Cohort 1: Subjects with CD30+ mycosis fungoides or pcALCL Cohort 2: Subjects with other (non-Cohort 1) CD30+ cutaneous T-Cell lymphomas
Conditions
Interventions
The study drug will be administered by intravenous infusion over approximately 30 minutes on Day 1 of each 3 week cycle of treatment. In the absence of infusion-related reactions, the infusion rate
Sponsors
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients who provided written voluntary informed consent using the informed consent form approved by the institutional review board or equivalent. 2.Male or female patients aged 20 years or older at the time of consent 3.Patients with histologically confirmed CD30 positive cutaneous T Cell lymphomas by local histopathological assessment. 4.Patients with MF who have received at least one cycle of prior systemic therapy with inadequate response, or patients with pcALCL who have received prior radiotherapy or systemic therapy with inadequate response 5.Patients with an Eastern Cooperative Oncology Group Performance Status score of less than 2 6.Patients in whom all clinically important adverse effects of prior systemic therapy have resolved or improved in severity to grade less than 1 according to the National Cancer Institute Common Terminology Criteria for Adverse Events v4.0 7.Patients with laboratory data at screening meeting the following criteria: a.Absolute neutrophil count over 1,500/mcL b.Platelet count over 75,000/mcL c.Bilirubin less than 1.5 times the upper limit of normal d.Aspartate aminotransferase and alanine aminotransferase less than 3 times ULN AST and ALT may be elevated up to 5 times the ULN if the elevation was determined to be due to hepatic involvement of the disease. e.Creatinine clearance or calculated creatinine clearance over 40 mL/min f.Hemoglobin must be over 8g/dL 8.Patients who agree to use appropriate contraception methods from the time of screening through the end of the study. 9.Patients who received antibody therapy, immunoglobulin-based immune therapy, or other monoclonal antibody therapies must have a 12-week washout interval between the time of informed consent and the start of study drug administration. However, the washout interval may be shortened to 3 weeks if judged to be appropriate by the investigator or subinvestigator.
Exclusion criteria
Exclusion criteria: 1.Patients with concurrent systemic ALCL 2.Patients with concurrent Sezary syndrome or B2 disease 3.Patients with any of the following cardiovascular conditions or test values within 6 months before enrollment a.Myocardial infarction. b.New York Heart Association Class 3 or 4 heart failure c.Any uncontrolled cardiovascular conditions 4.Patients with a history of another primary malignancy not in remission for at least 3 years. 5.Patients with known active cerebral meningeal disease, including signs or symptoms of progressive multifocal leukoencephalopathy 6.Patients with known HIV infection 7.Patients with known hepatitis B surface antigen positivity or known or suspected active hepatitis C infection 8.Patients with any severe active systemic viral, bacterial, or fungal infection requiring systemic treatment before the start of study drug administration. 9.Patients who received antibody directed or immunoglobulin based immune therapy within 12 weeks before study drug administration 10.Patients who received corticosteroid therapy for the treatment of CTCL within 3 weeks before study drug administration 11.Patients with known hypersensitivity to recombinant proteins, murine proteins, or any excipient contained in the drug formulation 12.Female patients who are pregnant or breastfeeding, or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle 13.Patients who received treatment with radiotherapy, other skin directed therapy, or any investigational drug within 3 weeks before study drug administration 14.Patients with pancreatitis or significant risk factors for developing pancreatitis 15.Patients who previously received brentuximab vedotin before this study 16.Other patients judged by the investigator or subinvestigator to be inappropriate for participation in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving objective response lasting at least 4 months(ORR4) (per independent review facility [IRF] assessment) | — |
Countries
Japan
Contacts
Public ContactShiho Yoshida
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Center for Innovative Clinical Medicine
Outcome results
None listed