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A Phase 1 Study of Brentuximab Vedotin Combined With ABVD for Hodgkin Lymphoma
This study is currently recruiting participants.
Verified by Seattle Genetics, Inc., August 2010
First Received: January 29, 2010   Last Updated: August 24, 2010   History of Changes
Sponsor: Seattle Genetics, Inc.
Collaborator: Millennium Pharmaceuticals, Inc.
Information provided by: Seattle Genetics, Inc.
ClinicalTrials.gov Identifier: NCT01060904
  Purpose

The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with ABVD in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, single-arm, open-label dose escalation study designed to define the MTD, PK, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.


Condition Intervention Phase
Disease, Hodgkin
Drug: brentuximab vedotin
Drug: doxorubicin
Drug: vinblastine
Drug: dacarbazine
Drug: bleomycin
Phase I

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With ABVD as Frontline Therapy in Patients With Hodgkin Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Incidence of adverse events and laboratory abnormalities [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Brentuximab vedotin concentration in blood [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: No ]
  • Antitherapeutic antibodies in blood [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: Yes ]
  • Best clinical response [ Time Frame: Through 1 month after last dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2010
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
Drug: brentuximab vedotin
0.6-1.2 mg/kg IV every 2 weeks
Drug: doxorubicin
25 mg/m2 IV every 2 weeks
Drug: vinblastine
6 mg/m2 IV every 2 weeks
Drug: dacarbazine
375 mg/m2 IV every 2 weeks
Drug: bleomycin
10 units/m2 IV every 2 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV
  • Measurable disease of at least 1.5 cm
  • ECOG performance status <3

Exclusion Criteria:

  • History of another primary malignancy that has not been in remission for at least 3 years
  • Known cerebral/meningeal disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060904

Contacts
Contact: Terri Lowe 866-333-7436 clinicaltrials@seagen.com

Locations
United States, Minnesota
Mayo Clinic Rochester Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tami Simmons     507-284-4740     simmons.tamera@mayo.edu    
Principal Investigator: Stephen Ansell, M.D. Ph.D            
United States, Texas
MD Anderson Cancer Center / University of Texas Recruiting
Houston, Texas, United States, 77030-4009
Contact: Amanda Copeland     713-792-9455     arcopeland@mdanderson.org    
Principal Investigator: Anas Younes, MD            
Canada, British Columbia
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Daphne Brockington     604-877-6000 X2631     dbrockington@bccancer.bc.ca    
Principal Investigator: Joseph Connors, M.D.            
Sponsors and Collaborators
Seattle Genetics, Inc.
Millennium Pharmaceuticals, Inc.
Investigators
Study Director: Muriel Siadak, PA-C Seattle Genetics, Inc.
  More Information

No publications provided

Responsible Party: Seattle Genetics, Inc. ( Muriel Siadak, PA-C )
ClinicalTrials.gov Identifier: NCT01060904     History of Changes
Other Study ID Numbers: SGN35-009
Study First Received: January 29, 2010
Last Updated: August 24, 2010
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 07, 2010