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

Phase 2TerminatedNCT03947255

Seagen Inc.12 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hodgkin Lymphoma Peripheral T Cell Lymphoma Anaplastic Large Cell Lymphoma

Interventions

brentuximab vedotinDRUG

1.8 mg/kg given intravenously (IV)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (19)

Pacific Cancer Medical Center

Anaheim, California, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 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.

Time frame: Up to 36 months

Secondary Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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