Obatoclax Mesylate in Samples From Young Patients With Acute Myeloid Leukemia
NCT ID: NCT01150656
Last Updated: 2016-05-18
Study Results
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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COMPLETED
50 participants
OBSERVATIONAL
2010-06-30
Brief Summary
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PURPOSE: This research study is studying obatoclax mesylate in samples from young patients with acute myeloid leukemia.
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Detailed Description
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* Determine comprehensive gene and protein expression profiles of in vitro sensitivity and resistance to obatoclax mesylate in multiple-lineage leukemia (MLL)-rearranged cell lines and primary infant acute myeloid leukemia (AML) samples.
* Define optimum in vitro combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs in MLL-rearranged leukemia cell lines and primary infant AML samples.
* Identify synergistic combinations based on a pharmacodynamic modeling and simulation construct.
* Determine whether combinations of obatoclax mesylate targeting pro-survival BCL-2 family proteins with cytotoxic drugs improves survival in a xenograft model of MLL-rearranged infant AML.
OUTLINE: This is a multicenter study.
Obatoclax mesylate activity is assessed via the MTT assay. A priori features of acute myeloid leukemia (AML) blasts relating to the apoptosis and ATG cell death pathways and their execution are characterized using microarray analysis and quantitative real-time (Q-RT) PCR. Gene and protein expression is described and quantified using Q-RT PCR and western blot analysis at specific time points after obatoclax mesylate exposure to identify pharmacodynamic biomarkers of activity and characterize the cell death mechanism in multiple-lineage leukemia (MLL)+ AML. The MTT assay is performed using obatoclax mesylate-cytotoxic chemotherapy combinations to determine synergy focusing on common cytotoxic drugs employed in AML treatment regimens.
Obatoclax mesylate efficacy is tested in a therapeutic NOG xenograft model of primary MLL+ infant AML.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Interventions
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gene expression analysis
microarray analysis
protein expression analysis
reverse transcriptase-polymerase chain reaction
western blotting
laboratory biomarker analysis
pharmacological study
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute myeloid leukemia (AML)
* Cryopreserved samples from infants with AML available
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* Not specified
2 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Children's Oncology Group
NETWORK
Responsible Party
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Principal Investigators
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Carolyn A. Felix, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia
Other Identifiers
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COG-AAML10B17
Identifier Type: OTHER
Identifier Source: secondary_id
NCI-2011-02239
Identifier Type: REGISTRY
Identifier Source: secondary_id
AAML10B17
Identifier Type: OTHER
Identifier Source: secondary_id
AAML10B17
Identifier Type: -
Identifier Source: org_study_id
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