Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation (DFMBHSCT)
Primary Purpose
Higher-risk Myelodysplastic Syndrome, Relapsed /Refractory Acute Myeloid Leukemia
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
decitabine
Sponsored by
About this trial
This is an interventional treatment trial for Higher-risk Myelodysplastic Syndrome focused on measuring myelodysplastic syndrome, higher-risk, acute myeloid leukemia, relapsed /refractory, decitabine, hematopoietic cell transplantation, bridge therapy
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
decitabine + transplantation
Arm Description
Outcomes
Primary Outcome Measures
overall survival rates
Secondary Outcome Measures
disease free survival
Full Information
NCT ID
NCT01806116
First Posted
March 5, 2013
Last Updated
March 11, 2013
Sponsor
The First Affiliated Hospital of Soochow University
1. Study Identification
Unique Protocol Identification Number
NCT01806116
Brief Title
Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
Acronym
DFMBHSCT
Official Title
Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital of Soochow University
4. Oversight
5. Study Description
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 cause for treatment failure after hematopoietic cell transplantation (HCT) in patients,so that there is the need to continue to look for alternative therapies. Decitabine, is known to inhibit DNA methyltransferase which results in DNA hypomethylation and expression of silenced genes including those involved in apoptosis. The approval of decitabine for the treatment of MDS and AML has provided an alternative strategy to inhibit disease progression in transplant-eligible patients. To assess the effect of pretransplant decitabine treatment on post transplant outcomes, we recently reviewed our institutional experience with MDS and AML patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Higher-risk Myelodysplastic Syndrome, Relapsed /Refractory Acute Myeloid Leukemia
Keywords
myelodysplastic syndrome, higher-risk, acute myeloid leukemia, relapsed /refractory, decitabine, hematopoietic cell transplantation, bridge therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
decitabine + transplantation
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
decitabine
Primary Outcome Measure Information:
Title
overall survival rates
Time Frame
three years
Secondary Outcome Measure Information:
Title
disease free survival
Time Frame
three years
Other Pre-specified Outcome Measures:
Title
The incidences of acute and chronic graft-versus-host disease
Time Frame
three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wu depei, Phd
Organizational Affiliation
First Affiliated Hospital, Soochow University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Decitabine for Myelodysplastic Syndromes and Acute Myeloid Leukemia Before Allogeneic Hematopoietic Cell Transplantation
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