Acute Myeloid Leukemia
Conditions
Brief summary
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
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.
Interventions
PROCEDUREPrescribing conventional chemotherapy while with holding allo-SCT
Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT
Sponsors
Rambam Health Care Campus
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
One arm open study
Eligibility
Sex/Gender
ALL
Age
18 Years to 61 Years
Healthy volunteers
No
Inclusion criteria
* AML diagnosis, * treated with 3+7 Induction chemotherapy * Intermediate/standard risk AML
Exclusion criteria
* Diagnosed of APL * high risk molecular/cytogenetic score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event free survival | Two years |
Secondary
| Measure | Time frame |
|---|---|
| Overall survivial | two years |
Contacts
Primary ContactYishai Ofran, MD
Outcome results
None listed