Adult T-cell leukemia lymphoma
Conditions
Interventions
Mogamulizumab 1mg/kg, every 2 weeks (with CHOP-14) 6+2cycles CHOP (every 2 weeks) 6 cycles CPA 750mg/m2 div Day 1 DXR 50mg/m2 div Day 1 VCR 1.4mg/m2 (max 2.0mg) iv Day 1 PSL 40mg/m2 po Day 1,
Sponsors
KAGOSHIMA UNIVERSITY Graduate School of Medical and Dental Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Those who meet all of the following are eligible. 1) Cytologically or pathologically proven peripheral T-cell malignancy with positivity for anti-HTLV-1 antibody. 2) ATL in acute type, lymphoma type, or chronic type with unfavorable prognostic factors. 3) Positive for CCR4 antigen by flow cytometry or immunehistochemistry. 4) Aged over 66 years old or between 56 and 65years old if the patients do not want to receive allogeneic stem cell transplantation. 5) ECOG PS 0-3, or PS 4 with hypercalcemia. 6) No previous anti-cancer treatment, except for interferon and antiretroviral treatment. Steroids should be discontinuation until registration. 7) Meet all of the following i) neutrophil=>1,500/mm3 (neu=>500/mm3 with bone marrow involvement) ii) Platelet=>10.0x104/mm3 (PLT 2.0x104/mm3 with bone marrow involvement) iii) GOT(AST)=>150 U/L (GOT(AST)=<300 U/L with Liver involvement) iv) male : GPT(ALT)=<210 U/L female : GPT(ALT)=<115 U/L (male : GPT(ALT)=<420 U/L, female : GPT(ALT)=<230 U/L with liver involvemnet) v) T.Bil=<2.0mg/dL (T.Bil=<5.0mg/dL with liver involvement) vi) serum creatinine=<1.6mg/dL(male), 1.2mg/dL (female) vii) SpO2=>92% (room air) (SpO2=>90% (room air) with lung involvement) viii) Normal ECG ix) Ejection fraction=>50% by UCG 8) Written informed consent.
Exclusion criteria
Exclusion criteria: 1) CNS disease 2) Complication of coronary disease, cardiomyopathy, cardiac failure, or arrhythmia requiring medical intervention. 3) Diabetes mellitus uncontrolled by administration of insulin 4) HBs-Ag positive 5) HCV-Ab positive 6) HIV-Ab positive 7) Liver cirrhosis 8) Complication of interstitial pneumonia or pulmonary fibrosis requiring oxygen administration 9) Synchronous or metachronous malignancy 10) Autoimmune disease 11) Pregnant or lactating women 12) Psychiatric disease 13) History of hypersensitivity to any of the components of the formulation in POTELIGEO. 14) Patients who are considered to be unsuitable for enrollment by the physician.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year progression free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| complete response rate response rate overall survival 1 year event free survival adverse events | — |
Countries
Japan
Contacts
Public ContactIlseung Choi
National Hospital Organization Kyushu Cancer Center Department of Hematology
Outcome results
None listed