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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Seattle Genetics, Inc.
Information provided by (Responsible Party):
Millennium Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier:
NCT01578499
First received: March 27, 2012
Last updated: January 6, 2016
Last verified: January 2016
  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


Enrollment: 132
Study Start Date: August 2012
Estimated Study Completion Date: July 2018
Estimated Primary Completion Date: May 2016 (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   (Adult, Senior)
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

  Show 41 Study Locations
Sponsors and Collaborators
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Investigators
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
  More Information

Additional Information:
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: January 6, 2016
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Millennium Pharmaceuticals, Inc.:
brentuximab vedotin
ALCANZA

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

ClinicalTrials.gov processed this record on September 28, 2016