Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:55 PM
Ignite Modification Date:
2025-12-24 @ 9:55 PM
NCT ID:
NCT04569032
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04569032
Study Brief:
Protocol Section:
NCT04569032