Status:
UNKNOWN
Effects of Antithymocyte Globulin in Adults With Myelodysplastic Syndrome
Lead Sponsor:
Office of Rare Diseases (ORD)
Collaborating Sponsors:
Rare Diseases Clinical Research Network
Conditions:
Myelodysplastic Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Myelodysplastic syndrome (MDS) is a rare, potentially serious bone marrow disease. Currently available treatments for MDS have been only somewhat beneficial. The purpose of this study is to determine ...
Detailed Description
In people with MDS, the bone marrow stops making healthy blood cells and instead produces poorly functioning, malformed, and immature blood cells. This can lead to anemia resulting from too few health...
Eligibility Criteria
Inclusion
- Diagnosis of MDS that meets International Prognostic Scoring System (IPSS) criteria for low risk, intermediate-1 risk, or intermediate-2 risk. More information about this criterion can be found in the protocol.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
- Willing and able to attend study visits
- Willing to use acceptable forms of contraception prior to study entry and for the duration of the study
Exclusion
- Any serious medical illness that might limit survival to less than 2 years
- Any other uncontrolled condition or illness. More information about this criterion can be found in the protocol.
- Prior anti-lymphocyte serotherapy (received serum from an immunized animal)
- Proliferative chronic myelomonocytic leukemia
- MDS that is caused by radiotherapy, chemotherapy, and/or immunotherapy for cancerous or autoimmune diseases
- Previous or current cancer. More information about this criterion can be found in the protocol.
- Receiving any other investigational agents
- Certain abnormal lab values. More information about this criterion can be found in the protocol.
- History of a grade 2 National Cancer Institute common toxic criteria allergic reaction to rabbit proteins
- Psychiatric illness that might interfere with study participation
- HIV-1 infection
- Pregnancy or breastfeeding
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00466843
Start Date
April 1 2007
End Date
February 1 2010
Last Update
June 2 2009
Active Locations (4)
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1
UCLA Oncology Center
Los Angeles, California, United States, 90095
2
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
3
Cleveland Clinic Foundation - Case Western University
Cleveland, Ohio, United States, 44195
4
Penn State University
Hershey, Pennsylvania, United States, 17033