A multicenter phase II study for previouly untreated advanced stage peripheral T-cell lymphoma evaluating efficacy and safety of combination chemotherapy with THP-COP regime
- Conditions
- previouly untreated advanced stage peripheral T-cell lymphoma
- Registration Number
- JPRN-UMIN000014902
- Lead Sponsor
- Hematological Malignancy Study Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 40
Not provided
1.Presence of central nervous involvement (clinical or pathological) 2.Diabetes mellitus receiving insulin therapy 3.Uncontrollable hypertension 4.History of angina pectoris or myocardial infarction. Comorbidity of cardiomyopathy. Arrhythmia on treatment with antiarrhythmic agents 5.Positive test for HBs antigen 6.Positive test for HCV antibody 7.Positive test for HIV antibody 8.Accompanying interstitial pneumonitis, pulmonary fibrosis or severe emphysema diagnosed by chest X-ray 9.Severe infection 10. Biopsy proven or clinically diagnosed Liver cirrhosis 11. 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 12. Use of major tranquilizer, antidepressant or antimanic drugs 13. Severe psychosis
Study & Design
- Study Type
- Interventional,observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method complete response rate, %CR
- Secondary Outcome Measures
Name Time Method 1) short-term safety 2) response rate (%RR) 3) 1year progression-free survival (1-y PFS) 4) 1year overall survival (1-y OS) 5)long-term safety