Status:
UNKNOWN
Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
Higher-risk Myelodysplastic Syndrome
Relapsed /Refractory Acute Myeloid Leukemia
Eligibility:
All Genders
8-65 years
Phase:
PHASE4
Brief Summary
Allogeneic stem cell transplantation (SCT) is the only potentially curative therapy for patients with myelodysplastic syndrome (MDS) and acute myeloblastic leukemia (AML). Relapse remains a leading ca...
Eligibility Criteria
Inclusion
- Age 8- 65 years
- Diseases must be myelodysplastic syndrome and acute myelocytic leukemia
- Must need a bone marrow transplant
- Must have the ability to observe the efficacy and events
- Patient must have ability to understand and willingness to provide written informed consent prior to participation in the study and any related procedures being performed
Exclusion
- Must not have uncontrolled intercurrent illness including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements
- Must not be pregnant or breastfeeding; pregnant women are excluded from this study because decitabine is a Category D agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with decitabine, breastfeeding should be discontinued if the mother is treated with decitabine; these potential risks may also apply to other agents used in this study
- Must not have a known or suspected hypersensitivity to decitabine
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01806116
Start Date
September 1 2009
End Date
May 1 2014
Last Update
March 12 2013
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