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 June 2014 by Seattle Genetics, Inc.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01716806
First received: October 16, 2012
Last updated: June 30, 2014
Last verified: June 2014
  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) in front-line therapy of HL in adults age 60 and above.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Complete remission rate (CR) [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Participants will be followed for an average of 2 years ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Participants will be followed for an average of 2 years ] [ Designated as safety issue: No ]
  • B symptom resolution rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Incidence of antitherapeutic antibodies (ATA) [ Time Frame: Cycles 1, 2, 4, and every 4 cycles thereafter: predose, and 1 month post last dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2015 (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: BrentuximabVedotin + 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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

  Show 23 Study Locations
Sponsors and Collaborators
Seattle Genetics, Inc.
Investigators
Study Director: Corinna Palanca-Wessels, MD, PhD Seattle Genetics, Inc.
  More Information

No publications provided

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: June 30, 2014
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on July 28, 2014