Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease
RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving clofarabine together with cytarabine may kill more cancer cells.
PURPOSE: This pilot phase II trial is studying how well giving clofarabine together with cytarabine works in treating patients with acute myeloid leukemia with minimal residual disease
|Adult Acute Myeloid Leukemia in Remission Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Recurrent Adult Acute Myeloid Leukemia||Drug: clofarabine Drug: cytarabine Biological: filgrastim||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase II Trial of Clofarabine and Cytarabine to Treat Minimal Residual Disease (MRD) in Acute Myeloid Leukemia|
- Minimal Residual Disease as Assessed by Bone Marrow Flow Cytometry [ Time Frame: Post-treatment ]Percent of white blood cells that are blasts in the bone marrow post-treatment.
- Disease-free Survival [ Time Frame: Every 3 months for 2 years, and then annually for 3 years ]
- Overall Survival [ Time Frame: Every 3 months for 2 years, and then annually for 3 years ]
|Study Start Date:||February 2009|
|Primary Completion Date:||February 2011 (Final data collection date for primary outcome measure)|
Experimental: Treatment (colony stimulating factor and chemotherapy)
Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
Other Names:Drug: cytarabine
Other Names:Biological: filgrastim
I. To test the ability of clofarabine + ara-C (cytarabine) to eliminate minimal residual (MRD) in acute myeloid leukemia (AML) patients whose bone marrows exhibit complete remission by morphology.
I. To determine the duration of complete remission after this treatment to minimize MRD.
Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily (QD) on days 1-5 and clofarabine intravenously (IV) over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 3 months for 2 years, and then annually for 3 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863434
|United States, Washington|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Pamela Becker||Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium|