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Effect of valproate sodiun in treatment of AML NON M3

Evaluation of response to addition of sodium valproate to cytarabine chemotherapy regimen in elderly patients with non-M3 AML

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240709062371N1
Enrollment
20
Registered
2024-10-05
Start date
2023-03-21
Completion date
Unknown
Last updated
2025-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia non m3. Acute myeloblastic leukemia

Interventions

Intervention 1: Intervention group: the group that receives sodium valproate 200 mg three times a day from day 1 to day 28 of treatment plus cytarabine regimen 20 mg/m2 twice a day from day 1 to day 1

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: age more than 60 year with AML NON M3 normal liver function test normal ECG

Exclusion criteria

Exclusion criteria: sever liver disease and abnormal liver function test history depression and suiside history allergy to valproat sodium history use of anticonvulsion drugs

Design outcomes

Primary

MeasureTime frame
Response to cytarabine and sodium valproate regimen treatment after three treatment cycles based on bone marrow sampling as complete response, partial response or non-response to treatment. Timepoint: Evaluation bone marrow blast befor start of treatment and after three cycles treatment. Method of measurement: evaluation Pathology and/or flow cytometry examination of bone marrow biopsy.

Secondary

MeasureTime frame
Evaluation platelet and befor and after any treatment cycle. Timepoint: At the beginning of the intervention and on day 10,17 and 24 during the intervention. Method of measurement: Complete blood count differential.;Sepsis. Timepoint: At the beginning of the intervention and on day 10,17 and 24 during the intervention. Method of measurement: Clinical examination and fever chart, in case of positive blood culture.;Evaluation neutrophils before and after any treatment cycle. Timepoint: At the beginning of the intervention and on day 10,17 and 24 during the intervention. Method of measurement: Complete blood count differential.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHossein asgharipour

Shahid Beheshti University of Medical Sciences

Hosseinasgharipour@gmail.com+98 21 2675 5989

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026