Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	18 to 75	Other	MF/SS NCT00157274

Trial Description

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.

Further Study Information

• 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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

Latin American Cooperative Onco-Haematology Group - Peru

Brady E Beltran, MD

Principal Investigator

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

Peru
	Lima
	Schering Peruana
		Jesus A Arones, MD	Ph: 99480078
			Email: alfredo_arones@hotmail.com

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00157274
Information obtained from ClinicalTrials.gov on March 18, 2009