A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Millennium Pharmaceuticals, Inc.
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01578499
First received: March 27, 2012
Last updated: August 18, 2013
Last verified: August 2013
  Purpose

This is a Randomized, Open-Label, Phase 3 trial of brentuximab vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma


Condition Intervention Phase
Primary Cutaneous Anaplastic Large Cell Lymphoma,
Mycosis Fungoides
Cutaneous T-Cell Lymphoma
Drug: Brentuximab Vedotin
Drug: Methotrexate or Bexarotene
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Open-Label, Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Patients With CD30-Positive Cutaneous T-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Millennium Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Proportion of patients achieving an objective response that lasts at least 4 months [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ] [ Designated as safety issue: No ]
    To determine ORR, lasting at least 4 months, with brentuximab vedotin in patients with CD30+ MF or pcALCL compared to that achieved with therapy in the control arm


Secondary Outcome Measures:
  • Proportion of patients achieving complete response (CR) [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ] [ Designated as safety issue: No ]
    To determine CR rate with brentuximab vedotin compared to that achieved with therapy in the control arm

  • Progression-free survival (PFS) [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ] [ Designated as safety issue: No ]
    To determine PFS with brentuximab vedotin compared to that achieved with therapy in the control arm

  • Changes in symptom domain per Skindex-29 questionnaire [ Time Frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient) ] [ Designated as safety issue: No ]
    To determine burden of symptoms during treatment with brentuximab vedotin compared to that achieved with therapy in the control arm


Estimated Enrollment: 124
Study Start Date: August 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Methotrexate or Bexarotene
Methotrexate or Bexarotene as per physician's choice
Drug: Methotrexate or Bexarotene
Methotrexate will be administered orally (5 to 50 mg) once weekly. Dose adjustment is guided by patient response and toxicity or Bexarotene will be administered orally (300 mg/m2) once daily with meals.
Experimental: Brentuximab Vedotin
Brentuximab Vedotin Monotherapy
Drug: Brentuximab Vedotin
Brentuximab vedotin (1.8 mg/kg) will be administered intravenously over approximately 30 minutes once every 21 days and may continue as monotherapy for up to a total of 16 cycles (48 weeks)
Other Name: SGN-35

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Voluntary consent form
  • Male or female patients 18 years or older with diagnosis of MF or pcALCL
  • Patients with pcALCL who have received prior radiation therapy or at least 1 prior systemic therapy; patients with MF who have received at least 1 prior systemic therapy
  • Histologically confirmed CD30+ disease by central laboratory assessment and pathology review
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  • Female patients who are post menopausal, surgically sterile, or agree to practice 2 effective methods of contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
  • Male patients who agree to practice effective barrier contraception or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject
  • Clinical laboratory values as specified in protocol

Exclusion Criteria:

  • A concurrent diagnosis of systemic ALCL,other non Hodgkin lymphoma(excluding LyP) or Sezary syndrome or B2 disease
  • Patients with cardiovascular conditions specified in protocols
  • Patients with history of another primary malignancy not in remission for at least 3 years
  • Known active cerebral/meningeal disease, HIV infection, hepatitis B or Hepatitis C infection
  • Oral retinoid therapy for any indication within 3 weeks of study entry
  • Corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug
  • Female patients who are lactating and breastfeeding or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle
  • Previous receipt of brentuximab vedotin

Please note that there are additional inclusion and exclusion criteria. The study center will determine if you meet all of the criteria.

Site personnel will explain the trial in detail and answer any question you may have if you do qualify for the study. You can then decide whether or not you wish to participate. If you do not qualify for the trial, site personnel will explain the reasons.

  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: NCT01578499

Contacts
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com

Locations
United States, California
UCLA Hematology Oncology Recruiting
Los Angeles, California, United States, 90095
Contact: Herbert Eradat         
Stanford Cancer Center Recruiting
Stanford, California, United States, 94305
United States, Florida
Moffitt Cancer Center and Research Institute Recruiting
Tampa, Florida, United States, 33612
Contact: Lubomir Sokol, MD         
United States, Illinois
Northwestern Memorial Hospital Recruiting
Chicago, Illinois, United States, 60611
United States, Massachusetts
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215-5450
Contact: David C Fisher         
United States, New Jersey
John Theurer Cancer Center (Hackensack University Medical Center) Recruiting
Hackensack, New Jersey, United States, 07601
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10021
Contact: Steven Horwitz         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Australia
Concord Repatriation General Hospital Recruiting
Concord, Australia
Peter MacCallum Cancer Centre Recruiting
East Melbourne, Australia
Sir Charles Gairdner Hospital Recruiting
Nedlands, Australia
Belgium
UZ Leuven Recruiting
Leuven, Belgium
Germany
Klinik für Dermatologie, Venerologie und Allergologie Recruiting
Kiel, Germany
Italy
A.O.U. Policlinico S.Orsola Malpighi Recruiting
Bologna, Italy
Spain
Hospital Universitario 12 de Octubre Recruiting
Madrid, Spain, 28041
United Kingdom
St. James University Hospital Recruiting
Leeds, United Kingdom, LS9 7TF
St. John's Institute of Dermatology Recruiting
London, United Kingdom, SE1 EH
Manchester Cancer Research Centre Recruiting
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

No publications provided

Responsible Party: Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT01578499     History of Changes
Other Study ID Numbers: C25001, 2010-024215-14
Study First Received: March 27, 2012
Last Updated: August 18, 2013
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Primary Cutaneous Anaplastic Large Cell
Lymphoma, T-Cell
Lymphoma, T-Cell, Cutaneous
Mycosis Fungoides
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Bexarotene
Methotrexate
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anticarcinogenic Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Antirheumatic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014