Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome|
- Overall response
- Time to relapse
- Event free survival
|Study Start Date:||July 2005|
|Estimated Study Completion Date:||July 2008|
- 20 relapsed or refractory advanced mycosis fungoides/Sezary syndrome patients are scheduled with gradually escalated doses (3 mg, 10 mg , and 30 mg) on sequential days during the first week, followed by 30 mg three times a week until 12 weeks.
- Patients must have serology negative for human T-lymphotropic virus 1 (HTLV-1) and until three different regimens of chemotherapy.
- Follow up for one year after last cycle of alemtuzumab.
|Contact: Julia M Huamani, MDfirstname.lastname@example.org|
|Schering Peruana S.A.||Recruiting|
|Lima, Peru, 511|
|Contact: Jesus A Arones, MD 99480078 email@example.com|
|Principal Investigator:||Brady E Beltran, MD||LACOGH - PERU|