Fludarabine and Cytarabine Versus High-dose Cytarabine for CBF-AML
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|ClinicalTrials.gov Identifier: NCT02926586|
Recruitment Status : Unknown
Verified April 2018 by Xianmin Song, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine.
Recruitment status was: Recruiting
First Posted : October 6, 2016
Last Update Posted : May 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia Core-Binding Factor||Drug: Fludarabine Drug: Cytarabine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fludarabine and Cytarabine Versus High-dose Cytarabine in Consolidation Treatment of Core-bing Factor Acute Myeloid Leukemia: A Prospective, Multicenter, Randomized Study|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2020|
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 1500mg/m2/d for 5 days intravenously.
Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4
Other Name: Fludara
Active Comparator: high-dose cytarabine
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.
2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
Other Name: Cytosar
- Percentage of participants with disease recurrence [ Time Frame: one year ]
- Percentage of Participants in survival [ Time Frame: one year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926586
|Contact: Xianmin Song, Doctorfirstname.lastname@example.org|
|Shanghai, Shanghai, China, 200080|
|Contact: Xianmin Song, Doctor 86-21-63240090-3932 email@example.com|
|Principal Investigator:||Xianmin Song, Doctor||Department of hematology, Shanghai General Hospital, No. 100 Haining Road, Shang|