Developing and Treating a Mouse Model of Acute Myeloid Leukemia Using Tissue Samples From Younger Patients With Acute Myeloid Leukemia

NCT ID: NCT01576185

Last Updated: 2016-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

quizartinib

Intervention Type DRUG

Via gavage

sorafenib tosylate

Intervention Type DRUG

Via gavage

Interventions

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laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

quizartinib

Via gavage

Intervention Type DRUG

sorafenib tosylate

Via gavage

Intervention Type DRUG

Other Intervention Names

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AC220 class III receptor tyrosine kinase inhibitor AC220 BAY 43-9006 BAY 43-9006 Tosylate Salt BAY 54-9085 Nexavar SFN

Eligibility Criteria

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Inclusion Criteria

* Cryopreserved human AML samples

* FLT3-ITD samples with high allelic ratios
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Children's Oncology Group

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sarah Tasian, MD

Role: PRINCIPAL_INVESTIGATOR

Children's Oncology Group

Locations

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Children's Oncology Group

Monrovia, California, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2012-00724

Identifier Type: REGISTRY

Identifier Source: secondary_id

COG-AAML12B8

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000730390

Identifier Type: OTHER

Identifier Source: secondary_id

AAML12B8

Identifier Type: -

Identifier Source: org_study_id

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