An Observational Study for Dacogen Long-Term Treatment in Patients With Myelodysplastic Syndrome

Sponsor

Janssen Korea, Ltd., Korea (Industry)

Overall Status

Completed

CT.gov ID

NCT01400633

Collaborator

(none)

156

Enrollment

Locations

Duration (Months)

9.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to investigate the overall response rate (ORR) and safety when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as there is evidence of clinical benefit.

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic Syndromes	Drug: decitabine injection

Detailed Description

This study is a prospective (the study follows a group of individuals over time), open label (all people involved know the identity of the intervention), multicenter, single arm (one group of patients receiving the same treatment), observational study to observe the response rate and safety of decitabine when treating patients with myelodysplastic syndrome with decitabine. Decitabine is to be administered as long as there is evidence of clinical benefit. It will be assessed if the treatment duration could be prolonged by appropriate toxicity management such as an active antibiotic prophylaxis or dose and schedule modification, and whether this leads to potentially increased clinical benefits such as higher response rate, longer time to Acute Myeloid Leukemia, and prolonged overall survival. For safety evaluation, adverse events and peripheral blood findings will be collected. The patient will receive decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks.

Study Design

Study Type:

Observational

Actual Enrollment :

156 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Dec 1, 2010

Actual Primary Completion Date :

Mar 1, 2014

Actual Study Completion Date :

Mar 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
001 decitabine injection decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks	Drug: decitabine injection decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks

Arm

Intervention/Treatment

001

decitabine injection decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks

Drug: decitabine injection

decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks

Outcome Measures

Primary Outcome Measures

overall response rate [every 28 days up to approximately 5 years]

Secondary Outcome Measures

The change of transfusion requirements [every 4 weeks up to approximately 5 years]
Overall survival [every 3 months up to approximately 5 years]
Adverse events [every 4 weeks up to approximately 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients diagnosed with (primary or secondary) Myelodysplastic Syndrome including Chronic Myelomonocytic Leukemia (CMML)
Patients with an International Prognostic Scoring System >= Int-1
Patients who were 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 (oral contraceptives, injections, intrauterine device, double barrier method, contraceptive patch and male partner's sterilization), in case of male patients who will not have a baby within 2 months after the completion of decitabine therapy
Patients who signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study.

Exclusion Criteria:

Patients diagnosed with Acute Myelogenous Leukemia (AML, 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 or breast-feeding.

Contacts and Locations

Locations

	City	Country
1	Ansan	Korea, Republic of
2	Anyang	Korea, Republic of
3	Busan	Korea, Republic of
4	Cheonan	Korea, Republic of
5	Chungcheongbuk-Do	Korea, Republic of
6	Chungnam	Korea, Republic of
7	Daegu	Korea, Republic of
8	Daejeon	Korea, Republic of
9	Gyeonggi-Do	Korea, Republic of
10	Hwasun Gun	Korea, Republic of
11	Incheon	Korea, Republic of
12	Jinju-Si	Korea, Republic of
13	Kwanju	Korea, Republic of
14	Pusan	Korea, Republic of
15	Seoul	Korea, Republic of
16	Suwon	Korea, Republic of