Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

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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)

Trial contacts and locations

1

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Central trial contact

Julia M Huamani, MD

Data sourced from clinicaltrials.gov

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