Leukemia Clinical Trial
Official title:
SCOR in Targeted Therapies for Infant Leukemias Project 2: Targeting Apoptosis in Leukemia in Infants
RATIONALE: Studying the effects of obatoclax mesylate in cell samples from patients with
cancer in the laboratory may help doctors learn more about the effects of obatoclax mesylate
on cancer cells. It may also help doctors identify biomarkers related to cancer.
PURPOSE: This research study is studying obatoclax mesylate in samples from young patients
with acute myeloid leukemia.
OBJECTIVES:
- 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.
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Observational Model: Case-Only, Time Perspective: Retrospective
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