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

March 27, 2012
August 18, 2013
August 2012
April 2015   (final data collection date for primary outcome measure)
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
Proportion of patients achieving an objective response that lasts at least 4 months [ Time Frame: Change in response at the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ] [ 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
Complete list of historical versions of study NCT01578499 on ClinicalTrials.gov Archive Site
  • 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
  • Proportion of patients achieving complete response (CR) [ Time Frame: At the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ] [ 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: At the end of 21 day cycles: 3,6,9,12, and 15; at EOT; then every 12 weeks for a minimum of 24 months, and thereafter every 6 months until disease progression or study closure for up to 3 years post treatment ] [ 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: Day 1 of 21 day cycles: 1,2,4,6,8,10,12,14, and 16; At EOT 30 days after the last dose, and during post treatment follow-up (for up to 3 years post treatment) ] [ 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
Not Provided
Not Provided
 
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
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Primary Cutaneous Anaplastic Large Cell Lymphoma,
  • Mycosis Fungoides
  • Cutaneous T-Cell Lymphoma
  • 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
  • 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: Methotrexate or Bexarotene
    Methotrexate or Bexarotene as per physician's choice
    Intervention: Drug: Methotrexate or Bexarotene
  • Experimental: Brentuximab Vedotin
    Brentuximab Vedotin Monotherapy
    Intervention: Drug: Brentuximab Vedotin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
124
June 2015
April 2015   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact: For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 medical@mlnm.com
United States,   Australia,   Belgium,   Germany,   Italy,   Spain,   United Kingdom
 
NCT01578499
C25001, 2010-024215-14
Yes
Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
Study Director: Medical Monitor Millennium Pharmaceuticals, Inc.
Millennium Pharmaceuticals, Inc.
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP