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

Evaluation of the effect of arsenic trioxide adding to standard regimen 7-3 in acute myeloid leukemia patients: a Randomized single blind clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20140818018842N16

Enrollment

112

Registered

2019-12-22

Start date

2017-12-22

Completion date

Unknown

Last updated

2020-01-13

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: received Standard chemotherapy regimen consists of 3 days of an anthracycline e.g daunorubicin at 60 mg/m2 and 7 days of cytarabine (100 mg/m2 continuous infusion)

Eligibility

Sex/Gender

All

Age

15 Years to 69 Years

Inclusion criteria

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 60) Normal cardiac function Females of childbearing age must have a negative serum pregnancy test ECOG <=2 Signed consent

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactReza Manouchehri Ardekani

Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci

manouchehrireza9@gmail.com+98 21 8490 2635

Outcome results

None listed

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