Fludarabine, Cytarabine, Filgrastim and Idarubicin in Core Binding Factor (CBF) Leukemias
The goal of this clinical research study is to learn if idarubicin can be added to the combination of fludarabine, cytarabine, and Neupogen (Filgrastim) without increasing the risk of side effects. This study will also look at whether the addition of idarubicin will increase the long-term chances of patients remaining disease free.
Acute Myelogenous Leukemia
Drug: G-CSF (Filgrastim, Neupogen)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase 2 Study of Fludarabine, Cytarabine, Filgrastim and Idarubicin in Newly Diagnosed Core Binding Factor Associated Acute Myelogenous Leukemia|
- Complete Response (CR) Rate and Toxicity Rate [ Time Frame: Weekly blood tests, bone marrow aspirate Days 18-24 and at 4 + 7 months, blood tests every 2-3 months for 2 years ] [ Designated as safety issue: Yes ]
Response criteria recommended by the NCI and MDS International Working Group. Complete Response (CR): Peripheral blood counts, No circulating blasts, Neutrophil count ≥ 1.0 X 109/L, Platelet count ≥ 100 X 109/L, Bone marrow aspirate and biopsy, ≤5% blasts, No detectable auer rods, No extramedullary leukemia
CRp: Response as in CR but platelets <100 X 109/L
Partial response (PR): Peripheral blood counts, No circulating blasts, Neutrophil count ≥ 1.0 X 109/L, Platelet count ≥ 100 X 109/L, ≥ 50% reduction in bone marrow blasts over baseline
|Study Start Date:||April 2007|
|Estimated Study Completion Date:||April 2016|
|Estimated Primary Completion Date:||April 2016 (Final data collection date for primary outcome measure)|
Experimental: Fludarabine + Cytarabine + Idarubicin + G-CSF
G-CSF = Filgrastim or Neupogen
30 mg/m^2 intravenously days 1, 2, 3, 4, and 5 (infusion time approximately 30 minutes). Post-Remission Therapy will consist of 3 days rather than 5 days.
Other Name: Fludara®Drug: Cytarabine
2 g/m^2 intravenously over 4 hours daily days 1, 2, 3, 4, and 5; each infusion begins 3.5 hours after completion of that day's fludarabine infusion - Post-Remission Therapy will consist of 3 days rather than 5 days.
Other Names:Drug: G-CSF (Filgrastim, Neupogen)
5 mcg/kg body weight (rounded off to the nearest number) starting day-1 till recovery of absolute neutrophil count (ANC) to 1.0 x 109/L or above. (G-CSF will be started on day 2 for patients with presenting WBC count > 10 x 109/L. Post-Remission Therapy will consist of 4 days rather than 5 days.
Other Names:Drug: Idarubicin
6 mg/m2 by vein over 30 minutes to be given immediately after fludarabine administration on Days 3 and 4. Idarubicin will be administered as in induction cycle, in one post-remission cycle (from cycle 3-6). Idarubicin will be given immediately after fludarabine administration on Days 2 and 3.
Other Name: Idamycin
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00801489
|Contact: Gautam Borthakur, MD||713-563-1586|
|United States, Texas|
|The University of Texas M.D. Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Contact: Gautam Borthakur, MD 713-563-1586|
|Principal Investigator: Gautam Borthakur, MD|
|Principal Investigator:||Gautam Borthakur, MD||M.D. Anderson Cancer Center|