A Study for Dacogen Treatment in Patients With Myelodysplastic Syndrome

NCT01041846 | Completed DMC

• 2 other identifiers: CR015895DECKOR5002
• Study Type: observational
• Target: 103
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Myelodysplastic Syndrome

Keywords

Myelodysplastic Syndrome; Dacogen; Decitabine; Epigenetic therapy; Hypomethylating agent

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• Number of patients with hematological improvement

  Up to 61 days

• 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

Secondary Outcomes (5)

• Cytogenetic response rate

  Up to 61 days

• Overall survival rate

  Up to 61 days

• Time to acute myeloid leukemia evolution

  Up to 61 days

• Number of patients with progression-free survival status

  Up to 61 days

• Number of patients with adverse event

  Up to 61 days

Study Arms (1)

Decitabine

Drug: No intervention

Interventions

No intervention DRUG

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.

Decitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Korea, Ltd., Korea: lead

Related Publications (2)

• 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.

  PMID: 31375393 DERIVED

• 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.

  PMID: 21659363 DERIVED

Related Links

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

MeSH Terms

Conditions

Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Janssen Korea, Ltd., Korea Clinical Trial

  Janssen Korea, Ltd., Korea

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2009
• First Posted: January 1, 2010
• Study Start: December 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 29, 2013

Record last verified: 2013-07