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

Completed · Phase 2

Conditions studied: Peripheral T-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT04569032

Run by

Seagen, a wholly owned subsidiary of Pfizer

People needed

82

Starts

2020-11-12

Expected to finish

2026-01-12

Last updated by the study team

2026-02-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• 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
• Rocky Mountain Cancer centers, LLP — Aurora, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Boulder, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Colorado Springs, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Denver, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Denver, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Lakewood, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Littleton, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Lone Tree, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Longmont, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Pueblo, Colorado, United States
• Rocky Mountain Cancer centers, LLP — Thornton, Colorado, United States
• Tulane Cancer Center — New Orleans, Louisiana, United States
• Tulane Medical Center — New Orleans, Louisiana, United States
• Memorial Sloan Kettering Cancer Center David H. Koch Center for Cancer Care — New York, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, United States
• Cleveland Clinic taussig Cancer Center Investigational Pharmacy — Cleveland, Ohio, United States
• Cleveland Clinic, The — Cleveland, Ohio, United States
• Texas Oncology - Central/South Texas — Austin, Texas, United States
• Texas Oncology - Central South (Balcones Dr) — Austin, Texas, United States
• Texas Oncology - Central South (James Casey) — Austin, Texas, United States
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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