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

• 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

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

• 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

Inclusion Criteria:

• Voluntary consent form
• Male or female patients 18 years or older with diagnosis of MF or pcALCL
• Patients must have received at least 1 prior systemic therapy for their disease
• 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 abstain from heterosexual intercourse
• Male patients who agree to practice effective barrier contraception or agree to abstain from heterosexual intercourse
• Clinical laboratory value as specified in protocol

Exclusion Criteria:

• A concurrent diagnosis of systemic ALCL,other non Hodgkin lymphoma(excluding LyP) or Sezary syndrome
• 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 12 weeks of study entry
• Corticosteroid therapy within 4 weeks or immunosuppressive chemotherapy or any immunotherapy within 12 weeks of first dose of study drug
• Female patients who are lactating or have a positive serum pregnancy test during the screening period or a positive urine pregnancy test on Day 1 of any cycle

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.