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Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Latin American Cooperative Onco-Haematology Group - Peru.
Recruitment status was:  Recruiting
Information provided by:
Latin American Cooperative Onco-Haematology Group - Peru Identifier:
First received: September 7, 2005
Last updated: April 2, 2007
Last verified: September 2005
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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

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.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00157274

Contact: Julia M Huamani, MD 511-2227020

Schering Peruana S.A. Recruiting
Lima, Peru, 511
Contact: Jesus A Arones, MD    99480078   
Sponsors and Collaborators
Latin American Cooperative Onco-Haematology Group - Peru
Principal Investigator: Brady E Beltran, MD LACOGH - PERU
  More Information

Publications: Identifier: NCT00157274     History of Changes
Other Study ID Numbers: MF/SS
Study First Received: September 7, 2005
Last Updated: April 2, 2007

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

Additional relevant MeSH terms:
Mycosis Fungoides
Sezary Syndrome
Pathologic Processes
Lymphoma, T-Cell, Cutaneous
Lymphoma, T-Cell
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antineoplastic Agents processed this record on September 21, 2017