A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
Trial Status: Active
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.
- 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
- Current diagnosis of any of the following:
- 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.
University of Alabama at Birmingham Cancer Center
Contact: Gaurav Goyal
Memorial Sloan Kettering Cancer Center
Contact: Steven Michael Horwitz
Case Comprehensive Cancer Center
M D Anderson Cancer Center
Virginia Commonwealth University / Massey Cancer Center
Trial Phase Phase II
Trial Type Treatment
- Primary ID SGN35-032
- Secondary IDs NCI-2020-09904
- Clinicaltrials.gov ID NCT04569032