Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control AML, MDS, or CML in myeloid blast crisis. The safety of this drug combination will also be studied.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome|
- Patients Response Rate [ Time Frame: Following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7). Cycle is 4-6 weeks. ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Experimental: Cytarabine + Fludarabine
Fludarabine 15 mg/m2 IV every 12 hours x 5 days; Cytarabine 0.5 grams/m2 IV over 2 hours every 12 hours x 5 days.
0.5 grams/m2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients > 65 years and 3 days in patients with PS > 3).
Other Names:Drug: Fludarabine
15 mg/m2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients > 65 years and 3 days in patients with PS > 3).
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|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Elias Jabbour, MD||UT MD Anderson Cancer Center|