Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
Phase 2
- Conditions
- Mycosis FungoidesSezary Syndrome
- Registration Number
- NCT00157274
- Lead Sponsor
- Latin American Cooperative Onco-Haematology Group - Peru
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Event free survival Overall response Time to relapse
- Secondary Outcome Measures
Name Time Method Toxicity
Trial Locations
- Locations (1)
Schering Peruana S.A.
🇵🇪Lima, Peru