A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

Seagen Inc.131 enrolled

Overview

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

131

Conditions

Hodgkin Disease Peripheral T Cell Lymphoma

Interventions

brentuximab vedotinDRUG

1.8 mg/kg every 3 weeks by IV infusion

bendamustineDRUG

70 mg/m\^2 by IV infusion on Days 1 and 2 of 3-week cycle

dacarbazineDRUG

375 mg/m\^2 every 3 weeks by IV infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Parts A, B, C, and D: 60 years of age or older * Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E) * Treatment-naive patients with CD30-expressing PTCL (Part F) * Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D) * Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by: * A CIRS score of 10 or greater * Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs) * Measurable disease of at least 1.5 cm as documented by radiographic technique * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D) Exclusion Criteria: * Symptomatic neurologic disease compromising IADLs or requiring medication * History of progressive multifocal leukoencephalopathy * Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin * Concurrent use of other investigational agents * Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug * History of another malignancy within 1 year before first dose of study drug (Parts E and F only) * Part D only: * Received any prior immune-oncology therapy * History of known or suspected autoimmune disease * Prior allogeneic stem cell transplant * History of cerebral vascular event within 6 months of first dose of study drug * Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology * Known history of pancreatitis * Parts D, E, and F only: * Known cerebral/meningeal disease related to the underlying malignancy * Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment

Locations (54)

Outcomes

Primary Outcomes

Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)

Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).

Time frame: Up to 81 months

ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)

Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).

Time frame: Up to 60 months

ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)

Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.

Time frame: Up to 31 months

Secondary Outcomes

Number of Participants With Adverse Events

A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.

Data from ClinicalTrials.gov

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