Clofarabine and Cytarabine in Treating Patients With Acute Myeloid Leukemia With Minimal Residual Disease
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|ClinicalTrials.gov Identifier: NCT00863434|
Recruitment Status : Terminated
First Posted : March 18, 2009
Results First Posted : May 15, 2017
Last Update Posted : May 15, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Trial of Clofarabine and Cytarabine to Treat Minimal Residual Disease (MRD) in Acute Myeloid Leukemia|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||February 2011|
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.
- 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 ]
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): 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|