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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

Phase 3
18 Years
Open (Enrolling)
Primary Cutaneous Anaplastic Large Cell Lymphoma,, Mycosis Fungoides, Cutaneous T-Cell Lymphoma

Thank you

Trial Information

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

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

- 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

- Known active cerebral/meningeal disease, HIV infection, hepatitis B or Hepatitis C

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of patients achieving an objective response that lasts at least 4 months

Outcome Description:

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

Outcome 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

Safety Issue:


Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Millennium Pharmaceuticals, Inc.


United States: Food and Drug Administration

Study ID:




Start Date:

May 2012

Completion Date:

May 2017

Related Keywords:

  • Primary Cutaneous Anaplastic Large Cell Lymphoma,
  • Mycosis Fungoides
  • Cutaneous T-cell Lymphoma
  • Lymphoma
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Mycoses
  • Mycosis Fungoides
  • Lymphoma, T-Cell
  • Lymphoma, T-Cell, Cutaneous
  • Lymphoma, Large-Cell, Anaplastic
  • Lymphoma, Primary Cutaneous Anaplastic Large Cell



MD Anderson Cancer Center Houston, Texas  77030-4096
Northwestern Memorial Hospital Chicago, Illinois  60611
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Stanford Cancer Center Stanford, California  94305-5824
University of Pittsburgh Pittsburgh, Pennsylvania  15261
Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Boston University Medical Center Boston, Massachusetts  02118
John Theurer Cancer Center (Hackensack University Medical Center) Hackensack, New Jersey  07601
UCLA Hematology Oncology Santa Monica, California  90404