Phase II study of R-CODOX-M/R-IVAC therapy for the patients with newly diagnosed primary mediastinal large B-cell lymphoma
- Conditions
- Primary mediastinal large B-cell lymphoma
- Registration Number
- JPRN-UMIN000003793
- Lead Sponsor
- ational Cancer Center Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 35
Not provided
1) Uncontrollable hypertension. 2) History of myocardial infarction or angina or cardiomyopathy. 3) HBs antigen positive, HCV antibody positive or HIV antibody positive. 4) Accompanying interstitial pneumonitis, pulmonary fibrosis, or severe emphysema (all apparently diagnosed by chest X-ray). 5) Severe infections. 6) Liver cirrhosis, either biopsy proven or clinically diagnosed. 7) Active double cancer: overlapping cancer or asynchronous cancer within 5 years. Carcinoma in situ, intramucosal cancers, and other equivalent lesions are not included for the active double cancer. 8) Women during pregnancy, lactation period or of childbearing potentials not using a reliable contraceptive method. 9) Use of major tranquilizer, antidepressant or antimanic, or severe psychosis. 10) History of allogeneic or autologous hematopoietic stem cell transplantation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Complete response rate
- Secondary Outcome Measures
Name Time Method Progression-free survival, overall survival, incidence of adverse events, and utility of response criteria with FDG-PET/CT