Relapsed or Refractory large B cell lymphoma
Conditions
Interventions
Case series:FKC876 treatment
Sponsors
Ruijin Hospital, School of Medicine, Shanghai Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed large B cell lymphoma, including the following types defined by WHO 2016: DLBCL not otherwise specified; DLBCL associated with chronic inflammation; Epstein-Barr virus (EBV)+DLBCL NOS; High-grade B cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements; High grade B cell lymphoma NOS;Primary mediastinal (thymic) large B cell lymphoma;Transformation of follicular lymphoma to DLBCL will also be included; 2. Chemoth erapy-refractory disease, defined as one or more of the following:No response to first-line therapy (primary refractory disease); subjects who are intolerant to first-line therapy chemotherapy are excluded;No response to second or greater lines of therapy; Refractory post-ASCT; 3. Subjects must have received adequate prior therapy including at a minimum:Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and An anthracycline containing chemotherapy regimen; For subjects with transformed FL must have received prior chemotherapy for follicular lymphoma and subsequently have chemorefractory disease after transformation to DLBCL; 4. At least 1 measurable lesion according to the revised IWG Response Criteria for Malignant Lymphoma (Lugano 2014). Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy; 5. MRI of the brain showing no evidence of CNS lymphoma; 6. Toxicities due to prior therapy must be stable and recovered to =Grade 1; 7. Adequate renal, hepatic, pulmonary and cardiac function defined as: Creatinine clearance (as estimated by Cockcroft Gault) =60mL/min; Serum ALT/AST =2.5ULN, total bilirubin =1.5mg/dl, except in subjects with Gilberts; Cardiac ejection fraction =50%, no evidence of pericardial effusion as determined by an ECHO, and no clinically significant ECG findings; No clinically significant pleural effusion; Baseline oxygen saturation >92% on room air; 8. Females of childbearing potential must have a negative serum or urine pregnancy test.
Exclusion criteria
Exclusion criteria: 1. History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) or follicular lymphoma unless disease free for at least 3 years; 2. History of allogeneic stem cell transplantation; 3. Prior chimeric antigen receptor therapy or other genetically modified T cell therapy; 4. Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; 5. History or presence of CNS disorder such as seizure disorder, cerebrovascular ischemia/ hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement; 6. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 7. Women of childbearing potential who are pregnant or breastfeeding; 8. History of autoimmune disease (e.g. Crohns, rheumatoid arthritis, systemic lupus) resulting in end organ injury or requiring systemic immunosuppression/ systemic disease modifying agents within the last 2 years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of dose limited toxicity;Overall response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Progression free survival;Duration of response;Overall survival; | — |
Countries
China
Contacts
Public ContactWeili Zhao
Ruijin Hospital, School of Medicine, Shanghai Jiaotong University
Outcome results
None listed