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NCT04569032

PHASE2

A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

View on ClinicalTrials.gov

Summary

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2020-11-12

Completion Date

2026-01-12

Last Updated

2026-08-13

Healthy Volunteers

Conditions

Peripheral T-cell Lymphoma

Interventions

DRUG

brentuximab vedotin

1.8 mg/kg administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

DRUG

cyclophosphamide

750 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

DRUG

doxorubicin

50 mg/m\^2 administered intravenously (IV; into the vein) on Day 1 of each 21 -day cycle

DRUG

prednisone

100 mg daily administered orally on Days 1-5 of each cycle

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.

Locations (63)

University of Alabama at Birmingham

Birmingham, Alabama, United States

University of Alabama at Birmingham

Birmingham, Alabama, United States

Stanford Cancer Center

Stanford, California, United States

Stanford Hospital and Clinics, Investigational Drug Services

Stanford, California, United States