Randomized phase II study of biweekly R-CHOP versus biweekly R-CHOP followed by CHASER as induction therapy for high-dose chemotherapy, LEED, and autologous stem-cell transplantation in poor-risk diffuse large B-cell lymphoma (JCOG0908, DLBCL-bi-R-CHOP/CHASER-LEED-rP2 )
- Conditions
- diffuse large B-cell lymphoma, including subtypeslymphomatoid granulomatosis, grade 3primary mediastinal (thymic) large B-cell lymphoma
- Registration Number
- JPRN-UMIN000003823
- Lead Sponsor
- Japan Clinical Oncology Group (JCOG)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 70
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 2-year progression free survival rate
- Secondary Outcome Measures
Name Time Method 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