NCT00157274

Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (planned)
• Sponsor: Latin American Cooperative Onco-Haematology Group - Peru · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Mycosis Fungoides
• Sezary Syndrome

Interventions

Type	Name	Description
DRUG	alemtuzumab

Timeline

• Start date: 2005-07-01
• Completion: 2008-07-01
• First posted: 2005-09-12
• Last updated: 2007-04-03

Locations

1 site across 1 country: Peru