Clinical Trial: Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
Study Status: Active, not recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
Brief Summary: 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.
Detailed Summary:
- 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.
Sponsor: Latin American Cooperative Onco-Haematology Group - Peru
Current Primary Outcome:
- Overall response
- Time to relapse
- Event free survival
Original Primary Outcome: Same as current
Current Secondary Outcome: Toxicity
Original Secondary Outcome: Same as current
Information By: Latin American Cooperative Onco-Haematology Group - Peru
Dates:
Date Received: September 7, 2005
Date Started: July 2005
Date Completion: July 2008
Last Updated: April 2, 2007
Last Verified: September 2005
