Fludarabine and Cytarabine in Acute Myelogenous Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)
|ClinicalTrials.gov Identifier: NCT01019317|
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : December 3, 2013
Last Update Posted : March 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Leukemia AML MDS CML||Drug: Cytarabine Drug: Fludarabine||Phase 2|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||151 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome|
|Study Start Date :||November 2009|
|Actual Primary Completion Date :||September 2012|
|Actual Study Completion Date :||September 2012|
Experimental: Cytarabine + Fludarabine
Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
0.5 grams/m^2 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 Eastern Cooperative Oncology Group (ECOG) performance status (PS) > 3).
15 mg/m^2 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).
- Participants With a Complete Response [ Time Frame: Minimally 6 weeks (Cycle 1) up to 1 year (7 cycles) ]Complete Response (CR) was defined as: Neutrophil count ≥ 1.0 ×109/L, Platelet count ≥ 100 ×109/L, Bone marrow aspirate ≤5% blasts and No extramedullary leukemia. Response evaluation following Induction Therapy (Cycle 1) and every 2-3 cycles during Consolidation Therapy (Cycles 2 - 7) where Cycle is 4-6 weeks.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019317
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Study Chair:||Elias Jabbour, MD||UT MD Anderson Cancer Center|