An open-label, phase 2 study of brentuximab vedotin and Chemotherapy agents in the frontline treatment of subjects with peripheral T-celllymphoma (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-IT
- Lead Sponsor
- SEAGEN INC.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- 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 or doxorubicin.
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 Main Objective: To evaluate the objective response rate (ORR) per blinded independent central review (BICR) using the Revised Response Criteria for Malignant<br>Lymphoma (Cheson 2007);Secondary Objective: - To evaluate the complete response (CR) following completion of study treatment (Cheson 2007)<br>- To evaluate progression-free survival (PFS) (Cheson 2007)<br>- To evaluate overall survival (OS)<br>- To evaluate duration of response (DOR) (Cheson 2007)<br>- To evaluate ORR per BICR using modified Lugano criteria (Cheson 2014)<br>- 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 Outcome Measures
Name Time Method Secondary end point(s): - Complete response rate per BICR (Cheson 2007)<br>- PFS per BICR (Cheson 2007)<br>- Overall survival (OS)<br>- Duration of response (DOR) per BICR<br>- ORR per BICR, using modified Lugano criteria (Cheson 2014)<br>- Type, incidence, severity, seriousness, and relatedness of adverse events<br>- Laboratory abnormalities;Timepoint(s) of evaluation of this end point: - 1 year after last subject enrolled<br>- 1 year after last subject enrolled<br>- 1 year after last subject enrolled<br>- 1 year after last subject enrolled<br>- 1 year after last subject enrolled<br>- 1 year after last subject enrolled