Microtransplantation With Decitabine and Cytarabine Improves Patient Outcomes in Myelodysplastic Syndromes
1 other identifier
interventional
43
1 country
1
Brief Summary
The purpose of this study is to investigate whether infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC) combining decitabine and cytarabine chemotherapy can improve outcomes in myelodysplastic syndromes (MDS) patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Sep 2009
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 25, 2012
CompletedFirst Posted
Study publicly available on registry
August 29, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedJuly 13, 2016
July 1, 2016
4.1 years
August 25, 2012
July 12, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
complete remission
six months
Secondary Outcomes (1)
disease-free survival
three years
Other Outcomes (1)
overall survival
three years
Study Arms (1)
Decitabine and cytarabine
EXPERIMENTALinduction therapy：decitabine 25mg/m2 daily for 4 days with cytarabine 150 mg/m2 daily for 7 days consolidation：decitabine 25mg/m2 daily for 4 days with cytarabine 2g/m2 q12h for 3 days
Interventions
Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)
Eligibility Criteria
You may qualify if:
- patients 10 to 90 years old with primary or treatment-related MDS or chronic myelomonocytic leukemia;
- International Prognostic Scoring System(IPSS) intermediate-1,intermediate-2,or high risk;
- bone marrow blasts \> 11% or \<= 10% and poor cytogenetics;
- lack of an HLA-identical donor;
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
- adequate cardiac and hepatorenal functions.
You may not qualify if:
- have an HLA-identical donor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Affiliated Hospital of Academy of Military Medical Sciences
Beijing, Beijing Municipality, 100071, China
Related Publications (1)
Guo M, Hu KX, Yu CL, Sun QY, Qiao JH, Wang DH, Liu GX, Sun WJ, Wei L, Sun XD, Huang YJ, Qiao JX, Dong Z, Ai HS. Infusion of HLA-mismatched peripheral blood stem cells improves the outcome of chemotherapy for acute myeloid leukemia in elderly patients. Blood. 2011 Jan 20;117(3):936-41. doi: 10.1182/blood-2010-06-288506. Epub 2010 Oct 21.
PMID: 20966170BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sheng Hui Ai, M.D
Affiliated Hospital of Academy of Military Medical Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2012
First Posted
August 29, 2012
Study Start
September 1, 2009
Primary Completion
October 1, 2013
Study Completion
December 1, 2015
Last Updated
July 13, 2016
Record last verified: 2016-07