Clinical trial NCT01041846: A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
Official title: A Prospective Multicenter Observational Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome
Dacogen
Decitabine
Epigenetic therapy
Hypomethylating agent
Lead sponsor: Janssen Korea, Ltd., Korea
Sponsor class: INDUSTRY
First posted: 2010-01-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients who signed the subject informed consent form among the patients with myelodysplastic syndrome who were treated with decitabine

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with complete remission
timeFrame: Up to 61 days
measure: Number of patients with partial remission
timeFrame: Up to 61 days
measure: Number of patients with hematological improvement
timeFrame: Up to 61 days
measure: Response rate
timeFrame: After 4 cycles and end of treatment
Secondary outcomes:
measure: Cytogenetic response rate
timeFrame: Up to 61 days
measure: Overall survival rate
timeFrame: Up to 61 days
measure: Time to acute myeloid leukemia evolution
timeFrame: Up to 61 days
measure: Number of patients with progression-free survival status
timeFrame: Up to 61 days
measure: Number of patients with adverse event
timeFrame: Up to 61 days
Other outcomes:
Locations:
Study officials:
affiliation: Janssen Korea, Ltd., Korea
name: Janssen Korea, Ltd., Korea Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Lee JH, Jang JH, Park J, Park S, Joo YD, Kim YK, Kim HG, Choi CW, Kim SH, Park SK, Park E, Min YH. A prospective multicenter observational study of decitabine treatment in Korean patients with myelodysplastic syndrome. Haematologica. 2011 Oct;96(10):1441-7. doi: 10.3324/haematol.2011.046078. Epub 2011 Jun 9.