A phase III study comparing interferon-alpha and zidovudine with watchful waiting for indolent adult T-cell leukemia-lymphoma (JCOG1111C, IFN/AZT vs WW for indolent ATL P-III)
- Conditions
- Adult T-cell leukemia-lymphoma
- Registration Number
- JPRN-UMIN000011805
- 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
- 74
Not provided
1) Synchronous or metachronous malignancy 2) Active infection requiring systemic therapy 3) Body temperature >= 38 degrees Celsius 4) Pregnant or lactating women or women of childbearing potential 5) History of hypersensitivity to any of the components of the formulation in SumiferonTM 6) History of hypersensitivity to any of the components of the formulation in RetrovirTM 7) Prior allergic reactions to biological drugs including vaccines 8) Current treatment with Shosaiko-To 9) Current treatment with ibuprofen 10) Complication of autoimmune hepatitis 11) Psychiatric disease 12) Current treatment with systemic steroids 13) Poorly controlled diabetes mellitus or routine administration of insulin 14) Poorly controlled hypertension 15) Complication of unstable angina, cardiac infarction within 6 months, cardiomyopathy, cardiac failure, or arrhythmia requiring medical intervention 16) HBs-Ag positive 17) HCV-Ab positive 18) HIV-Ab positive 19) Complication of interstitial pneumonia, pulmonary fibrosis, or severe pulmonary emphysema
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Event-free survival
- Secondary Outcome Measures
Name Time Method Overall survival, acute transformation-free survival, other systemic treatment-free survival, additional treatment-free survival, and overall response rate, and dose intensity. Proportopn of adverse events, grade 4 non-hematological adverse events, early death, and treatment related death.