Overview

Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

Status:
Unknown status
Trial end date:
2008-07-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Latin American Cooperative Onco-Haematology Group - Peru
Treatments:
Alemtuzumab
Criteria
Inclusion Criteria:

- 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 Criteria:

- Abnormal renal or hepatic function

- Mycosis fungoides/Sezary syndrome in transformation

- HIV +

- HTLV-1 +

- Pregnancy

- Lactation