Diffuse Large B Cell Lymphoma
Conditions
Keywords
DLBCL, zanubrutinib, maintenance
Brief summary
This single-arm, prospective clinical study will evaluate the efficacy and safety of Zanubrutinib-based maintenance therapy for post-remission in newly diagnosed DLBCL who are intolerant to first-line intensive chemotherapy.
Interventions
DRUGZanubrutinib
160 mg bid, po, day 1-21, a maximum of 2 years.
DRUGLenalidomide
25 mg qd, po, day 1-10, a maximum of 2 years.
Sponsors
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients were informed about this study and voluntarily signed written informed consent 2. Patients were intolerant first-line intensive chemotherapy, including R-CHOP or R-DA-EPOCH: a) age≧70 years, or unfit or frail according to CGA; b) ECOG 0-2; c) measurable lesions 3. DLBCL with initial CR/PR according to 2016 WHO Classification of Tumor of Haematopoietic and Lymphoid Tissues 4. Life expectancy \> 3 months 5. Normal blood count as defined as: absolute neutrophil count ≥1.0 × 10 9 /L independent of growth factor support, platelet count ≥ 100,000/mm 3 or ≥ 50,000/mm 3 if bone marrow (BM) involvement independent of transfusion support in either situation Normal organ functions defined as: creatinine ≤1.5 times the upper limit of normal (ULN) or estimated Glomerular Filtration Rate (Cockroft-Gault) ≥50 ml/min/1.73m 2 , aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤2.5× the ULN; total bilirubin ≤ 1.5 × the ULN unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin: patients with documented Gilbert disease may be enrolled if total bilirubin is ≤ 3.0 × the ULN; 6. Women of childbearing potential and men who are sexually active must be practicing a highly effective method of birth control during and after the study consistent with local regulations regarding the use of birth control methods for subjects participating in clinical trials. - Women of childbearing potential must have a negative serum (beta-human chorionic gonadotropin \[Beta-hCG\]) or urine pregnancy test at Screening. Women who are pregnant or breastfeeding are ineligible for this study.
Exclusion criteria
1. Contraindication to any drug in the study 2. Seropositive for or active viral infection with HBV or HCV 3. Human immunodeficiency virus (HIV) infection 4. Any grade 3 or 4 heart disease as defined by the New York Heart Association (NYHA) functional class; 5. QTc (corrected by Fridericia formula): \>480ms; 6. Prior malignancies other than lymphoma in the last 5 years with exception of currently treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix 7. If female, the patient is pregnant or breast-feeding 8. Any uncontrolled active systemic infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year recurrence-free survival | 2 years after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | From enrollment to study completion, a maximum of 4.5 years | Overall survival was defined as the time from the date of enrollment to the date of death from any cause. |
| Overall response rate | up to 2 year, at the end of maintenance | ORR at treatment completion or discontinuation defined as the proportion of participants with partial response (PR) or CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC(separately) |
| Complete response rate | up to 2 year, at the end of maintenance | CR rate at the end of treatment by FDG-PET defined as the proportion of participants with CR at the end of treatment according to the 2014 Lugano Response Criteria; as determined by the investigator and IRC (separately) |
Contacts
Primary ContactWeili Zhao, M.D. and Ph.D
Outcome results
None listed