PatientsVille.com LogoPatientsVille.com

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?

Mycosis Fungoides

Sezary Syndrome

Study Interventions

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.

Drug:alemtuzumab

Study Arms

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.

Study Status

Unknown status

Start Date: July 2005

Completed Date: July 2008

Phase: Phase 2

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00157274

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.

Discuss Sezary