Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy

Study Overview
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Brief Summary
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Personalization of AML therapy, require a reliable mechanism for accurate characterization of patient specific leukemia phenotype and genotype. Patient's specific leukemic phenotype or in practical clinical term, patient's leukemia sensitivity to induction therapy, should best investigated in-vivo during induction. Elimination of circulating leukemic blasts from peripheral blood by day 5 was shown to discriminate between good responders with superior long term survival and poor responders with poor outcome. However, many AML patients have no circulating blasts at diagnosis and even in those who have, elimination rate of it from peripheral blood was never correlated with actual response in bone marrow. Currently, the only available source for patient's specific leukemia profile, is the bone marrow sample at diagnosis. Since leukemic blasts are heterogeneous and come from multiple different clones, on diagnosis marrow consist a spectrum of chemotherapy sensitive and resistance clones. Clones may vary by their molecular abnormalities and results from on diagnosis marrow may overlook minor resistant but existing clones. Long term prognosis is determined by those resistant clones and though our interests should be focused into the abnormalities of these clones. Residual blasts on day 5 marrow may better represent the profile of patient's leukemic resistant clones.

Official Title
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Rapid Profiling of Bone Marrow, at Presentation and After 5 Days of Induction Therapy, a Sensitive Method for Identifying Resistant AML Clones

Conditions
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AML

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of acute myeloid leukemia other than APL Age > 18 Patient's considered by their physician fit for intensive induction therapy Exclusion Criteria: Withdrawal of informed consent or inability to consent Previous allogeneic transplantation. One of the following lab values persistent from presentation to day 5: Serum creatinine > 2mg/dl, Direct bilirubin > 2mg/dl SGOT (AST) > x4 upper limit of normal Left ventricular ejection fraction < 40% as assessed 2-D echocardiogram Coagulation abnormalities (INR > 1.6, PTT > x1.5 normal range)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| AML induction<br>Adults AML patients who were referred for intensive induction therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete remission | Bone marrow blasts <5% upon recovery from induction therapy | 30-54 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | two years | 
| relapse rate |  | two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, Induction