A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the effectiveness and safety of decitabine (Dacogen) intravenous injection in patients with Myelodysplastic Syndrome.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Korea, Ltd., Korea
• Treatments: Decitabine

Criteria

Inclusion Criteria:

Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including chronic myelomonocytic leukemia (CMML) with an International Prognostic Scoring System more than or equal to Interferon-1

• Patients who have never treated with hypomethylating agent (azacitidine and decitabine)

• Female patients who are postmenopausal or received contraceptive operation or refrain from sexual relations.

• Women of childbearing potential should conduct an effective method of birth control as defined in protocol, in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy

Exclusion Criteria:

• Patients diagnosed with acute myelogenous leukemia (bone marrow stem cell counts exceeding 20 %) or other progressive malignant diseases

• Patients with active infection of virus or bacteria

• Patients who used to be treated with azacitidine or decitabine

• Patients who are hypersensitive to excipients of decitabine

• Patients who are pregnant and breast-feeding