Integrated Risk Stratification and Transplant Decision Making for Patients with Acute Myelogenous Leukemia

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Integrated Risk Stratification and Transplant Decision Making for Patients with Acute Myelogenous Leukemia

1.1 Primary Objective(s)

1. To determine the effect genomic mutations have on treatment recommendations and medical decision making with respect to allogeneic stem cell transplantation in CR1 in patients with intermediate risk AML.
2. To integrate novel mutation analysis, CD25 expression, minimal residual disease (MRD) analysis and clinical factors into an allogeneic transplantation medical-decision making model that refines risk assessment by using commercially available detailed genetic analysis.

1.2 Secondary Objective(s)

1. To determine the outcomes of these patients with intermediate risk disease and defining outcomes in these patients who do and do not undergo stem cell transplantation in CR1.

1.3 Additional Objective(s)

1. To obtain genomic data for data storage and future computational analysis and correlation with clinical data;
2. To perform a Health Economic Analysis of the impact of the genomic mutations on transplant decision making and estimates of patient outcomes;
3. To determine the relative sensitivity and cost of genomic mutations and standard FISH assays in detecting common AML-associated gene fusions.

Protocol Number: 021501
Phase: NA
Applicable Disease Sites: Leukemia, other
Drugs Involved:
Principal Investigator: Roger Strair
Research Nurse: Michelle Orlick
Scope: Local
Therapies Involved:
Participating Institutions: Rutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@cinj.rutgers.edu.

 

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