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)