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

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

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.

Study Overview

• Status: Completed
• Conditions: Myelodysplastic Syndromes
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 156

Contacts and Locations

Study Locations

• Korea, Republic of
  • Ansan, Korea, Republic of
  • Anyang, Korea, Republic of
  • Busan, Korea, Republic of
  • Cheonan, Korea, Republic of
  • Chungcheongbuk-Do, Korea, Republic of
  • Chungnam, Korea, Republic of
  • Daegu, Korea, Republic of
  • Daejeon, Korea, Republic of
  • Gyeonggi-Do, Korea, Republic of
  • Hwasun Gun, Korea, Republic of
  • Incheon, Korea, Republic of
  • Jinju-Si, Korea, Republic of
  • Kwanju, Korea, Republic of
  • Pusan, Korea, Republic of
  • Seoul, Korea, Republic of
  • Suwon, Korea, Republic of

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Secondary or tertiary hospitals in South Korea

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall response rate	every 28 days up to approximately 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Janssen Korea, Ltd., Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2014
• Study Completion (Actual): March 1, 2014

Study Registration Dates

• First Submitted: July 14, 2011
• First Submitted That Met QC Criteria: July 21, 2011
• First Posted (Estimate): July 22, 2011

Study Record Updates

• Last Update Posted (Estimate): May 25, 2015
• Last Update Submitted That Met QC Criteria: May 22, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Dacogen; Myelodysplastic Syndrome; decitabine; hypomethylating agent; epigenetic therapy
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Disease; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Syndrome; Myelodysplastic Syndromes; Preleukemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Decitabine
• Other Study ID Numbers: CR017842; DACOGENMDS4013 (Other Identifier: Janssen Korea, Ltd., Korea); Long-term treatment of Dacogen (Other Identifier: Janssen Korea, Ltd., Korea)