- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00157274
Study of Alemtuzumab to Treat Advanced Mycosis Fungoides/Sezary Syndrome
April 2, 2007 updated by: Latin American Cooperative Onco-Haematology Group - Peru
Phase II Study of Alemtuzumab in Patients With Advanced Mycosis Fungoides/Sezary Syndrome
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment
20
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Julia M Huamani, MD
- Phone Number: 511-2227020
- Email: juliahuamaniz@yahoo.es
Study Locations
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Lima, Peru, 511
- Recruiting
- Schering Peruana S.A.
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Contact:
- Jesus A Arones, MD
- Phone Number: 99480078
- Email: alfredo_arones@hotmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Overall response
|
Event free survival
|
Time to relapse
|
Secondary Outcome Measures
Outcome Measure |
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Toxicity
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Brady E Beltran, MD, LACOGH - PERU
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2005
Study Completion (Anticipated)
July 1, 2008
Study Registration Dates
First Submitted
September 7, 2005
First Submitted That Met QC Criteria
September 8, 2005
First Posted (Estimate)
September 12, 2005
Study Record Updates
Last Update Posted (Estimate)
April 3, 2007
Last Update Submitted That Met QC Criteria
April 2, 2007
Last Verified
September 1, 2005
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma, Non-Hodgkin
- Disease
- Bacterial Infections and Mycoses
- Lymphoma
- Lymphoma, T-Cell, Cutaneous
- Lymphoma, T-Cell
- Syndrome
- Mycoses
- Mycosis Fungoides
- Sezary Syndrome
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Alemtuzumab
Other Study ID Numbers
- MF/SS
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mycosis Fungoides
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)RecruitingRecurrent Mycosis Fungoides | Refractory Mycosis Fungoides | Stage I Mycosis Fungoides | Stage II Mycosis Fungoides | Stage III Mycosis FungoidesUnited States
-
National Cancer Institute (NCI)Active, not recruitingMycosis Fungoides | Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage III Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v8 | Recurrent Mycosis Fungoides... and other conditionsUnited States
-
Mayo ClinicNational Cancer Institute (NCI)Active, not recruitingMycosis Fungoides | Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage III Mycosis Fungoides... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Mycosis Fungoides and Sezary Syndrome | Refractory Mycosis Fungoides and Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIIA Mycosis... and other conditionsUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingSezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage II Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v8 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v8 | Transformed Mycosis Fungoides | Folliculotropic... and other conditionsUnited States
-
Northwestern UniversityAmgenTerminatedRecurrent Cutaneous T-cell Non-Hodgkin Lymphoma | Recurrent Mycosis Fungoides/Sezary Syndrome | Stage III Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IV Cutaneous T-cell Non-Hodgkin Lymphoma | Stage I Cutaneous T-cell Non-Hodgkin Lymphoma | Stage IA Mycosis Fungoides/Sezary Syndrome | Stage... and other conditionsUnited States
-
National Cancer Institute (NCI)CompletedRecurrent Mycosis Fungoides and Sezary Syndrome | Refractory Mycosis Fungoides and Sezary Syndrome | Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7 | Stage IIIA Mycosis... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...WithdrawnRecurrent Mycosis Fungoides and Sezary Syndrome | Cutaneous T-Cell Non-Hodgkin Lymphoma | Stage IIB Mycosis Fungoides and Sezary Syndrome | Stage IIIA Mycosis Fungoides and Sezary Syndrome | Stage IIIB Mycosis Fungoides and Sezary Syndrome | Stage IVA Mycosis Fungoides and Sezary Syndrome | Stage...
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Rochester Skin Lymphoma Medical Group, PLLCRochester General HospitalCompletedMycosis Fungoides | Cutaneous T-cell Lymphoma | Transformed Mycosis Fungoides | Cutaneous T-cell Lymphoma Stage I | Folliculotropic Mycosis Fungoides | Granulomatous Slack Skin | Syringotropic Mycosis Fungoides | Mycosis Fungoides VariantUnited States
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Memorial Sloan Kettering Cancer CenterRecruitingMycosis Fungoides | Sezary Syndrome | Mycosis Fungoides/Sezary Syndrome | Sézary | Advanced Mycosis FungoidesUnited States
Clinical Trials on alemtuzumab
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German CLL Study GroupCompletedChronic Lymphocytic LeukemiaGermany
-
Case Comprehensive Cancer CenterNational Cancer Institute (NCI); Genzyme, a Sanofi CompanyCompleted
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Genzyme, a Sanofi CompanyTerminatedNon-Hodgkins LymphomaUnited States
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)WithdrawnLymphomaUnited States, Australia, United Kingdom, Canada, France
-
Karolinska University HospitalSchering Nordiska ABCompleted
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Genzyme, a Sanofi CompanyTerminatedHematologic MalignanciesUnited States
-
Genzyme, a Sanofi CompanyCompletedB Cell Chronic Lymphocytic LeukemiaUnited States
-
German CLL Study GroupCompleted
-
University Hospital MuensterUnknown
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University of AlbertaJuvenile Diabetes Research FoundationCompleted