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Clinical Trial DRUG C25001

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
Principal Investigator
Timothy Kuzel
Details
  • Status: Accepting New Patients
  • Study Type: Therapeutic, Treatment
  • Protocol No:.DRUG C25001
Purpose
The main purpose of this research is to determine if brentuximab vedotin (SGN-35) improves the outcome of treatment in patients with your type of Cutaneous T-Cell Lymphoma (CTCL) over selected standard therapy (methotrexate or bexarotene). This research will evaluate the proportion of patients achieving an objective response that lasts at least 4 months. Improvement measures also include overall response rate (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.
Overview
This study is for patients who have been diagnosed with CD30-Positive MF or pcALCL, which are types of Cutaneous T-Cell Lymphoma (CTCL). CD30 appears on the surface of some types of CTCL cancer cells and subtypes such as cutaneous anaplastic large cell lymphoma or mycosis fungoides. In this study, participants will be given either brentuximab vedotin (SGN-35) or the current therapy/standard of care for their cancer/lymphoma (methotrexate or bexarotene, depending on your study doctor’s choice). The use of brentuximab vedotin (SGN-35) in this study is investigational.
Eligibility
Some of the eligibility criteria include:
  • Participants in this study must be 18 years of age or older.
  • Participants must have CD30+ mycosis fungoides or CD30+ primary cutaneous anaplastic large cell lymphoma.
  • Participants must have received at least 1 prior systemic therapy for their disease.
Note: This is only a partial list of eligibility criteria. Please contact the Lurie Cancer Center for complete screening information if you are interested in this clinical trial.
Description of Treatment
Study participants will be randomly assigned to receive either brentuximab vedotin (SGN-35) or a standard of care/current therapy (methotrexate or bexarotene). Treatment may be received for up to 48 weeks. Participants assigned to receive brentuximab vedotin (SGN-35) will receive study drug by intravenous (through a vein) infusion over approximately 30 minutes every 21 days. Each 21 day treatment period is called a cycle, and brentuximab vedotin (SGN-35) is given on the first day of the cycle. Participants may receive it for up to 16 cycles (48 weeks). For participants assigned to receive a standard therapy, the study doctor will decide whether they will receive methotrexate or bexarotene. Both methotrexate and bexarotene are oral medicines which can be taken at home. Methotrexate is a pill to be taken once a week. Bexarotene is a capsule to be taken once a day with a meal. A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by U.S. Law. Please refer to this website for more information.
Contact
Sara Duffey
Clinical Research and Education Specialist
Robert H. Lurie Comprehensive Cancer Center
312.695.1102
cancertrials@northwestern.edu

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last updated: 21-Dec-14 04:41 AM

 

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