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

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)

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.

Study Overview

• Status: Terminated
• Conditions: Hodgkin Lymphoma; Anaplastic Large Cell Lymphoma; Peripheral T Cell Lymphoma
• Intervention / Treatment: Drug: brentuximab vedotin

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Anaheim, California, United States, 92801
      • Pacific Cancer Medical Center
  • Colorado
    • Lafayette, Colorado, United States, 80026
      • SCL Health Good Samaritan Medical Center Cancer Centers of Colorado
  • Florida
    • Pembroke Pines, Florida, United States, 33028
      • Memorial Cancer Institute
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Northwest Oncology and Hematology/AMITA
    • Maywood, Illinois, United States, 60153
      • Cardinal Bernardin Cancer Center / Loyola University Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40207
      • Norton Cancer Institute
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospital and Clinic
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University of Maryland
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Karmanos Cancer Institute / Wayne State University
  • Missouri
    • Saint Louis, Missouri, United States, 63103
      • Saint Louis University
  • Nevada
    • Las Vegas, Nevada, United States, 89169
      • Comprehensive Cancer Centers of Nevada
  • New Jersey
    • Florham Park, New Jersey, United States, 07932
      • Summit Medical Group
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina/Hollings Cancer Center
  • Texas
    • Dallas, Texas, United States, 75246
      • Texas Oncology - Fort Worth
    • Fort Worth, Texas, United States, 76104
      • Texas Oncology - Fort Worth 12th Avenue
    • Fort Worth, Texas, United States, 76104
      • The Center for Cancer and Blood Disorders: Fortworth
    • Houston, Texas, United States, 77030-4095
      • MD Anderson Cancer Center / University of Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Cancer Center
    • San Antonio, Texas, United States, 78240
      • Texas Oncology - San Antonio Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Brentuximab vedotin	Drug: brentuximab vedotin; 1.8 mg/kg given intravenously (IV); Other Names: SGN-35; ADCETRIS

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seagen Inc.
• Investigators: Study Director: Dominic Lai, MD, Seagen Inc.

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2019
• Primary Completion (Actual): November 6, 2022
• Study Completion (Actual): November 6, 2022

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 9, 2019
• First Posted (Actual): May 13, 2019

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 11, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: PTCL; Seattle Genetics; CD30-expression; sALCL; cHL
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hodgkin Disease; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Lymphoma, Large-Cell, Anaplastic; Physiological Effects of Drugs; Antineoplastic Agents; Immunologic Factors; Antineoplastic Agents, Immunological; Immunoconjugates; Immunotoxins; Brentuximab Vedotin
• Other Study ID Numbers: SGN35-028

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No