Mycosis Fungoides Clinical Trial
Official title:
Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
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.
- 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.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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