Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT
NCT ID: NCT04216355
Last Updated: 2020-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2020-01-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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AZA with CAG derived regimen
Azacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC)
Azacitidine
Low-dose AZA
CAG Protocol
Short term CAG derived regimen
Interventions
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Azacitidine
Low-dose AZA
CAG Protocol
Short term CAG derived regimen
Eligibility Criteria
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Inclusion Criteria
* Recipient of an allogeneic hematopoietic stem cell transplantation
* Age \< 65 years
* ECOG performance status ≤2
* Written informed consent
* No psychological, familial, social, or geographic reason that would compromise clinical follow up
Exclusion Criteria
* Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment
* Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials
* Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk
* A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications
65 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Ting YANG
Principal Investigator
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MDS-SCT-01
Identifier Type: -
Identifier Source: org_study_id
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