Effects of Antithymocyte Globulin in Adults With Myelodysplastic Syndrome

• Status: Unknown status
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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 the effects of the medication antithymocyte globulin (ATG) in adults with MDS and to determine which individuals with MDS are most likely to benefit from treatment with ATG.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Office of Rare Diseases (ORD)
• Collaborator: Rare Diseases Clinical Research Network
• Treatments: Antilymphocyte Serum; Prednisone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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