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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01666 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
I. To determine the duration of complete remission after this treatment to minimize MRD.
OUTLINE:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (colony stimulating factor and chemotherapy) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clofarabine | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Minimal Residual Disease as Assessed by Bone Marrow Flow Cytometry | Percent of white blood cells that are blasts in the bone marrow post-treatment. | Post-treatment |
| Disease-free Survival | Every 3 months for 2 years, and then annually for 3 years | |
| Overall Survival | Every 3 months for 2 years, and then annually for 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pamela Becker | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| cytarabine | Drug | Given IV |
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| filgrastim | Biological | Given SC |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Minimal Residual Disease (blast %) as Assessed by Bone Marrow Flow Cytometry | Percent of white blood cells that are blasts (by flow cytometry). | Median | Full Range | percent of white blood cells |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Minimal Residual Disease as Assessed by Bone Marrow Flow Cytometry | Percent of white blood cells that are blasts in the bone marrow post-treatment. | Posted | Median | Full Range | percent of white blood cells | Post-treatment |
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| Primary | Disease-free Survival | Posted | Median | Full Range | months | Every 3 months for 2 years, and then annually for 3 years |
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| Primary | Overall Survival | Posted | Median | Full Range | months | Every 3 months for 2 years, and then annually for 3 years |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. clofarabine: Given IV cytarabine: Given IV filgrastim: Given SC | 0 | 2 | 2 | 2 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Exacerbation of depression | Psychiatric disorders | Systematic Assessment |
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| Left shoulder pain | General disorders | Systematic Assessment |
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| Macular Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pamela Becker, MD, PhD | University of Washington | 206-288-7273 | pbecker@uw.edu |
| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| D000077866 | Clofarabine |
| D003561 | Cytarabine |
| D000069585 | Filgrastim |
| D016179 | Granulocyte Colony-Stimulating Factor |
| ID | Term |
|---|---|
| D000227 | Adenine Nucleotides |
| D011685 | Purine Nucleotides |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D009711 | Nucleotides |
| D012265 | Ribonucleotides |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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