Study to Assess Length of Remission With Intensive Chemotherapy in Rapidly Responding AML Patients.

Study Overview
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Brief Summary
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We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).

Detailed Description
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Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.

Official Title
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Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Procedure: Prescribing conventional chemotherapy while with holding allo-SCT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AML diagnosis, treated with 3+7 Induction chemotherapy Intermediate/standard risk AML Exclusion Criteria: Diagnosed of APL high risk molecular/cytogenetic score

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 61 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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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: One arm open study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: No allogeneic SCT<br>For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan | Procedure: Prescribing conventional chemotherapy while with holding allo-SCT<br>* Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT<br>* Other names: No Allogeneic for rapid responders;|
| Active Comparator: Standard post induction therapy<br>For slow responding AML patients, post induction therapy will be provided according to treating physician discretion | Procedure: Prescribing conventional chemotherapy while with holding allo-SCT<br>* Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT<br>* Other names: No Allogeneic for rapid responders;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival |  | Two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survivial |  | two years |