Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

Mycosis Fungoides Clinical Trial

Official title:

Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00157274
• Other study ID #: MF/SS
• Status: Recruiting
• Phase: Phase 2
• First received: September 7, 2005
• Last updated: April 2, 2007
• Start date: July 2005
• Est. completion date: July 2008

Study information

• Verified date: September 2005
• Source: Latin American Cooperative Onco-Haematology Group - Peru
• Contact: Julia M Huamani, MD
• Phone: 511-2227020
• Email: juliahuamaniz[@]yahoo.es
• Is FDA regulated: No
• Health authority: Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Mycoses
• Mycosis Fungoides
• Sezary Syndrome
• Syndrome

Intervention

Drug:
• alemtuzumab

Locations

Country	Name	City	State
Peru	Schering Peruana S.A.	Lima

Sponsors (1)

Lead Sponsor	Collaborator
Latin American Cooperative Onco-Haematology Group - Peru

Country where clinical trial is conducted

Peru, 

References & Publications (1)

Lundin J, Hagberg H, Repp R, Cavallin-Ståhl E, Fredén S, Juliusson G, Rosenblad E, Tjønnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response
Primary	Time to relapse
Primary	Event free survival
Secondary	Toxicity