Status:
UNKNOWN
Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
Lead Sponsor:
Latin American Cooperative Onco-Haematology Group - Peru
Conditions:
Mycosis Fungoides
Sezary Syndrome
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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...
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, followe...
Eligibility Criteria
Inclusion
- Above 18 years old
- Eastern Cooperative Oncology Group (ECOG) 0-2
- Liver and renal function test less than twice upper label
- No active infection
- Written informed consent
- One to three regimens of previous chemotherapies
Exclusion
- Abnormal renal or hepatic function
- Mycosis fungoides/Sezary syndrome in transformation
- HIV +
- HTLV-1 +
- Pregnancy
- Lactation
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
July 1 2008
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00157274
Start Date
July 1 2005
End Date
July 1 2008
Last Update
April 3 2007
Active Locations (1)
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1
Schering Peruana S.A.
Lima, Lima Province, Peru, 511