Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01716806
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : August 4, 2020
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.

Tracking Information
First Submitted Date  ICMJE October 16, 2012
First Posted Date  ICMJE October 30, 2012
Last Update Posted Date August 4, 2020
Actual Study Start Date  ICMJE October 31, 2012
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2019)
  • 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)
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 25, 2012)
Objective response rate [ Time Frame: Through 1 month following last dose ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2019)
  • 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 ]
  • 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 ]
  • 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
  • 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
  • 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
  • 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
  • Disease control rate [ Time Frame: Up to approximately 10 years ]
    Defined as the proportion of patients with CR, PR, or stable disease (SD)
  • ORR according to Lugano criteria per BICR (Parts E and F) [ Time Frame: 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
  • 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 ]
  • 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
  • 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 ]
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2012)
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ]
  • Complete remission rate (CR) [ Time Frame: Through 1 month following last dose ]
  • Duration of response [ Time Frame: Participants will be followed for an average of 2 years ]
  • Progression-free survival [ Time Frame: Participants will be followed for an average of 2 years ]
  • B symptom resolution rate [ Time Frame: Through 1 month following last dose ]
  • Blood concentrations of brentuximab vedotin and metabolites [ Time Frame: Cycle 1: predose, 30 minutes, and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose, 30 minutes, and 1 month post last dose ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, 8, 12, 16: predose, and 1 month post last dose ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
Official Title  ICMJE 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
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hodgkin Disease
  • Peripheral T Cell Lymphoma
Intervention  ICMJE
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other Name: Adcetris; SGN-35
  • Drug: bendamustine
    70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle
  • Drug: dacarbazine
    375 mg/m^2 every 3 weeks by IV infusion
  • Drug: nivolumab
    3 mg/kg every 3 weeks by IV infusion
Study Arms  ICMJE
  • Experimental: Part A: Brentuximab Vedotin in HL Patients
    Intervention: Drug: brentuximab vedotin
  • Experimental: Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
    Interventions:
    • Drug: brentuximab vedotin
    • Drug: dacarbazine
  • Experimental: Part C: Brentuximab Vedotin + Bendamustine in HL Patients
    Interventions:
    • Drug: brentuximab vedotin
    • Drug: bendamustine
  • Experimental: Part D: Brentuximab Vedotin + Nivolumab in HL Patients
    Interventions:
    • Drug: brentuximab vedotin
    • Drug: nivolumab
  • Experimental: Part E: Brentuximab Vedotin in HL Patients
    Intervention: Drug: brentuximab vedotin
  • Experimental: Part F: Brentuximab Vedotin in PTCL Patients
    Intervention: Drug: brentuximab vedotin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 6, 2019)
180
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2012)
20
Estimated Study Completion Date  ICMJE September 30, 2024
Estimated Primary Completion Date September 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01716806
Other Study ID Numbers  ICMJE SGN35-015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Seattle Genetics, Inc.
Study Sponsor  ICMJE Seattle Genetics, Inc.
Collaborators  ICMJE Bristol-Myers Squibb
Investigators  ICMJE
Study Director: Robert Sims, MD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date July 31, 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP