Evaluation of the effect of arsenic trioxide adding to standard regimen 7-3 in acute myeloid leukemia patients: a Randomized single blind clinical trial
Evaluation of effect and superiority of Arsenic plus standard chemotherapy versus standard chemotherapy alone in induction of complete remission in acute myeloid leukemia (exept m3).
Design
Two arm parallel group consist of control and intervention group to evaluate superiority of Arsenic. sample size are 112 patients that randomized by person who not involved in treatment process. Superiority.
Settings and conduct
Single blind randomized trial for evaluation of effect of adding arsenic to standard chemotherapy in acute myeloid leukemia patients. A third person at an external site randomized patients between two group ( A and B) to receive standard chemotherapy (A) and standard chemotherapy plus arsenic trioxide (B) . this study were done in academic state in one of the Tehran university of medical science hospital.
Participants/Inclusion and exclusion criteria
Newly Diagnosed primary non M3 AML, Age 15-59 years old
Intervention groups
control group receive Standard chemotherapy regimen consist of 7 days infusion cytarabine 100 mg /m2 + danourubicine 60 mg /m2 or for 3 days. intervention group receive Standard chemotherapy regimen as above + arsenic trioxide 0.15 m/kgfor 21 days.
Main outcome variables
Complete Remission (CR): Hematologic complete remission is defined as meeting all of the following response criteria for at least four weeks. < 5% blasts in the bone marrow; No blasts with Auer rods
Normal maturation of all cellular components in the bone marrow
No extramedullary disease (e.g., CNS, soft tissue disease)
Neutrophils ≥ 1,000/µL
Platelets ≥ 100,000/µL
Transfusion independent
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20140818018842N16
Registration date:2019-12-22, 1398/10/01
Registration timing:retrospective
Last update:2019-12-22, 1398/10/01
Update count:0
Registration date
2019-12-22, 1398/10/01
Registrant information
Name
Leyla Sharifi Aliabadi
Name of organization / entity
Research Institute for Hematology, Oncology and Stem Cell Transplantation,Tehran University of Medic
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3691
Email address
ctu@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-22, 1396/10/01
Expected recruitment end date
2019-12-22, 1398/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effect of arsenic trioxide adding to standard regimen 7-3 in acute myeloid leukemia patients: a Randomized single blind clinical trial
Public title
Effect of arsenic trioxide in induction of complete remission of acute myeloid leukemia(non m3)
Purpose
Treatment
Inclusion/Exclusion 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 < 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
Age
From 15 years old to 69 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into 2 study groups by balanced block randomization. The list of randomized patients is made by a person not involved in the study and then the participants are randomly assigned into treatment groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The computer gives each patient a code number. And the code numbers are then allocated to the treatment groups control(standard chemotherapy receiver) and intervention group(arsenic plus standard chemotherapy receiver). In this study, neither the participants nor the researchers know which participants belong to the placebo group, nor the intervention group. Only at the end of the study, the results are reported by a person not involved in the study
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University Medical Sciences
Street address
Ethics Committee of Tehran University of Medical Sciences, Keshavarz Boulevard, Tehran town.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-10-26, 1396/08/04
Ethics committee reference number
Ir.tums.medicine.rec.1396.4484
Health conditions studied
1
Description of health condition studied
Acute myeloid leukemia ( non m3)
ICD-10 code
C92.0
ICD-10 code description
Acute myeloblastic leukemia
Primary outcomes
1
Description
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 outcomes
1
Description
overall survival
Timepoint
3 years after treatment completion
Method of measurement
follow up
2
Description
Disease free survival
Timepoint
3 years after treatment completion (1 - 2 months interval)
Method of measurement
follow up
3
Description
Arsenic Safty
Timepoint
within first 28 days
Method of measurement
Patient monitoring and Electrocardiography monitoring and laboratory tests
Intervention groups
1
Description
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) plus arsenic at 0.15 mg/kg for 21 days.
Category
Treatment - Drugs
2
Description
control group: received standard chemotherapy regimen consist of 7 days cytarabin at 100mg/m2 and 3 days daunorubicin at 60 mg/m2.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hematology, Oncology and stem cell transplantation rsearch center
Full name of responsible person
Mohammad Vaezi
Street address
Kargar shomali Ave., Shariati hospital
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Email
ctu@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hematology, Oncology & Stem Cell Transplantation Research Center, Tehran University of Medical Sci.
Full name of responsible person
Asadollah Musavi
Street address
Shariati Hospital, Kargar Shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Email
ctu@tums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hematology, Oncology & Stem Cell Transplantation Research Center, Tehran University of Medical Sci.
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Reza Manouchehri Ardekani
Position
Flowship of Hematology and Oncology
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shariati Hospital, Kaargar shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
Email
manouchehrireza9@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Mohammad Vaezi
Position
Assistant Professor hematology and oncology
Latest degree
Subspecialist
Other areas of specialty/work
Hematology and medical oncology
Street address
Shariati Hospital, Kaargar Shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
Email
ctu@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hematology- Oncology and Stem Cell Transplantation Research Center, Tehran University of Medical Sci
Full name of responsible person
Leyla Sharifi Aliabadi
Position
BSN
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shariati Hospital, Kargar Shomali Ave.
City
Tehran
Province
Tehran
Postal code
1411713131
Phone
+98 21 8490 2635
Fax
Email
l-sharifi@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD