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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No allogeneic SCT | Experimental | For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan |
|
| Standard post induction therapy | Active Comparator | For slow responding AML patients, post induction therapy will be provided according to treating physician discretion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prescribing conventional chemotherapy while with holding allo-SCT | Procedure | Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT |
| Measure | Description | Time Frame |
|---|---|---|
| Event free survival | Two years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survivial | two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yishai Ofran, MD | Contact | +972-4-7778026 | y_ofran@rambam.health.gov.il |
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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One arm open study
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|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |