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Clinical Trial 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.


Clinical Trial Description

- 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. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00157274
Study type Interventional
Source Latin American Cooperative Onco-Haematology Group - Peru
Contact Julia M Huamani, MD
Phone 511-2227020
Email juliahuamaniz@yahoo.es
Status Recruiting
Phase Phase 2
Start date July 2005
Completion date July 2008

See also
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