Trial | NCT00157274  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
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.
Study Started
Jul 31
2005
Study Completion
Jul 31
2008
Anticipated
Last Update
Apr 03
2007
Estimate

Drug 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
No Results Posted