Brentuximab Vedotin for the Treatment of CD30 Positive T-Cell Lymphomas in Patients after Stem Cell Transplant, BRENTICON-T Study

Inclusion Criteria

• Ability of participant OR legally authorized representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
• Males and females age >= 18 years
• Prior therapy: Six (6) cycles of anthracycline‐based chemotherapy with or without brentuximab vedotin.
• Eastern Cooperative Oncology Group (ECOG) performance status = 0-2
• Patients with CD30-expressive mature T-cell lymphomas per the Revised European-American Lymphoma World Health Organization (WHO) 2008 classification by local assessment who have received 6 cycles of anthracycline‐based chemotherapy as induction and achieved complete remission (CR) or chemo-sensitive partial remission (PR) and deemed suitable for ASCT as consolidation
• N.B: CD30 expression > or equal to 1% lymphoid infiltrate
• Eligible histologies are limited to the following: * ALK-negative systemic anaplastic large cell lymphoma (sALCL) * Peripheral T-cell lymphoma – not otherwise specified (PTCL-NOS) * Angioimmunoblastic T-cell lymphoma (AITL) * Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T-cell leukemia virus 1) * Enteropathy-associated T-cell lymphoma (EATL) * Hepatosplenic T-cell lymphoma *ALK‐positive sALCL with International Prognostic Index (IPI) of 4 or 5
• Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease by computed tomography (CT), as assessed by the site radiologist
• Leukocytes >= 1.5 K/UL
• Absolute neutrophil count >= 1.0 K/UL
• Platelets >= 50 K/UL
• Serum creatinine clearance > 40 mL/min
• Total bilirubin =< 1.5 x ULN
• Aspartate aminotransferase and alanine aminotransferase =< 2.5 x upper limit of normal (ULN)
• Women of child-bearing potential and men with partners of child-bearing potential must agree to practice sexual abstinence, or to use the forms of contraception for the duration of study participation, and for 6 months following completion of therapy

Exclusion Criteria

• Simultaneously enrolled in any therapeutic clinical trial
• Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
• Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
• Is breastfeeding
• Has a known allergic reactions to any excipient contained in the study drug formulation
• Active grade 3 (per the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment
• Has human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection
• Left ventricular ejection fraction (LVEF) less than 45% or symptomatic cardiac disease (including symptomatic ventricular dysfunction, symptomatic coronary artery disease, and symptomatic arrhythmias), or myocardial infarction within the past 6 months
• Previous treatment with complete cumulative doses of doxorubicin or other anthracyclines
• Baseline peripheral neuropathy > grade 2 (per the NCI CTCAE, version 5.0) or patients with the demyelinating form of Charcot-Marie-Tooth syndrome
• Post allo stem cell transplant (SCT)
• Resistant or progressive disease on anthracycline‐based induction chemotherapy
• Cerebral/meningeal disease related to the underlying malignancy
• History of progressive multifocal leukoencephalopathy (PML)
• Current diagnosis of any of the following: * Primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas. Cutaneous ALCL with extracutaneous tumor spread beyond locoregional lymph nodes is eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible) * Mycosis fungoides (MF), including transformed MF * ALK positive systemic ALCL with IPI of 3 or less