Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome - Full Text View

Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

This study is currently recruiting participants.
Verified by Latin American Cooperative Onco-Haematology Group - Peru, September 2005

Sponsored by:	Latin American Cooperative Onco-Haematology Group - Peru
Information provided by:	Latin American Cooperative Onco-Haematology Group - Peru
ClinicalTrials.gov Identifier:	NCT00157274

Purpose

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.

Condition	Intervention	Phase
Mycosis Fungoides Sezary Syndrome	Drug: alemtuzumab	Phase II

MedlinePlus related topics:

Fungal Infections

ChemIDplus related topics:

Alemtuzumab Campath

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study

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

Further study details as provided by Latin American Cooperative Onco-Haematology Group - Peru:

Primary Outcome Measures:

Overall response
Time to relapse
Event free survival

Secondary Outcome Measures:

Toxicity

Estimated Enrollment:	20
Study Start Date:	July 2005
Estimated Study Completion Date:	July 2008

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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00157274

Contacts


Contact: Julia M Huamani, MD	511-2227020	juliahuamaniz@yahoo.es

Locations


Peru
	Schering Peruana S.A.	Recruiting
	Lima, Peru, 511
	Contact: Jesus A Arones, MD 99480078 alfredo_arones@hotmail.com

Sponsors and Collaborators

Latin American Cooperative Onco-Haematology Group - Peru

Investigators


Principal Investigator:	Brady E Beltran, MD	LACOGH - PERU

More Information

Publications of Results:

Lundin J, Hagberg H, Repp R, Cavallin-Stahl E, Freden S, Juliusson G, Rosenblad E, Tjonnfjord G, Wiklund T, Osterborg A. Phase 2 study of alemtuzumab (anti-CD52 monoclonal antibody) in patients with advanced mycosis fungoides/Sezary syndrome. Blood. 2003 Jun 1;101(11):4267-72. Epub 2003 Jan 23.

Study ID Numbers:	MF/SS
First Received:	September 7, 2005
Last Updated:	April 2, 2007
ClinicalTrials.gov Identifier:	NCT00157274
Health Authority:	Peru: General Directorate of Pharmaceuticals, Devices, and Drugs

Keywords provided by Latin American Cooperative Onco-Haematology Group - Peru:

Alemtuzumab

Mycosis fungoides

Sezary

Study placed in the following topic categories:

Sezary syndrome

Immunoproliferative Disorders

Cutaneous T-cell lymphoma

Sezary Syndrome

Mycosis Fungoides

Mycoses

Lymphatic Diseases

Lymphoma, T-Cell

Alemtuzumab

Lymphoma, Non-Hodgkin

Lymphoproliferative Disorders

Lymphoma

Lymphoma, T-Cell, Cutaneous

Additional relevant MeSH terms:

Neoplasms

Pathologic Processes

Disease

Neoplasms by Histologic Type

Immune System Diseases

Antineoplastic Agents

Therapeutic Uses

Syndrome

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 10, 2008