A Dual-cohort, Open-label, Phase 2 Study of Brentuximab Vedotin and CHP (A+CHP) in the Frontline Treatment of Subjects With Peripheral T-cell Lymphoma (PTCL) With Less Than 10% CD30 Expression

SGN35-032

This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

2020-11-12

2024-09-30

2024-09-30

Active (not recruiting)

Early phase I

82

Inclusion Criteria * Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification * The following non-sALCL PTCL subtypes are eligible: * PTCL - 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 * Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL) * Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract * Follicular T-cell lymphoma * Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype * CD30 expression \<10% by local assessment in tumor containing lymph node or other extranodal soft tissue biopsy * Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist * An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Exclusion Criteria * Current diagnosis of any of the following: * sALCL * Primary cutaneous T-cell lymphoproliferative disorders and lymphomas * Mycosis fungoides (MF), including transformed MF * History of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least 3 years. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), such as carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer. * History of progressive multifocal leukoencephalopathy (PML). * Cerebral/meningeal disease related to the underlying malignancy. * Prior treatment with brentuximab vedotin or doxorubicin. * Baseline peripheral neuropathy Grade 2 or higher (per the NCI CTCAE, Version 4.03) or subjects with the demyelinating form of Charcot-Marie-Tooth syndrome. * Left ventricular ejection fraction 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, or previous treatment with complete cumulative dose of \>300 mg/m2 of doxorubicin. * Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted.

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2024-02-20