An open-label, phase 2 study of brentuximab vedotin and Chemotherapy agents in the frontline treatment of subjects with peripheral T-cell lymphoma (PTCL)
- Conditions
- on-sALCL PTCL and CD30 expression <10%MedDRA version: 21.1Level: LLTClassification code 10034624Term: Peripheral T-cell lymphoma unspecified NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-002336-74-FR
- Lead Sponsor
- Seattle Genetics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 80
1.Age 18 years or older.
2.Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification.
3.The following non-sALCL PTCL subtypes are eligible:
a.PTCL – not otherwise specified (PTCL-NOS)
b.Angioimmunoblastic T-cell lymphoma (AITL)
c.Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1)
d.Enteropathy-associated T-cell lymphoma (EATL)
e.Hepatosplenic T-cell lymphoma
f.Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)
g.Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
h.Follicular T-cell lymphoma
i.Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype
4.CD30 expression <10% by local assessment
5.Fluorodeoxyglucose (FDG)-avid disease by PET and measurable disease of at least 1.5 cm by CT, as assessed by the site radiologist.
6.An Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2
Other protocol defined inclusion criteria may apply.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32
1.Current diagnosis of any of the following:
a.sALCL
b.Primary cutaneous T-cell lymphoproliferative disorders and lymphomas
c.Mycosis fungoides (MF), including transformed MF
2.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.
3.History of progressive multifocal leukoencephalopathy (PML).
4.Cerebral/meningeal disease related to the underlying malignancy.
5.Prior treatment with brentuximab vedotin.
Other protocol defined exclusion criteria may apply.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method