Adult T-cell Leukemia/Lymphoma (ATL)
Conditions
Interventions
Phase 1 portion
Mogamulizumab plus lenalidomide induction: 1 mg/m2 of mogamulizumab 8 times bi-weekly (fixed dose and schedule) with 5 to 25 mg/day of oral lenalidomide. Phase 2 portion
Induction by mogamulizumab and lenalidomide
1 mg/m2 of mogamulizumab 8 times bi-weekly with recommended dose of oral lenalidomide determined in P1 portion. Lenalidomide maintenance Final dose of oral lenalidomide at the end of induction ph
Sponsors
Nonprofit Organization, Clinical Hematology Oncology Treatment Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Phase 1 portion; 1)Hematocytologically or pathohistologically proven peripheral lymphoid malignancy with T cell phenotype with positivity of anti-HTLV-1 antibody 2)Aggressive subtypes (acute, lymphoma type, or chronic type with unfavorable factor) at initial treatment 3)Positivity for CCR4 by flow cytometry or immunohistochemistry 4)Relapsed or refractory ATL after one or more prior lines of chemotherapy 5)Aged 20 or older 6)Having at least one of a measurable lesion, or an evaluable lesion in either of peripheral blood or skin 7)Women who can possibly become pregnant must agree to undergo a pregnancy test, and use birth control methods from 28 days of the first day of protocol treatment, to 28 days from the last dose of the study drug 8)Male must agree to the use of contraceptions during the protocol treatment, and for 28 days from the last dose of the study drug 9)Able to comply RevMate 10)ECOG performance status 0-3, however PS4 due to hypercalcemia is permissible 11)Adequate organ functions (1)Neutorphil more than 1,200/mm3 (2)Platelet more than 7.5x104/mm3 (3)GOT(AST) less than 150U/L (4)Male:GPT(ALT) less than 210U/L, Female:GPT(ALT) less than 115U/L (5)Total Bilirubin less than 2.25mg/dL (6)Creatinine clearance(CLCr) more than 60mL/min (7)SpO2 more than 92%(room air) (8)No ischemic change, atrial fibrillation, ventricular arrhythmias requiring treatment, in ECG (9)Left ventricular ejection fraction more than 50% with echocardiography 12)Written informed consent from the patient 13)Expected more than 3 months of survival Phase 2 portion; 1)Fulfill the inclusion criteria of phase I, except for specified below 2)CLCr more than 30mL/min 3)Criteria is modified in case of affected by ATL infiltration (1)Neutorphil; more than 750/mm3 in case of bone marrow involvement (2)Platelet; more than 5.0x104/mm3 in case of bone marrow involvement (3)Total Bilirubin; less than 4.5mg/dL in case of liver involvement (4)SpO2; more than 90% in case of pulmonary involvement
Exclusion criteria
Exclusion criteria: 1)Complication of central nervous invasion 2)Unstable angina, myocardial infarction, cardiomyopathy, heart failure, or arrythmia needed treatment 3)Poorly controlled hypertension 4)Diabetes mellitus poorly controlled and regularly treated by insulin. 5)HBs-Ag positive, or HBs-Ab and/or HBc-Ab positive with HBV-DNA positive 6)HCV-Ab positive 7)HIV-Ab positive 8)Complication or history of liver chirrosis 9)Complication or history of interstitial pneumonia or pulmonary fibrosis diagnosed by image and/or symptoms, requirement of oxygen administration 10)Synchronous or metachronous malignancy except carcinoma in situ or cancer confined to the mucosa and curatively treated by local resection 11)Complication or history of autoimmune diseases 12)Complication of grade 3 peripheral neuropathy 13)High risk of thrombosis, and not accept for the prevention of venous thrombosis 14)Active infection requiring systemic treatment 15)Pregnant or nursing women 16)Psychological disturbance 17)Hypersensitivity for the component of mogamulizumab 18)History of allogeneic stem cell transplantation (SCT) 19)History of organ transplant 20)History of chemotherapy or radiotherapy for malignancy other than ATL 21)Less than 12 weeks interval form autologous SCT to the scheduled first day of protocol treatment 22)History of sever adverse events (AEs) with thalidomide 23)History of dermatological AEs more than grade 3, or continuous administration of systemic adrenocorticoids for the dermatological adverse events, by mogamulizumab or lenalidomide 24)Less than 4 weeks interval form the last administration of other investigational drugs to the scheduled first day of protocol treatment 25)Less than 2 weeks interval form the last administration of mogamulizumab or lenalidomide to the scheduled first day of protocol treatment 26)Less than 2 weeks interval form the last chemotherapy for ATL to the scheduled first day of protocol treatment 27)Other inadequate conditions determined by investigators
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| P1 portion; determining the recommended dose to combine lenalidomide with mogamulizumab P2 portion; response rate (best overall response) | — |
Secondary
| Measure | Time frame |
|---|---|
| P1 portion; toxicity, response rate P2 portion; complete response rate, overall survival, progression free survival, toxicity, response rate according to prior therapies | — |
Countries
Japan
Contacts
Public ContactYoshitaka Imaizumi, M.D., Ph.D.
Nagasaki University Hospital Department of Hematology
Outcome results
None listed