C-MYC positive diffuse large B-cell lymphoma
Conditions
Interventions
Sponsors
Kanagawa Clinical Oncology study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Histologically confirmed DLBCL, NOS according to the 2008 WHO classification (2) Confirmed CD20-positive (3) Confirmed C-MYC-positive by FISH (4) Tumor cell counts in the peripheral blood within 14 days before resistration are less than 10,000/mm3 (5) Age: 20 to 75 years old (6) PS (ECOG): 0-2 (7) No clinical symptoms of CNS involvement (8) Measureable lesion present (9) No prior chemotherapy, radiotherapy, and antibody therapy for DLBCL (10) Adequate organ function (11) Written informed consent
Exclusion criteria
Exclusion criteria: (1) History of glaucoma (2) Uncontrollable diabetes mellitus (3) Uncontrollable hypertension (4) Coronary artery disease under treatment; cardiomyopathy, heart failure, or arrhythmia treated with anti-arrhythmic (5) HBs antigen positive (6) HCV antibody positive (7) HIV antibody positive (8) Interstitial pneumonia, pulmonary fibrosis (9) Severe infection (10) Liver cirrhosis (11) Other active malignancies; history of lymphoma, myelodysplastic syndrome, or leukemia (12) Pregnant, possible pregnant, or breastfeeding woman (13) Severe psychosis (14) Under systemic corticosteroid therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression-free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate, Complete response rate, Overall survival, Toxicity | — |
Countries
Japan
Contacts
Public ContactMinoru Kojima, M.D., Ph.D.
Tokai University School of Medicine Division of Hematology/Oncology
Outcome results
None listed