An investigator-initiated, multicenter, phase II study to determine the efficacy and safety of brentuximab vedotin in patients with relapsed or refractory CD30-positive cutaneous T-Cell lymphoma

Not Applicable

• Conditions: Cohort 1: Subjects with CD30+ mycosis fungoides or pcALCL Cohort 2: Subjects with other (non-Cohort 1) CD30+ cutaneous T-Cell lymphomas

• Registration Number: JPRN-UMIN000034205
• Lead Sponsor: Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-01
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified