A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

Myelodysplastic Syndrome Clinical Trial

Official title:

A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01041846
• Other study ID #: CR015895
• Secondary ID: DECKOR5002
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2009
• Last updated: July 26, 2013
• Start date: December 2008
• Est. completion date: July 2010

Study information

• Verified date: July 2013
• Source: Janssen Korea, Ltd., Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Myelodysplastic Syndrome
• Myelodysplastic Syndromes
• Preleukemia
• Syndrome

Intervention

Drug:
• No intervention
This is an observational study. Patients receiving 20 mg/m2 of decitabine injection intravenously (into a vein) once daily for 5 days every 4 weeks will be observed.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Korea, Ltd., Korea

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with complete remission	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.	Up to 61 days	No
Primary	Number of patients with partial remission	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)	Up to 61 days	No
Primary	Number of patients with hematological improvement		Up to 61 days	No
Primary	Response rate	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.	After 4 cycles and end of treatment	No
Secondary	Cytogenetic response rate		Up to 61 days	No
Secondary	Overall survival rate	Overall survival will be evaluated from the registration day to death.	Up to 61 days	No
Secondary	Time to acute myeloid leukemia evolution	The time of progression from myelodysplastic syndromes to acute myeloid leukemia.	Up to 61 days	No
Secondary	Number of patients with progression-free survival status	Hospitalization or undergoes surgical procedure due to disease progression.	Up to 61 days	No
Secondary	Number of patients with adverse event		Up to 61 days	Yes

External Links

•   A Prospective, Multicenter, Observational Study of Dacogen Treatment in Patients with Myelodysplastic Syndrome