indolent non Hodgkin B-cell Lymphoma
Conditions
Interventions
Experimental group:Bendamustine combined with rituximab
Sponsors
The Hospital Affiliated of Qingdao University
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. According to the 2016 World Health Organization (WHO) disease classification, it is confirmed in histopathology/cytology* as relapsed or refractory follicular lymphoma (grade 1, 1 and 3a) and marginal zone B cell lymphoma tumor. And the subjects cannot tolerate or are unwilling to receive intense chemotherapy; they have previously received up to two-line treatment, in which stem cell transplantation is regarded as the first-line treatment. 2. Aged 16 to 70 years; 3. Estimated survival time > 3 months; 4. ECOG =90g/L; 2) ANC>=1.5x10^9/L; 3) PLT>=75x10^9/L; (2) Biochemical inspection: 1) TBIL= 50mL/min (Cockcroft-Gault formula); (3) Coagulation function (unless the subject is receiving anticoagulant therapy, and the coagulation parameters (PT/INR and APTT) at the time of screening are within the expected range of anticoagulant therapy): 1) International normalized ratio (INR)<=1.5xULN; 2) Activated partial thromboplastin time (APTT)<=1.5xULN. 6. There must be at least 1 evaluable or measurable lesion that meets the Lugano2014 standard [evaluable lesion: PET/CT examination shows increased lymph node or extranodal local uptake (higher than the liver) and PET/CT characteristics are consistent with lymphoma manifestations. Measurable lesions: nodular lesions longer than 15mm or extranodal lesions longer than 10mm) and FDG-PET positive lesions]; 7. Women who are not breastfeeding or pregnant, agree not to become pregnant during the study period and the following 12 months. The male patient agrees that his spouse will not become pregnant during the study period and the following 12 months; 8. Voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Diagnosed as follicular lymphoma(3b), transformed FL and MZL; 2.Serious systemic infections or local infections during the 2 months before screening; 3.Patients diagnosed as CNS, testicular or mammary lymphoma; 4.Any prior exposure to zanubrutinib, chidamide, lenalidomide, bendamustine agents; 5.Previous allogeneic stem cell transplant or allogeneic organ transplantation; 6.Previous autologous stem cell transplant within 6 months; 7.Previous major surgery and live vaccine injection within 28 days; 8.Has enrolled in any other trials during 3 months prior to screening or concurrently enrolled in any other trials; 9.Uncontrolled internal medicine disease(including uncontrolled diabetes, severe incompetence cardiac, lung, liver and pancreas); 10.Human immunodeficiency virus (HIV)-positive patients; 11.Rejecting adopting reliable contraceptive method in pregnancy or lactation period; 12.History of cancer in 5 years before screening., including solid tumors and hematological malignancies (except basal cell and in situ squamous cell carcinomas of the skin that have been excised and resolved); 13.Patients combined with hemophagocytic syndrome; 14.With no legal capacity, medical or ethical reasons affecting research proceeding; 15.Other psychological conditions that prevent patients from participating in research or signing informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate ;Progression-free Survival ;Overall Survival; | — |
Countries
China
Contacts
Public ContactXue Hongwei
The Hospital Affiliated of Qingdao University
Outcome results
None listed