A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

Completed

• Conditions: Myelodysplastic Syndrome
• Interventions: Drug: No intervention

• Registration Number: NCT01041846
• Lead Sponsor: Janssen Korea, Ltd., Korea

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-30
• Study First Posted: 2010-01-01
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-26
• Last Update Posted: 2013-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Decitabine	No intervention	-

Primary Outcome Measures

Name	Time	Method
Number of patients with complete remission	Up to 61 days	The complete response includes the evaluations of Bone marrow aspiration and biopsy (less than or equal to 5 percents myeloblast), persistent dysplasia and peripheral blood.
Number of patients with partial remission	Up to 61 days	The partial response includes all complete remission evaluating parameters with the exception of bone marrow blasts are decreased by more than or equal to 50 percents over pretreatment but still more than 5 percents and cellularity (the state of a tissue or other mass as regards the number of its constituent cells) and morphology (examination of structure)
Number of patients with hematological improvement	Up to 61 days
Response rate	After 4 cycles and end of treatment	Response rate is the combination of complete remission, partial remission and hematological improvement and performed according to the response criteria of 'International Working Group 2006' which is standardized criteria for assessing response are essential to ensure comparability among clinical trials for patients with MDS.

Secondary Outcome Measures

Name	Time	Method
Cytogenetic response rate	Up to 61 days
Overall survival rate	Up to 61 days	Overall survival will be evaluated from the registration day to death.
Time to acute myeloid leukemia evolution	Up to 61 days	The time of progression from myelodysplastic syndromes to acute myeloid leukemia.
Number of patients with progression-free survival status	Up to 61 days	Hospitalization or undergoes surgical procedure due to disease progression.
Number of patients with adverse event	Up to 61 days