- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01576185
Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia
Development of Pediatric Acute Myeloid Leukemia Xenograft Models for the Testing of Targeted Therapeutic Agents
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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California
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Monrovia, California, United States, 91006-3776
- Children's Oncology Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
Cryopreserved human AML samples
- FLT3-ITD samples with high allelic ratios
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Correlative studies
Via gavage
Other Names:
Via gavage
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Engraftment ratio of human AML cells to murine cells
Time Frame: Up to 9 months
|
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.
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Up to 9 months
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Efficacy of sorafenib or quizartinib to inhibit AML proliferation in vivo
Time Frame: Up to 9 months
|
Up to 9 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Tasian, MD, Children's Oncology Group
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAML12B8
- 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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