Refractory Diffuse Large B-cell Lymphoma
Conditions
Interventions
Case group:Nil
Sponsors
The Affiliated Hospital of Qingdao University
Eligibility
Sex/Gender
All
Age
16 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with refractory diffuse large B-cell lymphoma (DLBCL) confirmed histopathologically/cytologically according to the 2016 World Health Organization (WHO) Classification of disease, And subjects cannot tolerate or are unwilling to undergo intensive chemotherapy; Prior treatment was at most two-line, in which stem cell transplantation was considered the first line. 2. Age 16-70; 3. Expected survival time > 3 months; 4. ECOG = 90 g/L; (2) the ANC > = 1.5 x 109 / L; (3) the PLT > = 75 x 109 / L; Biochemical examination: (1)TBIL = 50mL/min (Cockcroft-Gault formula) coagulation function (unless subjects are receiving anticoagulant therapy and coagulation parameters (PT/INR and APTT) are within the expected range of anticoagulant therapy at screening time) : 1) International standardized ratio (INR) 15mm or extranodal lesions > 10mm) and FDG-PET positive lesions] 7. The woman is not breastfeeding, is not pregnant and agrees not to be pregnant during the study period and for the following 12 months. Male patients agreed that their spouse would not become pregnant during the study period and for 12 months thereafter; 8. Sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Diagnosed as double hit or treble hit DLBCL or high-grade B-cell lymphoma(HGBL-NOS). 2. Serious systemic infections or local infections during the 2 months before screening. 3. patients diagnosed as CNS lymphoma, testicular or mammary DLBCL. 4. Any prior exposure to 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 the 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free time;Overall survival time;Safety; | — |
Countries
China
Contacts
Public ContactXue Hongwei
The Affiliated Hospital of Qingdao University
Outcome results
None listed