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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00724 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| COG-AAML12B8 | Other Identifier | Children's Oncology Group | |
| CDR0000730390 | Other Identifier | Clinical Trials.gov |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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These laboratory trial studies the development and treatment of a mouse model for acute myeloid leukemia (AML) using samples from younger patients with AML. Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about cancer and how well patients will respond to treatment.
PRIMARY OBJECTIVES:
I. To determine the rate of engraftment of pediatric FMS-Like Tyrosine Kinase-3 (FLT3)-internal tandem duplication (ITD) acute myeloid leukemia (AML) samples in NOD scid gamma (NSG) mice.
II. To determine the efficacy of treatment of FLT3-ITD xenografts with tyrosine kinase inhibitors.
OUTLINE:
Human acute myeloid leukemia cells are injected into NSG mice. Mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. Peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human CD45+ and CD33+ cells by quantitative flow cytometry.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (xenograft models) | Human acute myeloid leukemia cells are injected into NSG mice. Mice are then treated with sorafenib or quizartinib via gavage once daily for 28 days. Peripheral blood and tissue samples are collected biweekly or weekly and analyzed for the presence of human CD45+ and CD33+ cells by quantitative flow cytometry. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Correlative studies |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Engraftment ratio of human AML cells to murine cells | We will measure total leukemic burden from harvested femurs, tibias, and spleen by quantitative flow cytometry, estimate engraftment, and describe 95% confidence intervals. The total AML cell count of the control and treatment cohorts will be compared using an analysis of variance (ANOVA) test. | Up to 9 months |
| Efficacy of sorafenib or quizartinib to inhibit AML proliferation in vivo | Up to 9 months |
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Inclusion Criteria:
Cryopreserved human AML samples
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Cryopreserved human AML samples FLT3-ITD samples with high allelic ratios
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| Name | Affiliation | Role |
|---|---|---|
| Sarah Tasian, MD | Children's Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Oncology Group | Monrovia | California | 91006-3776 | United States |
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tissue
| quizartinib |
| Drug |
Via gavage |
|
|
| sorafenib tosylate | Drug | Via gavage |
|
|
| ID | Term |
|---|---|
| C544967 | quizartinib |
| D000077157 | Sorafenib |
| ID | Term |
|---|---|
| D010671 | Phenylurea Compounds |
| D014508 | Urea |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009536 | Niacinamide |
| D009539 | Nicotinic Acids |
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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