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An Observational Study to Determine How Integrated Risk Stratification Impacts Transplant Recommendations for Patients with Acute Myelogenous Leukemia And HighRisk Myelodysplastic Syndromes

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An Observational Study to Determine How Integrated Risk Stratification Impacts Transplant Recommendations for Patients with Acute Myelogenous Leukemia And HighRisk Myelodysplastic Syndromes

1.1 Primary Objective(s)

1. To determine the effect genomic mutations have on treatment recommendations and
whether a more expanded genomic panel changes medical decision-making in patients with AML.

1.2 Secondary Objective(s)

1. To determine the outcomes in regards to relapse free and overall survival of AML patients both for patients who do and do not undergo stem cell transplantation.
2. To evaluate the effect genomic mutations have on treatment recommendations and whether a more expanded genomic panel alters decisions for transplantation of patients with MDS defined as intermediate or high risk by IPSS-R.
3. To assess the cost-effectiveneness of utilizing a 6-gene vs 49-gene myeloid panel in
treatment decision-making.

1.3 Additional Objective(s)

1. To obtain both retrospective and prospective genomic and clinical data for refined
computational and correlative analyses, investigating the dynamics of leukemia clonal
architecture under therapy and determining the clinical value of mutated clones present in
samples collected during AML and MDS treatment (Dr. Khiabanian, Systems Biology)
2. To obtain data for subsequent long-term Health Economic Analysis of the impact of the
genomic mutations on transplant decision-making and estimates of patient outcomes.

Protocol Number: 021501
Phase: NA
Applicable Disease Sites: Leukemia, other
Drugs Involved:
Principal Investigator: Athena Kritharis
Scope: Local
Therapies Involved:
Participating Institutions: Rutgers Cancer Institute of New Jersey

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