Mycosis Fungoides, Sezary Syndrome
Conditions
Keywords
Alemtuzumab, Mycosis fungoides, Sezary
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.
Interventions
DRUGalemtuzumab
Sponsors
Latin American Cooperative Onco-Haematology Group - Peru
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response | — |
| Time to relapse | — |
| Event free survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity | — |
Countries
Peru
Contacts
Primary ContactJulia M Huamani, MD
Outcome results
None listed