relapsed and refractory diffuse large B-cell lymphoma
Conditions
Interventions
Treatment group:Lenalidomide, PD1 and BTK inhibitor / rituximab
Sponsors
Yancheng NO1.People's Hospital
Eligibility
Sex/Gender
All
Age
12 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Relapsed and refractory DLBCL: (1) Previously treated with at least 1 chemotherapy regiments; (2) The interval between the last chemotherapy and disease progression was less than 1 year; (3) Not suitable for hematopoietic stem cell transplantation or give up hematopoietic stem cell transplantation due to limited conditions; 2. Age >= 12 years, and age = 6 months; 4. Eastern Cooperative Oncology Group performance status score= 1.0×10^9/L, Platelet (PLT)>= 50×10^9/L; Hb >= 7.0 g/dL; (2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 50 mL/min (estimated by Cockcroft-Gault formula); (4) Coagulation function: International standardized ratio (INR) <= 1.5×ULN; Activated partial thrombin time (APTT) <= ULN (10 s); (5) Thyroid stimulating hormone (TSH) is in the normal range; If TSH is abnormal, free triiodothyrosine (FT3) and free thyroxine (FT4) should be in the normal range, and thyroid peroxidase antibody (TPOAb), thyroglobulin antibody (TgAb) and thyroid stimulating hormone receptor antibody (TRAb) should be negative; 6. Women of childbearing age shall have a negative urine pregnancy test prior to the beginning of dosing, and fertile subjects (male or female) shall use effective medical contraception during the study period and for 6 months after dosing; 7. Provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Infected with hepatitis B (HBV) and hepatitis C (HCV) (HBV infection means HBsAg positive, or HBV-DNA detectable) and other acquired congenital immune deficiency diseases, including but not limited to HIV-infected persons; 3. Abnormal liver and kidney function, direct bilirubin, serum indirect bilirubin and / or alanine aminotransferase, glutamic-oxaloacetic transaminase, serum creatinine > 2×ULN, creatinine clearance < 60 mL/min, unless abnormal liver or kidney function is identified as associated with lymphoma; 4. Patients with a history of deep vein thrombosis (DVT) or pulmonary embolism (PE) in the past 12 months; 5. Bone marrow failure, defined as absolute neutrophil count (ANC) < 1.5×10^9/L or platelets < 75×10^9/L, unless hematologic changes are considered to be associated with lymphoma infiltrating bone marrow; 6. Patients with significant heart disease, including unstable angina, Acute myocardial infarction, congestive heart failure (NYHA), cardiac function was graded as grade III or IV in past 6 months; Or left ventricular ejection fraction < 50%; 7. Hypersensitivity is known to the test drugs; 8. Patients with grade 3 or more neurotoxic reactions within two weeks prior to treatment; 9. Patient with severe infection; 10. Patients who was considered unsuitable for participation in this trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete response;Progression Free Survival;Duration of remission;Time to response;Safety; | — |
Countries
China
Contacts
Public ContactYuqing Miao
Yancheng NO1.People's Hospital
Outcome results
None listed