Effect of arsenic trioxide in induction of complete remission of acute myeloid leukemia(non m3)

Phase 3

Conditions: Acute myeloid leukemia ( non m3).
Acute myeloblastic leukemia
C92.0

Registration Number: IRCT20140818018842N16

Lead Sponsor: Hematology, Oncology & Stem Cell Transplantation Research Center, Tehran University of Medical Sci.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 112

Inclusion Criteria

Patients with a newly diagnosis of AML according to the criteria of the WHO 2016 revision
Age 15-59years
Diagnosis of primary AML other than acute promyeloctic leukemia (AML M3),
Adequate liver (serum bilirubin level < 2upper normal limit) and renal function test (serum creatinine <1.5upper normal limit or creatinine clearance >60)
Normal cardiac function
Females of childbearing age must have a negative serum pregnancy test
ECOG <=2
Signed consent

Exclusion Criteria

Newly diagnosed patients older than age 60.
CML in blastic crisis
Patients with cardiopathies including recurrent supraventricular arrhythmia and any type of sustained ventricular arrhythmia or conduction block (A-V block grade II or III)
Pregnant or breastfeeding women
History of preexisting neurological disorders ( seizure disorders)
Patients with active second malignancy, excluding adequately treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of effect of adding arsenic to standard chemotherapy on induction of complete remission of acute myeloid leukemia except m3. Timepoint: 14 and 28 days after start of chemotherapy we performed bone marrow examination to evaluate remission rate. Method of measurement: Bone marrow microscopic evaluation.

Secondary Outcome Measures

Name	Time	Method
Overall survival. Timepoint: 3 years after treatment completion. Method of measurement: follow up.;Disease free survival. Timepoint: 3 years after treatment completion (1 - 2 months interval). Method of measurement: follow up.;Arsenic Safty. Timepoint: within first 28 days. Method of measurement: Patient monitoring and Electrocardiography monitoring and laboratory tests.