AML1-ETO Acute Myeloid Leukemia With Fludarabine and Cytarabine Chemotherapy
NCT ID: NCT02024308
Last Updated: 2013-12-31
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
PHASE4
62 participants
INTERVENTIONAL
2010-11-30
2016-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Fludarabine
The patients in experimental arm should receive the consolidation chemotherapy regimen with fludarabine and cytarabine. The dosage of fludarabine is 30mg/m2/d for 5 days intravenously and cytarabine is 1.4g/m2/d for 5 days intravenously.
Fludarabine
50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4
Cytarabine
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
HD-Arac
The patients in control arm should receive the consolidation chemotherapy regimen with high-dose cytarabine. The dosage of cytarabine is 2000mg/m2/12h for 3 days (1,3,5) intravenously.
Cytarabine
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
Interventions
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Fludarabine
50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4
Cytarabine
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* In status of complete remission after one to two courses of induction therapy with DA(Daunorubicin 60mg/m2/d for 3 days, cytarabine 100mg/m2/d for 5-7days) regimen
* ECOG (Eastern Cooperative Oncology Group) score: \<2
Exclusion Criteria
* Cardiac function level: 2 above
* Female in pregnancy or lactation
* With serious infection diseases or other diseases
18 Years
65 Years
ALL
No
Sponsors
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Changhai Hospital
OTHER
Responsible Party
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Xianmin Song
Associate Professor
Principal Investigators
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Xianmin Song, Doctor
Role: PRINCIPAL_INVESTIGATOR
Department of Hematology, Changhai Hospital
Locations
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Department of Hematology, Changhai Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Xianmin Song
Role: primary
Other Identifiers
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CHXY-AML01
Identifier Type: -
Identifier Source: org_study_id