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

September 26, 2023 updated by: Seagen Inc.

A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

131

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • University of Alberta / Cross Cancer Institute
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre - Victoria Hospital
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
      • Montreal, Quebec, Canada, H1T 2M4
        • CIUSSS de L'Est de l'lle de Montreal / installation Hopital Maisonneuve-Rosemont
      • Montreal, Quebec, Canada, H4A 3J1
        • Royal Victoria Hospital, McGill University Health Centre
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249
        • University of Alabama at Birmingham
      • Mobile, Alabama, United States, 36604
        • University of South Alabama - Mitchell Cancer Institute
    • Alaska
      • Anchorage, Alaska, United States, 99503
        • Alaska Urological Institute
    • Arizona
      • Gilbert, Arizona, United States, 85234
        • Banner MD Anderson Cancer Center
      • Tucson, Arizona, United States, 85710
        • Arizona Oncology Associates, PC - HOPE
      • Tucson, Arizona, United States, 85724-5024
        • Arizona Cancer Center / University of Arizona
    • Arkansas
      • Springdale, Arkansas, United States, J. Thaddeus Beck
        • Highlands Oncology Group
    • California
      • Burbank, California, United States, 91505
        • Providence St Joseph Medical Center
      • Duarte, California, United States, 91010
        • City of Hope National Medical Center
      • Pomona, California, United States, 91767
        • Wilshire Oncology Medical Group Inc.
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Rocky Mountain Cancer Centers - Aurora
    • Florida
      • Trinity, Florida, United States, 34655
        • Florida Cancer Affiliates
    • Georgia
      • Columbus, Georgia, United States, 31904
        • IACT Health
      • Sandy Springs, Georgia, United States, 30341
        • Georgia Cancer Specialists / Northside Hospital Cancer Institute
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Niles, Illinois, United States, 60714
        • Illinois Cancer Specialists / Advocate Lutheran General Hospital
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • American Oncology Networks LLC
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute / Wayne State University
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Minnesota Oncology Hematology P.A.
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Nebraska Cancer Specialists
    • Nevada
      • Las Vegas, Nevada, United States, 89169
        • Comprehensive Cancer Centers of Nevada
    • New Jersey
      • Morristown, New Jersey, United States, 07960
        • Morristown Medical Center/ Carol G. Simon Cancer Center
      • New Brunswick, New Jersey, United States, 08903
        • Rutgers Cancer Institute of New Jersey
    • New York
      • Albany, New York, United States, 12208
        • New York Oncology Hematology, P.C.
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • Rochester, New York, United States, 14642
        • James P. Wilmot Cancer Center / University of Rochester Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Oncology Hematology Care
      • Columbus, Ohio, United States, 43210
        • James Cancer Hospital / Ohio State University
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Willamette Valley Cancer Institute and Research Center
      • Tigard, Oregon, United States, 97223
        • Northwest Cancer Specialists, P.C.
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Prisma Health
    • Texas
      • Arlington, Texas, United States, 76012
        • Arlington Cancer Center
      • Bedford, Texas, United States, 76022
        • Texas Oncology - Bedford
      • Dallas, Texas, United States, 75231
        • Texas Oncology - Presbyterian Cancer Center Dallas
      • Denton, Texas, United States, Kurkul
        • Texas Oncology - Denton South
      • Fort Worth, Texas, United States, 76104
        • Texas Oncology - Fort Worth 12th Avenue
      • Houston, Texas, United States, 77030
        • Houston Methodist Cancer Center
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center / University of Texas
      • Longview, Texas, United States, 75601
        • Texas Oncology - Longview
      • McAllen, Texas, United States, 78503
        • Texas Oncology - McAllen
      • Round Rock, Texas, United States, 78665
        • Texas Oncology - Seton Williamson
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Virginia Cancer Specialists, PC
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University Medical Center
      • Salem, Virginia, United States, 24153
        • Oncology and Hematology Assoc of SW VA DBA Blue Ridge Cancer Care
      • Winchester, Virginia, United States, 22601
        • Shenandoah Oncology P.C.
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute/Virginia Mason Medical Center
      • Wenatchee, Washington, United States, 98821
        • Wenatchee Valley Medical Center
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Carbone Cancer Center / University of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part A: Brentuximab Vedotin in HL Patients
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • Adcetris; SGN-35
Experimental: Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • Adcetris; SGN-35
Drug: dacarbazine
375 mg/m^2 every 3 weeks by IV infusion
Experimental: Part C: Brentuximab Vedotin + Bendamustine in HL Patients
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • Adcetris; SGN-35
Drug: bendamustine
70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle
Experimental: Part D: Brentuximab Vedotin + Nivolumab in HL Patients
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • Adcetris; SGN-35
Drug: nivolumab
3 mg/kg every 3 weeks by IV infusion
Experimental: Part E: Brentuximab Vedotin in HL Patients
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • Adcetris; SGN-35
Experimental: Part F: Brentuximab Vedotin in PTCL Patients
Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Names:
  • Adcetris; SGN-35

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) according to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
Time Frame: Through 1 month following last dose; up to approximately 16 months
Defined as the proportion of patients with complete response (CR) or (PR)
Through 1 month following last dose; up to approximately 16 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)
Time Frame: Through 1 month following last dose; up to approximately 16 months
Through 1 month following last dose; up to approximately 16 months
ORR according to modified Lugano criteria per blinded independent central review (BICR) (Parts E and F)
Time Frame: Through 1 month following last dose; up to approximately 16 months
Through 1 month following last dose; up to approximately 16 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
Incidence of laboratory abnormalities
Time Frame: Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
Through 1 month following last dose of brentuximab vedotin (all parts) or through 100 days after last dose of nivolumab (Part D only); up to approximately 18 months
Complete remission (CR) rate
Time Frame: Through 1 month following last dose; up to approximately 16 months
Defined as the proportion of patients with CR
Through 1 month following last dose; up to approximately 16 months
Duration of complete response
Time Frame: Up to approximately 10 years
Defined as the time from start of the first documentation of complete tumor response (CR) to the first documentation of tumor progression or death
Up to approximately 10 years
Duration of objective response
Time Frame: Up to approximately 10 years
Defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression or death
Up to approximately 10 years
Progression-free survival
Time Frame: Up to approximately 10 years
Defined as the time from start of study treatment to first documentation of tumor progression or death due to any cause
Up to approximately 10 years
Disease control rate
Time Frame: Up to approximately 10 years
Defined as the proportion of patients with CR, PR, or stable disease (SD)
Up to approximately 10 years
ORR according to Lugano criteria per BICR (Parts E and F)
Time Frame: Through 1 month following last dose; up to approximately 16 months
Through 1 month following last dose; up to approximately 16 months
B symptom resolution rate
Time Frame: Through 1 month following last dose; up to approximately 16 months
Defined as the proportion of patients with lymphoma-related B symptoms at baseline who achieve resolution of all B symptoms at any time during the treatment period
Through 1 month following last dose; up to approximately 16 months
Blood concentrations of brentuximab vedotin
Time Frame: Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes
Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose; Cycles 2 and later (through 1 month post last dose): pre-dose and 30 minutes
Incidence of brentuximab vedotin antitherapeutic antibodies (ATA)
Time Frame: Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose
Defined as the proportion of patients who develop ATA to brentuximab vedotin at any time during the study
Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 1 month post last dose [Parts A, B, and C] or through 100 days post last dose of nivolumab [Part D only]): predose
Blood concentrations of nivolumab (Part D only)
Time Frame: Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes
Up to approximately 16 months. Cycle 1: predose, 30 minutes, and 168 and 336 hours post-dose; Cycles 2, 4, and every 4 cycles thereafter (through 1 month post last dose): pre-dose and 30 minutes
Incidence of nivolumab antitherapeutic antibodies (ATA) (Part D only)
Time Frame: Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose
Defined as the proportion of patients who develop ATA to nivolumab at any time during the study
Up to approximately 18 months. Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose
Overall survival (Parts E and F only)
Time Frame: Up to approximately 5 years
Defined as the time from start of study treatment to date of death due to any cause
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seagen Inc.

Collaborators

Bristol-Myers Squibb

Investigators

  • Study Director: Robert Sims, MD, Seagen Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2012

Primary Completion (Actual)

April 7, 2023

Study Completion (Actual)

September 12, 2023

Study Registration Dates

First Submitted

October 16, 2012

First Submitted That Met QC Criteria

October 25, 2012

First Posted (Estimated)

October 30, 2012

Study Record Updates

Last Update Posted (Actual)

September 28, 2023

Last Update Submitted That Met QC Criteria

September 26, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGN35-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hodgkin Disease

Clinical Trials on brentuximab vedotin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe