diffuse large B-cell lymphoma, including subtypes
Conditions
Interventions
A: biweekly RCHOP 6 courses followed by LEED with autologous peripheral blood stem cell transplantation
B: Biweekly RCHOP 3 courses and CHASER 3 courses followed by LEED with autologous peripheral blo
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed diffuse large B-cell lymphoma, including subtypes of T cell/histiocyte rich large B-cell lymphoma, primary cutaneous DLBCL leg type and EBV positive DLBCL of the elderly, lymphomatoid granulomatosis grade 3, and primary mediastinal (thymic) large B-cell lymphoma by the WHO classification 4th edition 2) Positive for CD20 in lymphoma cells by immunohistochemical or flowcytometric analysis 3) Aged 20 to 65 years old 4) Performance status (PS) of 0-2 on ECOG(Eastern Cooperative Oncology Group) scale 5) Stage III or IV disease, or stage II with bulky disease 6) High-intermediate or high risk group on AA-IPI (Age-adjusted International Prognostic Index) score 7) Lymphoma cells in peripheral blood <=10,000/mm3 within 14 days prior to registration 8) No testicular or central nervous system involvement 9) Having an measurable lesion 10) No previous history of chemotherapy, radiation therapy, interferon and/or antibody 11) Adequate hematological and major organ function 12) Written informed consent
Exclusion criteria
Exclusion criteria: 1) History of glaucoma 2) Diabetes mellitus regularly treated with insulin or uncontrollable diabetes mellitus 3) Uncontrollable hypertension 4) Serious cardiac conditions such as coronary disease, myocardiopathy and/or heart failure that requires treatment, and/or arrhythmia treated with antiarrhythmic 5) Positive test for HBs antigen 6) Positive test for HCV antibody 7) Positive test for HIV antibody 8) Interstitial pneumonia, pulmonary fibrosis or severe pulmonary emphysema 9) Other active malignancies 10) Severe infection that requires systemic therapy 11) Fever above 38 degrees Celsius except related to B symptoms 12) Pregnant, possible pregnant, or breastfeeding woman 13) Psychological disease or condition that precludes participation in clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 2-year progression free survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall response rate and complete response rate of both the entire treatment courses and the induction phases, 2-year and 5-year overall survival rate, 5-year progression free survival rate, adverse events, serious adverse events, and incidence rate of secondary malignancies | — |
Countries
Japan
Contacts
Public ContactKazuhito Yamamoto
JCOG0908 Coordinating Office Department of Hematology and Cell Therapy, Aichi Cancer Center
Outcome results
None listed