Clincosm LogoSign in Get a demo

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

Sponsor
Children's Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT01576185
Collaborator
National Cancer Institute (NCI) (NIH)
10
Enrollment
1
Location
48
Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Detailed Description

PRIMARY OBJECTIVES:

  1. 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.

  2. 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 Design

Study Type:
Observational
Actual Enrollment :
10 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Development of Pediatric Acute Myeloid Leukemia Xenograft Models for the Testing of Targeted Therapeutic Agents
Study Start Date :
May 1, 2012
Actual Primary Completion Date :
May 1, 2016
Actual Study Completion Date :
May 1, 2016

Arms and Interventions

Arm 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.

Other: laboratory biomarker analysis
Correlative studies

Drug: quizartinib
Via gavage
Other Names:
  • AC220
  • class III receptor tyrosine kinase inhibitor AC220

    • Drug: sorafenib tosylate
    Via gavage
    Other Names:
  • BAY 43-9006
  • BAY 43-9006 Tosylate Salt
  • BAY 54-9085
  • Nexavar
  • SFN

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Engraftment ratio of human AML cells to murine cells [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.

    2. Efficacy of sorafenib or quizartinib to inhibit AML proliferation in vivo [Up to 9 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Cryopreserved human AML samples

    • FLT3-ITD samples with high allelic ratios

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Oncology Group Monrovia California United States 91006-3776

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Sarah Tasian, MD, Children's Oncology Group

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Children's Oncology Group
    ClinicalTrials.gov Identifier:
    NCT01576185
    Other Study ID Numbers:
    • AAML12B8
    • NCI-2012-00724
    • COG-AAML12B8
    • CDR0000730390
    First Posted:
    Apr 12, 2012
    Last Update Posted:
    May 17, 2016
    Last Verified:
    May 1, 2016
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Myeloid
    Leukemia, Myeloid, Acute
    Sorafenib

    Study Results

    No Results Posted as of May 17, 2016