptable if: (1) Adequately treated carcinoma in situ of the cervix; (2) Local skin basal cell carcinoma or squamous cell carcinoma; (3) Previous malignant diseases that are under control and have undergone local radical treatment (surgical or other forms); 6. Clinically significant cardiovascular disease, including: (1) Myocardial infarction within 6 months prior to screening; (2) Unstable angina within 3 months before screening; (3) Clinically significant arrhythmias (such as persistent ventricular tachycardia, ventricular fibrillation, tip torsion ventricular tachycardia); (4) QTcF (corrected by Fridericia formula) > 480 msec; (5) A history of second degree type II atrioventricular (AV) block or third degree atrioventricular block; (6) Class III or IV congestive heart failure as defined by the New York Heart Association (NYHA); 7. A history of severe hemorrhagic disease, such as hemophilia A, hemophilia B, von Willebrand disease, or spontaneous bleeding requiring blood transfusion or other medical intervention. A history of stroke or intracranial hemorrhage within 6 months prior to initial drug administration; 8. Inability to swallow capsules or medical conditions that significantly affect gastrointestinal function, such as malabsorption syndrome, removal of the stomach or small intestine, symptomatic inflammatory bowel disease, or partial or complete intestinal obstruction; 9. Uncontrolled systemic infections that require intravenously administered parenteral anti-infective therapy; 10. Known human immunodeficiency virus (HIV) infection or the following serological status suggestive of active hepatitis B or C virus infection: (1) Hepatitis B surface antigen (HBsAg) positive or Hepatitis B core antibody (HBcAb) positive. Patients with HBcAb positive but HBsAg negative hepatitis B virus (HBV) DNA (<20 IU/mL) are not detectable and are willing to undergo monthly HBV reactivation monitoring; (2) Hepatitis C virus (HCV) antibody positive. Patients with HCV antibodies can be enrolled if HCV RNA is not detected; 11. Allergic constitution or allergy to zbrutinib and rituximab; 12. Pregnant or lactating women; 13. The presence of any life-threatening disease, medical condition, or organ system dysfunction that the investigator believes could affect the safety of the subject or pose a risk to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Partial remission and complete remission;Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival time;Overall survival rate; | — |
Countries
China
Contacts
Public ContactWang Ling
Department of Hematology, Taian City Central Hospital, Shandong
Outcome results
None listed