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
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
- 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
- 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.
Millennium Pharmaceuticals, Inc.
Seattle Genetics, Inc.
For an updated listing of recruitment sites contact: Millennium Medical and Drug Information Center 1-877-674-3784 or firstname.lastname@example.org