Acute myeloid leukemia. Acute myeloblastic leukemia
Conditions
Interventions
Intervention 1: Intervention group: sodium valproate drug with a dose of 200 mg three times a day from the first day to the 21st day of treatment to the 3+7 regimen (7 days of cytarabine with a dose o
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Recipient of 3+7 regimen diagnosed with AML non M3 People over 18 years old having normal liver function Normal baseline ECG
Exclusion criteria
Exclusion criteria: severe liver failure (liver enzymes more than three times the normal limit) History of allergy and sensitivity to sodium valproate History of taking other anticonvulsant drugs History of depression and suicide
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage and time to reach complete remission (CR). Timepoint: Daily CBC and bone marrow biopsy on day 14 to 21 of treatment cycle. Method of measurement: The presence of less than 5% blasts in the bone marrow sample in the bone marrow biopsy between days 14 and 21 and the absence of blasts in the peripheral blood along with the number of neutrophils more than 1500 per microliter and platelets more than 100,000 per microliter.;The rate of febrile neutropenia. Timepoint: Vital signs chart every 6 hours including body temperature and daily blood cell count test. Method of measurement: Measurement of body temperature by thermometer and daily evaluation of the absolute neutrophil count (ANC) in the laboratory. | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of sepsis. Timepoint: Evaluation in case of fever and other symptoms suggestive of sepsis. Method of measurement: Performing blood cultures and other cultures if necessary. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMojtaba Ghadiany
Shahid Beheshti University of Medical Sciences
Outcome results
None listed