Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

Latin American Cooperative Onco-Haematology Group - Peru

Status and phase: Unknown; Phase 2

Conditions: Mycosis Fungoides; Sezary Syndrome

Treatments: Drug: alemtuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT00157274

MF/SS

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)