A 5 Day Course of Fludarabine and Cytarabine Followed by Full Intensity Allogeneic Stem Cell Transplantation (FA5-Bucy) in Treating Patients With High-risk, Recurrent or Refractory Acute Leukemia and Advanced Myelodysplastic Syndrome
NCT ID: NCT02328950
Last Updated: 2016-02-17
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
50 participants
OBSERVATIONAL
2014-12-31
2017-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide
Fludarabine (F) 30 mg/m²/day for 5 days (day -12 to day-8) Cytarabine (A) 2g/m²/day for 5 days (day -12 to day-8) Bulsufan (Bu) 0.8mg/kg/day for 3 days (day -7 to day-5) Cyclophosphamide(Cy) 1.8g/m²/day for 3 days (day -4 to day-3)
Eligibility Criteria
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Inclusion Criteria
* Aged between 0-65 years
* Patients suffering from either refractory de novo AML/ALL or relapsed AML/ALL or patients with very high risk AML/ALL in CR1
* Patients with advanced MDS
* Cardiac: Left ventricular ejection fraction ≥ 50%
* Adequate renal and hepatic function
* Performance status: Karnofsky ≥ 70%
Exclusion Criteria
* Current participation in another clinical trial
* Contra-indication to one of the drug of the regimen
* Any other severe concurrent disease, or have a history of serious organ dysfunction or disease involving the heart, kidney, liver or other organ system that may place the patient at undue risk to undergo the agents included in the conditioning regimen
1 Year
65 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Ting YANG
Prof. Dr.
Locations
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Union Hospital,Fujian Medical University
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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FA5Bucy-SCT-01
Identifier Type: -
Identifier Source: org_study_id
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