Drug Biomarkers in Cell Samples From Patients With Acute Myeloid Leukemia

• Sponsor: Children's Oncology Group (Other)
• Overall Status: Completed
• CT.gov ID: NCT01150058
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 40
• Duration (Months): 24

Study Details

Study Description

Brief Summary

RATIONALE: Studying cell samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

PURPOSE: This research study is studying drug biomarkers in cell samples from patients with acute myeloid leukemia.

Condition or Disease	Intervention/Treatment	Phase
Leukemia	Genetic: western blotting; Other: flow cytometry; Other: laboratory biomarker analysis

Detailed Description

OBJECTIVES:

• To determine, in vitro, the cytotoxic activity of novel CD33-targeting immunoconjugate agents in cell samples from patients with acute myeloid leukemia (AML).

• To define the characteristics of AML cells responding to or resisting these agents.

OUTLINE: Cell samples are thawed and used for in vitro studies to determine the cytotoxic activity of novel CD33-targeting immunoconjugate agents, including gemtuzumab ozogamicin, for genotyping characterization by flow cytometry-based assays and/or western blot, and colony-forming cell assays.

Study Design

• Study Type: Observational
• Actual Enrollment: 40 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: Preclinical Evaluation of Novel CD33-Targeting Therapeutics for Treatment of Acute Myeloid Leukemia (AML)
• Study Start Date: Nov 1, 2010
• Actual Primary Completion Date: Nov 1, 2012
• Actual Study Completion Date: Nov 1, 2012

Outcome Measures

Primary Outcome Measures

1. Activity of novel CD33-targeting immunoconjugate agents []

2. Genotypic characteristics of acute myeloid leukemia cells []

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 30 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Diagnosis of acute myeloid leukemia

• Cryopreserved samples available

PATIENT CHARACTERISTICS:

• Not specified

PRIOR CONCURRENT THERAPY:

• Not specified

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Soheil Meshinchi, MD, Fred Hutchinson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Children's Oncology Group
• ClinicalTrials.gov Identifier: NCT01150058
• Other Study ID Numbers: AAML10B19; COG-AAML10B19; NCI-2011-02241; AAML10B19
• First Posted: Jun 24, 2010
• Last Update Posted: May 12, 2015
• Last Verified: May 1, 2015

• Keywords provided by Children's Oncology Group: adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with del(5q); adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22); childhood acute myeloid leukemia/other myeloid malignancies; adult acute myeloid leukemia
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of May 12, 2015