Non-sALCL PTCL and CD30 expression <10% MedDRA version: 21.1 Level: LLT Classification code 10034624 Term: Peripheral T-cell lymphoma unspecified NOS System Organ Class: 100000004864
Conditions
Interventions
Trade Name: ADCETRIS®
Product Name: Brentuximab vedotin
Product Code: SGN-35
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: BRENTUXIMAB VEDOTIN
CAS Number:
Sponsors
Seattle Genetics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range 32
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the objective response rate (ORR) per blinded independent central review (BICR) using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007);Secondary Objective: ? To evaluate the complete response (CR) following completion of study treatment (Cheson 2007) ? To evaluate progression-free survival (PFS) (Cheson 2007) ? To evaluate overall survival (OS) ? To evaluate duration of response (DOR) (Cheson 2007) ? To evaluate ORR per BICR using modified Lugano criteria (Cheson 2014) ? To evaluate safety and tolerability;Primary end point(s): ORR per BICR following the completion of study treatment using Revised Response Criteria for Malignant Lymphoma criteria (Cheson 2007);Timepoint(s) of evaluation of this end point: 6 months after last subject enrolled | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Complete response rate per BICR (Cheson 2007) ? PFS per BICR (Cheson 2007) ? Overall survival (OS) ? Duration of response (DOR) per BICR ? ORR per BICR, using modified Lugano criteria (Cheson 2014) ? Type, incidence, severity, seriousness, and relatedness of adverse events ? Laboratory abnormalities;Timepoint(s) of evaluation of this end point: ? 1 year after last subject enrolled ? 1 year after last subject enrolled ? 1 year after last subject enrolled ? 1 year after last subject enrolled ? 1 year after last subject enrolled ? 1 year after last subject enrolled | — |
Countries
Czech Republic, France, Italy, Spain, United Kingdom, United States
Contacts
Public ContactSeagen Clinical Trial Information
Seattle Genetics, Inc.
Outcome results
None listed