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

NCT ID: NCT01400633

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 156 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2014-03-31

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.

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.

Conditions

Myelodysplastic Syndromes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

001

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

decitabine injection

Intervention Type: DRUG

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

Interventions

decitabine injection

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Korea, Ltd., Korea

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Korea, Ltd. Clinical Trial

Role: STUDY_DIRECTOR

Janssen Korea, Ltd.

Locations

Ansan, , South Korea

Anyang, , South Korea

Busan, , South Korea

Cheonan, , South Korea

Chungcheongbuk-Do, , South Korea

Daegu, , South Korea

Daejeon, , South Korea

Gyeonggi-do, , South Korea

Hwasun Gun, , South Korea

Incheon, , South Korea

Jinju, , South Korea

Jungnam, , South Korea

Kwanju, , South Korea

Pusan, , South Korea

Seoul, , South Korea

Suwon, , South Korea

Countries

South Korea

References

Jung KS, Kim YJ, Kim YK, Park SK, Kim HG, Kim SJ, Park J, Choi CW, Do YR, Kim I, Park S, Mun YC, Jeong SH, Kim MK, Yi HG, Chang MH, Kim SY, Lee JH, Jang JH. Clinical Outcomes of Decitabine Treatment for Patients With Lower-Risk Myelodysplastic Syndrome on the Basis of the International Prognostic Scoring System. Clin Lymphoma Myeloma Leuk. 2019 Oct;19(10):656-664. doi: 10.1016/j.clml.2019.06.003. Epub 2019 Jun 27.

Reference Type: DERIVED

PMID: 31375393 (View on PubMed)

Other Identifiers

DACOGENMDS4013

Identifier Type: OTHER

Identifier Source: secondary_id

Long-term treatment of Dacogen

Identifier Type: OTHER

Identifier Source: secondary_id

CR017842

Identifier Type: -

Identifier Source: org_study_id