Trial Search Results

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)

The primary purpose of the study is to determine overall response rate of study drug brentuximab vedotin in patients with CD-30 positive mycosis fungoides (CD30+MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL) compared to that achieved with therapy in the control arm. The study is investigating that the overall response rate of the study drug brentuximab vedotin is at least 4 months.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Millennium Pharmaceuticals, Inc.

Collaborator: Seattle Genetics, Inc.

Stanford Investigator(s):

Intervention(s):

  • Drug: Brentuximab Vedotin
  • Drug: Methotrexate
  • Drug: Bexarotene

Phase:

Phase 3

Eligibility


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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting