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A Study of Brentuximab Vedotin in Adults Age 60 and Above With Newly Diagnosed Hodgkin Lymphoma (HL)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Seattle Genetics, Inc.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01716806
First received: October 16, 2012
Last updated: January 27, 2017
Last verified: January 2017
  Purpose
This is an open-label, multicenter, phase 2 clinical trial designed to evaluate the efficacy and safety of brentuximab vedotin as a single-agent (Part A) and in combination with dacarbazine (Part B), bendamustine (Part C), or nivolumab (Part D) in front-line therapy of HL in adults age 60 and above.

Condition Intervention Phase
Hodgkin Disease
Drug: brentuximab vedotin
Drug: bendamustine
Drug: dacarbazine
Drug: nivolumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) in Adults Age 60 and Above

Resource links provided by NLM:


Further study details as provided by Seattle Genetics, Inc.:

Primary Outcome Measures:
  • Objective response rate [ Time Frame: Through 1 month following last dose ]

Secondary Outcome Measures:
  • 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) ]
  • 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) ]
  • 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 (through 1 month post last dose): pre-dose and 30 minutes ]
  • Incidence of brentuximab vedotin antitherapeutic antibodies (ATA) [ Time Frame: 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 and metabolites [ Time Frame: 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: Cycles 1, 2, 4, and every 4 cycles thereafter (through 100 days post last dose of nivolumab): predose ]

Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brentuximab Vedotin Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Experimental: Brentuximab Vedotin + Dacarbazine Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Drug: dacarbazine
375 mg/m2 every 3 weeks by IV infusion
Experimental: Brentuximab Vedotin + Bendamustine 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
Experimental: Brentuximab Vedotin + Nivolumab Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV infusion
Other Name: Adcetris; SGN-35
Drug: nivolumab
3 mg/kg every 3 weeks by IV infusion

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histopathologically-confirmed diagnosis of classical Hodgkin lymphoma
  • Ineligible for or have declined initial conventional combination chemotherapy
  • Measurable disease of at least 1.5 cm as documented by radiographic technique
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01716806

Contacts
Contact: Seattle Genetics Trial Information Support 866-333-7436 clinicaltrials@seagen.com

  Show 23 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Bristol-Myers Squibb
Investigators
Study Director: Abraham Fong, MD, PhD Seattle Genetics, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01716806     History of Changes
Other Study ID Numbers: SGN35-015 
Study First Received: October 16, 2012
Last Updated: January 27, 2017

Keywords provided by Seattle Genetics, Inc.:
Antibody-Drug Conjugate
Antibodies, Monoclonal
Hematologic Diseases
Hodgkin Disease
Antigens, CD30
Lymphoma
monomethylauristatin E
Drug Therapy

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies
Antibodies, Monoclonal
Bendamustine Hydrochloride
Nivolumab
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 17, 2017