A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

Conditions
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Hodgkin Lymphoma, Peripheral T Cell Lymphoma, Anaplastic Large Cell Lymphoma

Intervention / Treatment
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* Drug: brentuximab vedotin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brentuximab vedotin<br> | Drug: brentuximab vedotin<br>* 1.8 mg/kg given intravenously (IV)<br>* Other names: SGN-35;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria | Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR | Up to 18.3 months | 
| Number of Participants With Adverse Events | An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment. | Up to 36 months | 
| Number of Participants With Laboratory Abnormalities | Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter. | Up to 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. | Up to 17.1 months | 
| Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. | up to 18.3 months | 
| Overall Survival (OS) | OS is defined as the time from date of enrollment to date of death due to any cause. | Up to 35.8 months | 
| Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria | CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) | Up to 18.3 months | 
| ORR Per Investigator Assessment According to Modified Lugano Response Criteria | Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment | Up to 18.3 months | 
| DOR Per Investigator Assessment According to Modified Lugano Response Criteria | Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first. | Up to 17.1 months | 
| Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria | PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first. | Up to 18.3 months | 
| Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria | CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014). | Up to 18.3 months | 
| ORR Per BICR According to Lugano Response Criteria | ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014) | Up to 18.3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CD30-expression, sALCL, PTCL, cHL, Seattle Genetics