Evaluating the Safety and Effectiveness of Decitabine in People With Thalassemia Intermedia

Completed · Phase 2

Conditions studied: Thalassemia

In brief

Thalassemia intermedia (TI) is an inherited blood disorder that can cause anemia due to low levels of hemoglobin. Decitabine is a medication that may be effective at increasing hemoglobin levels. This study will evaluate the safety and effectiveness of decitabine at increasing hemoglobin levels in people with TI.

Key facts

Study ID

NCT00661726

Run by

Carelon Research

People needed

6

Starts

2008-01-01

Expected to finish

2010-09-01

Last updated by the study team

2014-04-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Beta-thalassemia and beta thalassemia-hemoglobin E (HbE), as confirmed by DNA testing
• Transfusion independent for at least 120 days before study entry
• Red blood cell folate levels above the lower limit of normal

You may not qualify if…

• Absolute neutrophil count (ANC) less than 2000/mm3 in the 8 weeks before study entry or a history of chronic neutropenia, defined as an ANC less than 2000/mm3
• Platelet count less than 100,000/mm3 or greater than 1,000,000/mm3 in the 8 weeks before study entry
• Family history of an inherited disease resulting in low ANC or bone marrow failure
• Serum creatinine level greater than 2 mg/dL in the 8 weeks before study entry
• Evidence of liver disease, as defined by one or more of the following conditions:
• Alanine aminotransferase (ALT) level greater than 3 times the upper limit of normal in the 8 weeks before study entry
• Serum albumin level less than 3 g/dL in the 8 weeks before study entry
• Evidence of cirrhosis on liver biopsy obtained in the 6 months before study entry
• Approaching death; has concurrent liver, kidney, cardiac, or metabolic disease; or has any disease of such severity that death within 7 to 10 days of study entry is likely
• Pregnant, planning to become pregnant, or breastfeeding
• Sexually active female of childbearing potential who is unwilling to use at least two acceptable methods of contraception, as determined by the investigator
• Sexually active male whose partner is of child-bearing potential and who is unwilling to use at least two acceptable methods of contraception, as determined by the investigator, during and for 2 months after decitabine treatment
• Diagnosed with cancer (except non-melanoma skin cancer) in the 5 years before study entry. In particular, suspicion or evidence of myelodysplastic syndrome (MDS) on clinically indicated bone marrow aspirate or a family history of MDS or concurrent leukemia
• HIV infection
• Not expected to be able to complete 24 weeks of study follow-up
• Currently being treated with any experimental or fetal hemoglobin modulating agent
• Current participation in any other studies of investigational drugs or devices
• Unable to comply with study medication regimen
• Any condition, which in the opinion of the investigator, would place the individual at undue risk if treated with twice-weekly low-dose decitabine for 12 weeks

Where it is running

• Children's Hospital and Research Center at Oakland — Oakland, California, United States
• Children's Hospital Philadelphia — Philadelphia, Pennsylvania, United States
• University Health Network — Toronto, Canada

Full record on ClinicalTrials.gov

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