Mycosis Fungoides | Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
Mycosis Fungoides research study
What is the primary objective of this study?
The investigators designed a compassionate basis phase II study for refractory/relapsed mycosis fungoides/Sezary syndrome consisting of alemtuzumab (Campath) for primary evaluation of overall response and time to relapse. Other goals to consider are toxicity and time to new therapy.
Who is eligible to participate?
Inclusion Criteria: - Above 18 years old - Eastern Cooperative Oncology Group (ECOG) 0-2 - Liver and renal function test less than twice upper label - No active infection - Written informed consent - One to three regimens of previous chemotherapies Exclusion Criteria: - Abnormal renal or hepatic function - Mycosis fungoides/Sezary syndrome in transformation - HIV + - HTLV-1 + - Pregnancy - Lactation
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2005
Completed Date: July 2008
Phase: Phase 2
Primary Outcome: Overall response
Secondary Outcome: Toxicity
Study sponsors, principal investigator, and references
Principal Investigator: Brady E Beltran, MD
Lead Sponsor: Latin American Cooperative Onco-Haematology Group - Peru
Lundin J, Hagberg H, Repp R, Cavallin-Ståhl E, Fredén S, Juliusson G, Rosenblad E, Tjønnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. Epub 2003 Jan 23.