A Phase 2 interventional study of Decitabine in Myelodysplastic Syndrome, sponsored by Eisai Inc.. Completed at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-05-20.
Sponsored by Eisai Inc. · Phase 2, Interventional, and Treatment
The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.
1,317 studies on the registry are indexed under Preleukemia; 57 are open to participants now.
This study's enrollment of 99 is above the median of 36 across 1,060 interventional studies indexed under Preleukemia.
Browse Preleukemia studies →Eisai Inc. is the lead sponsor of 360 studies on the registry; 7 are open to participants now.
Of its 81 completed or terminated interventional studies of FDA-regulated products, 54 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Decitabine
20mg/m\^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.
Also known as: Dacogen
Number of Participants Who Achieved Overall Response
Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)
Time frame: 1 year
Best Response and Overall Improvement
Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)
Time frame: 1 year
| Milestone | Decitabine 20 mg/m2 Intravenous |
|---|---|
| Started | 99 |
| Completed | 6 |
| Not completed | 93 |
| Withdrew: Progressive disease | 22 |
| Withdrew: Adverse event | 17 |
| Withdrew: Death | 13 |
| Withdrew: Withdrawal by subject | 13 |
| Withdrew: Physician decision | 19 |
| Withdrew: Not otherwise specified | 8 |
| Withdrew: Medication noncompliance | 1 |
Overall Response = complete remission (disappearance of all target lesions) + partial remission (at least 30% decrease in the sum of the longest diameters of target lesions)
| participants | Decitabine 20 mg/m2 Intravenous |
|---|---|
| Number of Participants Who Achieved Overall Response | 33 |
Overall Improvement = complete remission + marrow complete remission + partial remission + hematologic improvement (CR+mCR+PR+HI)
| Participants | Decitabine 20 mg/m2 Intravenous |
|---|---|
| Overall Improvement | 51 |
| Complete Remission (CR) | 17 |
| Marrow Complete Remission (mCR) | 16 |
| Partial Remission (PR) | 0 |
| Hematologic Improvement (HI) | 18 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Decitabine 20 mg/m2 Intravenous | — | 65/99 (65.7%) | 96/99 (97%) |
| Event | Decitabine 20 mg/m2 Intravenous |
|---|---|
| PneumoniaInfections and infestations | 17/99 |
| Febrile NeutropeniaBlood and lymphatic system disorders | 13/99 |
| NeutropeniaBlood and lymphatic system disorders | 12/99 |
| AnaemiaBlood and lymphatic system disorders | 9/99 |
| Staphylococcal BacteraemiaInfections and infestations | 7/99 |
| PyrexiaGeneral disorders | 6/99 |
| PancytopeniaBlood and lymphatic system disorders | 4/99 |
| Disease ProgressionGeneral disorders | 4/99 |
| SepsisInfections and infestations | 4/99 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 4/99 |
| Event | Decitabine 20 mg/m2 Intravenous |
|---|---|
| FatigueGeneral disorders | 46/99 |
| NauseaGastrointestinal disorders | 40/99 |
| NeutropeniaBlood and lymphatic system disorders | 38/99 |
| PyrexiaGeneral disorders | 36/99 |
| AnaemiaBlood and lymphatic system disorders | 31/99 |
| ConstipationGastrointestinal disorders | 30/99 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 29/99 |
| DiarrheaGastrointestinal disorders | 28/99 |
| ThrombocytopeniaBlood and lymphatic system disorders | 27/99 |
| Oedema PeripheralGeneral disorders | 27/99 |
| Age, Categorical(Participants) | Decitabine 20 mg/m2 Intravenous |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 15 |
| >=65 years | 84 |
| Age Continuous(years) | Decitabine 20 mg/m2 Intravenous |
|---|---|
| Mean | 70.9 ± 8.78 |
| Sex: Female, Male(Participants) | Decitabine 20 mg/m2 Intravenous |
|---|---|
| Female | 28 |
| Male | 71 |
| Race (NIH/OMB)(Participants) | Decitabine 20 mg/m2 Intravenous |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 4 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 6 |
| White | 86 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
| Region of Enrollment(participants) | Decitabine 20 mg/m2 Intravenous |
|---|---|
| United States | 99 |
This study is completed, as verified in Jun 2010. You cannot join it, but the record below documents what was studied.
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Eisai Inc.