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A Study of Brentuximab Vedotin in Adults Age 60 and Above With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

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ClinicalTrials.gov Identifier: NCT01716806
Recruitment Status : Recruiting
First Posted : October 30, 2012
Last Update Posted : May 29, 2019
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 May 29, 2019
Actual Study Start Date  ICMJE October 2012
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2019)
Objective response rate [ 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 Complete list of historical versions of study NCT01716806 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 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 ]
  • Duration of complete response [ Time Frame: Up to approximately 10 years ]
  • Duration of objective response [ Time Frame: Up to approximately 10 years ]
  • Progression-free survival [ Time Frame: Up to approximately 10 years ]
  • Disease control rate [ Time Frame: Up to approximately 10 years ]
  • B symptom resolution rate [ Time Frame: 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 ]
  • 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 ]
  • Blood concentrations of nivolumab [ 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) [ 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 ]
  • Overall survival (Parts E and F only) [ Time Frame: Up to approximately 5 years ]
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 in Adults Age 60 and Above 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 Adults Age 60 and Above
Brief Summary This trial will study brentuximab vedotin to find out whether it is an effective treatment in patients 60 years or older for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). 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 in patients who are age 60 years or more. 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/m2 by IV infusion on Days 1 and 2 of 3-week cycle
  • Drug: dacarbazine
    375 mg/m2 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: May 9, 2019)
160
Original Estimated Enrollment  ICMJE
 (submitted: October 25, 2012)
20
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
  • Treatment-naïve patients with CD30-expressing PTCL (Part F)
  • 75+ years of age or 60+ years and have depressed ejection fraction or moderately severe renal dysfunction (Parts E and F only)
  • Ineligible for initial conventional combination chemotherapy for HL (Parts A, B, C, D, E) or CD30-expressing PTCL (Part F), or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
  • 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

Exclusion Criteria:

  • Symptomatic neurologic disease compromising instrumental activities of daily living or requiring medication
  • 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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 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: Linda Ho, MD Seattle Genetics, Inc.
PRS Account Seattle Genetics, Inc.
Verification Date May 24, 2019

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