A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

Janssen (J&J Innovative Medicine)

Status: Completed

Conditions: Myelodysplastic Syndrome

Treatments: Drug: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT01041846

DECKOR5002 (Other Identifier)

CR015895

Details and patient eligibility

About

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

Full description

This is a prospective (in which the patients are first identified and then followed forward as time passes), multi-center (study conducted at multiple sites), observational study (a scientific study to make a clear and easy understanding of the cause and effect relationship) to evaluate the effectiveness and safety information of a 5 day decitabine (Dacogen) regimen in patients with Myelodysplastic Syndrome. This study consist of 3 phases; pre-treatment phase, treatment phase and end of treatment (Day 28~61 after last administration of Dacogen). The patients will receive decitabine intravenous injection 20 mg/m2 one hour once daily for 5 consecutive days for every 4 weeks. Safety evaluations including adverse events and clinical laboratory tests and will be evaluated with adverse events reported for the period ranging from informed consent and during the study to the end of treatment visit including 56 days (8 weeks) after the last administration of the clinical study treatment.

Enrollment: 103 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

103 participants in 1 patient group

Decitabine

Treatment:

Drug: No intervention