Overview

This trial is active, not recruiting.

Conditions primary cutaneous anaplastic large cell lymphoma,, mycosis fungoides, cutaneous t-cell lymphoma
Treatments brentuximab vedotin, methotrexate or bexarotene
Phase phase 3
Targets CD30, TNF-alpha
Sponsor Millennium Pharmaceuticals, Inc.
Collaborator Seattle Genetics, Inc.
Start date August 2012
End date May 2016
Trial size 132 participants
Trial identifier NCT01578499, 2010-024215-14, C25001

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Methotrexate or Bexarotene as per physician's choice
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)
Brentuximab Vedotin Monotherapy
brentuximab vedotin SGN-35
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)

Primary Outcomes

Measure
Proportion of patients achieving an objective response that lasts at least 4 months
time frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient)

Secondary Outcomes

Measure
Proportion of patients achieving complete response (CR)
time frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient)
Progression-free survival (PFS)
time frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient)
Changes in symptom domain per Skindex-29 questionnaire
time frame: Until disease progression, death or study closure (up to 3 years after the enrollment of the last patient)

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Voluntary consent form - Male or female patients 18 years or older with diagnosis of MF or pcALCL - Patients with pcALCL who have received prior radiation therapy or at least 1 prior systemic therapy; patients 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 patients 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 subject - Male patients 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 subject - Clinical laboratory values as specified in protocol Exclusion Criteria: - A concurrent diagnosis of systemic ALCL,other non Hodgkin lymphoma(excluding LyP) or Sezary syndrome or B2 disease - 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 3 weeks of study entry - Corticosteroid therapy within 3 weeks or immunosuppressive chemotherapy or any antibody-directed or immunoglobulin-based immune therapy (eg, immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first dose of study drug - Female patients 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.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in January 2016.
Information provided to ClinicalTrials.gov by Millennium Pharmaceuticals, Inc..
Location data was received from the National Cancer Institute and was last updated in August 2016.