Phase
Condition
T-cell Lymphoma
Lymphoma
Lymphoproliferative Disorders
Treatment
Brentuximab vedotin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histologically- confirmed cluster of differentiation antigen 30 positive (CD30+)disease by local laboratory assessment and pathology review.
Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) who havereceived prior radiation therapy or at least 1 prior systemic therapy, orparticipants with mycosis fungoides (MF) who have received at least 1 prior systemictherapy for their disease. 3. Eastern Cooperative Oncology Group (ECOG) performancestatus of ≤2. 4. Suitable venous access for the study-required blood sampling. 5.Participants must have radiographically or clinically measurable or evaluabledisease.
Recovered (i.e., Grade 1 toxicity) from the reversible effects of priorantineoplastic therapy.
Exclusion
-Exclusion Criteria:
A concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL), or othernon-Hodgkin lymphoma (excluding lymphomatoid papulosis [LyP]).
A concurrent diagnosis of sézary syndrome (SS) or high blood tumor burden (B2)disease.
Corticosteroid therapy for the treatment of cutaneous T-cell lymphoma (CTCL) within 3 weeks of first dose of study drug.
Known hypersensitivity to recombinant proteins, murine proteins, or any excipientcontained in the drug formulation.
Life-threatening illness unrelated to cancer.
Severe central nervous system (CNS), pulmonary, renal, or hepatic disease notrelated to the participant's cancer.
Known active cerebral/meningeal disease, including signs or symptoms of progressivemultifocal leukoencephalopathy (PML).
Known human immunodeficiency virus (HIV) positive.
Known hepatitis B surface antigen positive or known or suspected active hepatitis Cinfection.
Any severe active systemic viral, bacterial, or fungal infection within 1 weekbefore first study drug dose requiring systemic antimicrobial therapy. (Oralantibiotics for prophylaxis are allowed.)
Receiving antibody-directed or immunoglobulin-based immune therapy (eg,immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks offirst study drug dose.
Any of the following cardiovascular conditions or values within 6 months before thefirst dose of study drug:
Myocardial infarction within 6 months of enrollment.
New York Heart Association (NYHA) Class III or IV heart failure.
Evidence of current uncontrolled cardiovascular conditions, including cardiacarrhythmias, congestive heart failure (CHF), angina, or electrocardiographicevidence of acute ischemia or active conduction system abnormalities.
History of another primary malignancy not in remission for at least 3 years. Thefollowing are exempt from the 3-year limit: completely resected in situ carcinoma,such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or asquamous intraepithelial lesion on Pap smear.
Oral retinoid therapy for any indication within 3 weeks of the first dose of studydrug.
History of pancreatitis or significant risk factors for developing pancreatitis (eg,prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption,uncontrolled diabetes mellitus, biliary tract disease, and medications known toincrease triglyceride levels or to be associated with pancreatic toxicity).
Study Design
Study Description
Connect with a study center
Peking University First Hospital
Beijing, Beijing 100034
ChinaSite Not Available
Peking University Third Hospital
Beijing, Beijing 100191
ChinaSite Not Available
Huashan Hospital, Fudan University
Shanghai, Shanghai 200040
ChinaSite Not Available
West China Hospital, Sichuan University
Chengdu, Sichuan 610041
ChinaSite Not Available
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