A Phase 3 Trial of Brentuximab Vedotin(SGN-35) Versus Physician's Choice (Methotrexate or Bexarotene) in Participants With CD30-Positive Cutaneous T-Cell Lymphoma (ALCANZA Study)
Condition: Primary Cutaneous Anaplastic Large Cell Lymphoma; Mycosis Fungoides; Cutaneous T-Cell Lymphoma
MeSH terms: Mycoses; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral; Mycosis Fungoides; Lymphoma, Large-Cell, Anaplastic; Lymphoma, T-Cell, Cutaneous; Lymphoma, Primary Cutaneous Anaplastic Large Cell
Intervention: Brentuximab Vedotin; Methotrexate; Bexarotene
Intervention description: Brentuximab vedotin intravenous injection.; Methotrexate tablets.; Bexarotene tablets.
Intervention MeSH terms: Methotrexate; Brentuximab Vedotin; Bexarotene
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 131.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Brentuximab vedotin; ALCANZA

Summary:

      The purpose of this study is to determine objective response rate (ORR), lasting at least 4
      months (ORR4), with brentuximab vedotin in participants with cluster of differentiation
      antigen 30 positive (CD30+) cutaneous T-cell lymphoma [mycosis fungoides (MF) and primary
      cutaneous anaplastic large cell lymphoma (pcALCL) ]compared to that achieved with therapy in
      the control arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Voluntary consent form

          -  Male or female participants 18 years or older with diagnosis of mycosis fungoides (MF)
             or primary cutaneous anaplastic large cell lymphoma (pcALCL)

          -  Participants with pcALCL who have received prior radiation therapy or at least 1 prior
             systemic therapy; participants 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 participants 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 participant

          -  Male participants 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 participant

          -  Clinical laboratory values as specified in protocol

          -  A 3-week washout period is required from previous treatments (with the exception of a
             12-week washout for antibody-directed or immunoglobulin-based immune therapy, or other
             monoclonal antibody therapies), unless it is not in the best interest of the patient
             in the opinion of the investigator. Individual cases should be discussed with the
             project clinician before enrollment.

        Exclusion Criteria:

          -  A concurrent diagnosis of systemic ALCL, or other non Hodgkin lymphoma (excluding LyP)
             or Sezary syndrome or B2 disease

          -  Participants with cardiovascular conditions specified in protocols

          -  Participants with history of another primary malignancy not in remission for at least
             3 years

          -  Known active cerebral/meningeal disease, including signs or symptoms of progressive
             multifocal leukoencephalopathy (PML);

          -  Known human immunodeficiency virus (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 (e.g., immunoglobulin
             replacement, other monoclonal antibody therapies) within 12 weeks of first dose of
             study drug

          -  Female participants 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.