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

C

Children's Oncology Group

Status

Completed

Conditions

Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Treatments

Other: laboratory biomarker analysis
Drug: sorafenib tosylate
Drug: quizartinib

Study type

Observational

Funder types

NETWORK
NIH

Identifiers

NCT01576185
AAML12B8
NCI-2012-00724 (Registry Identifier)
COG-AAML12B8 (Other Identifier)
CDR0000730390 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

  • Cryopreserved human AML samples

    • FLT3-ITD samples with high allelic ratios

Trial design

10 participants in 1 patient group

Observational (xenograft models)
Description:
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.
Treatment:
Drug: quizartinib
Drug: sorafenib tosylate
Other: laboratory biomarker analysis

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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