Clinical research on sequential combination therapy with CHOP and mogamulizumab in patients with untreated primary adult T cell leukemia-lymphoma (FBMTG MOG16)
- Conditions
- Adult T-cell leukemia-lymphoma
- Registration Number
- JPRN-UMIN000022819
- Lead Sponsor
- Cooperative research with Fukuoka Blood & Marrow Transplant Group and CReS Kyushu
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Not provided
1) Patients with uncontrollable diabetes mellitus. 2) Patients with uncontrollable hypertension. 3) Patients with uncontrollable autoimmune disease. 4) Patients with severe skin disorder other than ATL lesion. 5) Patients with anamnesis of myocardial infarction and congestive heart failure, and complication of unstable angina. 6) Patients with less than 50% of resting ejection fraction in echocardiography and nuclear medical scan. 7) Patients with active double cancer. 8) Patients with uncontrollable active infection. 9) Patients with central nervous infiltration. 10) Patients with HIV antibody positive or HBs antigen positive. 11) Patients with complication of mental disease or psychiatric symptom. 12) Patients with pregnancy or possibility of pregnancy and patients with nursing. 13) Patients judged by the investigator to be inappropriate for study participation.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall Survival (OS)
- Secondary Outcome Measures
Name Time Method 1. Progression-free survival (PFS) at 1 year point after initial treatment 2. Overall survival (OS) at 1 year point after initial treatment 3. Overall response rate (ORR) 4. ORR according to lesion 5. Complete response rate 6. Evaluation of safety: occurrence of adverse events