Description:
This study will look at whether brentuximab vedotin works and is safe in the re-treatment
setting. To be in this study, patients must have already received brentuximab vedotin as
treatment and have cancer that progressed (got worse) after stopping treatment.
Title
- Brief Title: A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma
- Official Title: A Phase 2, Multicenter, Single-arm Study of Retreatment With Brentuximab Vedotin in Subjects With Relapsed or Refractory Classic Hodgkin Lymphoma (cHL) or CD30-expressing Peripheral T Cell Lymphoma (PTCL)
Clinical Trial IDs
- ORG STUDY ID:
SGN35-028
- NCT ID:
NCT03947255
Conditions
- Hodgkin Lymphoma
- Peripheral T Cell Lymphoma
- Anaplastic Large Cell Lymphoma
Interventions
Drug | Synonyms | Arms |
---|
brentuximab vedotin | ADCETRIS, SGN-35 | Brentuximab vedotin |
Purpose
This study will look at whether brentuximab vedotin works and is safe in the re-treatment
setting. To be in this study, patients must have already received brentuximab vedotin as
treatment and have cancer that progressed (got worse) after stopping treatment.
Detailed Description
This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with
classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other
CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or
partial response (PR) with a brentuximab vedotin-containing regimen and subsequently
experienced disease progression or relapse.
Trial Arms
Name | Type | Description | Interventions |
---|
Brentuximab vedotin | Experimental | | |
Eligibility Criteria
Inclusion Criteria:
- Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL
- Previously treated with brentuximab vedotin containing regimen, with evidence of
objective response, and subsequent disease progression or relapse after discontinuing
treatment
- Documentation of disease relapse or progression ≥6 months after the last dose of
brentuximab vedotin
- Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional
measurable disease of at least 1.5 cm in longest axis as documented by radiographic
technique
- Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to
2
- Must not be pregnant and, if of childbearing or fathering potential, must agree to use
2 effective contraception methods during study and for 6 months following last dose of
study drug
Exclusion Criteria:
- Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity
- Existing Grade 2 or higher peripheral neuropathy
- Previously refractory to treatment with brentuximab vedotin
- History of a cerebral vascular event, unstable angina, or myocardial infarction within
6 months prior to first dose
- History of another malignancy within 3 years before first dose of study drug or any
evidence of residual disease from previously diagnosed malignancy
- Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive
therapy as treatment for or prophylaxis agent against GvHD
- Active cerebral/meningeal disease
- History of progressive multifocal leukoencephalopathy (PML)
- Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal
infection within 2 weeks prior to first dose of study drug
- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with
immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless
underlying disease has progressed on treatment
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Objective response rate (ORR) per BICR according to modified Lugano response criteria (Cheson 2014) |
Time Frame: | Up to approximately 1 year |
Safety Issue: | |
Description: | |
Secondary Outcome Measures
Measure: | Duration of response (DOR) per BICR according to modified Lugano response criteria (Cheson 2014) |
Time Frame: | Up to approximately 5 years |
Safety Issue: | |
Description: | |
Measure: | Progression-free survival (PFS) per BICR according to modified Lugano response criteria (Cheson 2014) |
Time Frame: | Up to approximately 5 years |
Safety Issue: | |
Description: | |
Measure: | Overall survival (OS) |
Time Frame: | Up to approximately 5 years |
Safety Issue: | |
Description: | |
Measure: | Rate of complete response (CR) per BICR according to modified Lugano response criteria |
Time Frame: | Up to approximately 1 year |
Safety Issue: | |
Description: | |
Measure: | ORR per investigator assessment according to modified Lugano response criteria (Cheson 2014) |
Time Frame: | Up to approximately 1 year |
Safety Issue: | |
Description: | |
Measure: | DOR per investigator assessment according to modified Lugano response criteria (Cheson 2014) |
Time Frame: | Up to approximately 5 years |
Safety Issue: | |
Description: | |
Measure: | PFS per investigator assessment according to modified Lugano response criteria (Cheson 2014) |
Time Frame: | Up to approximately 5 years |
Safety Issue: | |
Description: | |
Measure: | Rate of CR per investigator assessment according to modified Lugano response criteria (Cheson 2014) |
Time Frame: | Up to approximately 5 years |
Safety Issue: | |
Description: | |
Measure: | ORR per BICR according to Lugano response criteria (Cheson 2014) |
Time Frame: | Up to approximately 1 year |
Safety Issue: | |
Description: | |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Recruiting |
Lead Sponsor: | Seagen Inc. |
Trial Keywords
- CD30-expression
- sALCL
- PTCL
- cHL
- Seattle Genetics
Last Updated
August 3, 2021