Phase I Epigenetic Priming Using Decitabine With Induction Chemotherapy in AML
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|ClinicalTrials.gov Identifier: NCT00538876|
Recruitment Status : Completed
First Posted : October 3, 2007
Last Update Posted : June 30, 2011
This is an open label phase I study designed to explore the feasibility, safety and biologic activity of epigenetic priming with decitabine prior to standard cytarabine, daunorubicin induction chemotherapy in younger patients with less-than-favorable risk AML.
Primary Objective: To find an appropriate dose level for decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML.
- To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML.
- To establish the optimal dose schedule of decitabine required to broadly demethylate cytosine residues in genomic regulatory regions.
- To investigate, in selected cases, the molecular and cellular consequences of decitabine-induced hypomethylation by a) establishing the extent and degree of hypomethylation at specific genomic loci required to reactivate the expression of repressed genes and by b) determining the effect of hypomethylation on the differentiation and/or apoptosis of leukemic blasts.
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: decitabine||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I Study of Epigenetic Priming Using Decitabine With Induction Chemotherapy in Patients With Acute Myelogenous Leukemia (AML)|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||December 2009|
|Actual Study Completion Date :||December 2009|
- To establish the safety and expected toxicities of decitabine when used as priming for cytarabine and daunorubicin "7+3" induction chemotherapy in AML [ Time Frame: duration of study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538876
|United States, New York|
|Weill Medical College of Cornell University|
|New York, New York, United States, 10021|
|Principal Investigator:||Joseph Scandura, MD||Weill Medical College of Cornell University|