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Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

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ClinicalTrials.gov Identifier: NCT00157274
Recruitment Status : Unknown
Verified September 2005 by Latin American Cooperative Onco-Haematology Group - Peru.
Recruitment status was:  Recruiting
First Posted : September 12, 2005
Last Update Posted : April 3, 2007
Sponsor:
Information provided by:
Latin American Cooperative Onco-Haematology Group - Peru

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.

Condition or disease Intervention/treatment Phase
Mycosis Fungoides Sezary Syndrome Drug: alemtuzumab Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
Study Start Date : July 2005
Estimated Study Completion Date : July 2008





Primary Outcome Measures :
  1. Overall response
  2. Time to relapse
  3. Event free survival

Secondary Outcome Measures :
  1. Toxicity


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications of Results:
ClinicalTrials.gov Identifier: NCT00157274     History of Changes
Other Study ID Numbers: MF/SS
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: April 3, 2007
Last Verified: September 2005

Keywords provided by Latin American Cooperative Onco-Haematology Group - Peru:
Alemtuzumab
Mycosis fungoides
Sezary

Additional relevant MeSH terms:
Syndrome
Mycoses
Mycosis Fungoides
Sezary Syndrome
Disease
Pathologic Processes
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Alemtuzumab
Antineoplastic Agents