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

NCT01576185 | Completed

• 4 other identifiers: AAML12B8NCI-2012-00724COG-AAML12B8CDR0000730390
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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.

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

Interventions

laboratory biomarker analysis OTHER

Correlative studies

Observational (xenograft models)

quizartinib DRUG

Via gavage

Also known as: AC220, class III receptor tyrosine kinase inhibitor AC220

Observational (xenograft models)

sorafenib tosylate DRUG

Via gavage

Also known as: BAY 43-9006, BAY 43-9006 Tosylate Salt, BAY 54-9085, Nexavar, SFN

Observational (xenograft models)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cryopreserved human AML samples FLT3-ITD samples with high allelic ratios

You may qualify if:

• Cryopreserved human AML samples
• FLT3-ITD samples with high allelic ratios

Sponsors & Collaborators

• Children's Oncology Group: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Children's Oncology Group

Monrovia, California, 91006-3776, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

tissue

MeSH Terms

Interventions

quizartinib; Sorafenib

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Sarah Tasian, MD

  Children's Oncology Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2012
• First Posted: April 12, 2012
• Study Start: May 1, 2012
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)