Treatment of Acute Myeloid Leukemia With Arsenic and All-trans Retinoid Acid
1 other identifier
interventional
30
1 country
1
Brief Summary
The clinical trial was designed to prove that Arsenic plus ATRA possibly had an effect on improving the symptoms, reducing the early mortality rate and prolonging the total survival time of patients with newly diagnosed or relapsed AML.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2019
Longer than P75 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 3, 2019
CompletedFirst Submitted
Initial submission to the registry
October 8, 2021
CompletedFirst Posted
Study publicly available on registry
March 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedMarch 28, 2022
August 1, 2021
4.8 years
October 8, 2021
March 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Early death rate (ED)
Death reported within the first month of diagnosis
30 days
Overall survival (OS)
the time from enrolled to death from any cause
From date of enrollment until the date of death from any cause, assessed up to 3 years
Secondary Outcomes (2)
Hematologic complete remission (HCR)
30 days
Cumulative relapse rate
From the date of enrollment to the date of relpase proved by bone marrow test, assessed up to 3 years
Study Arms (1)
ATRA/arsenic Group
EXPERIMENTALATRA 20mg 3 times a day for 8 weeks Arsenic can be given intravenously (ATO) or oral Realgar-Indigo naturalis formula(RIF) ATO 0.15mg/kg/d for 8 weeks (If the total daily amount is greater than 10mg, only 10mg/d can be given) RIF 60 mg/kg/d for 8 weeks The total dose can be appropriately adjusted according to the side-effects of the drug. 4 weeks for 1 course. If the patient has obvious side effects, the treatment should stop for 2 weeks. Each patient will be received at least two courses. Quality of life assessments are performed every 2 months. After the end of the course of treatment, the condition is mainly evaluated based on the platelet count and bone marrow smear. If the treatment is effective, the above regimen can be continued; if not, the study is withdrawn.
Interventions
All-trans retinoic acid (ATRA) 20mg 3 times a day for 8 weeks.
ATO 0.15mg/kg/d for 8 weeks (If the total daily amount is greater than 10mg, only 10mg/d can be given)
Eligibility Criteria
You may qualify if:
- Newly diagnosed or relapsed AML.Diagnosis based on Chinese guidelines for diagnosis and treatment of adult acute myeloid leukemia(not APL)(2018)
- Older than 18 years old
- Patients or their families signed written informed consent
You may not qualify if:
- Be allergic to the drug ingredient, the supplementary material or the allergic constitution person
- Cardiac insufficiency, renal insufficiency, significant arrhythmias, EKG abnormalities or other important organ dysfunction
- Combined with other malignant tumors
- Pregnant and lactating women
- Participants in other drug trials in the last 3 months
- Suffering from mental illness or other circumstances which unable to carry out the plan
- Other patients who were not suitable for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710016, China
Related Publications (5)
Bennett DA. How can I deal with missing data in my study? Aust N Z J Public Health. 2001 Oct;25(5):464-9.
PMID: 11688629BACKGROUNDDos Santos GA, Kats L, Pandolfi PP. Synergy against PML-RARa: targeting transcription, proteolysis, differentiation, and self-renewal in acute promyelocytic leukemia. J Exp Med. 2013 Dec 16;210(13):2793-802. doi: 10.1084/jem.20131121.
PMID: 24344243BACKGROUNDde The H, Chen Z. Acute promyelocytic leukaemia: novel insights into the mechanisms of cure. Nat Rev Cancer. 2010 Nov;10(11):775-83. doi: 10.1038/nrc2943. Epub 2010 Oct 22.
PMID: 20966922BACKGROUNDZhao Z, Zuber J, Diaz-Flores E, Lintault L, Kogan SC, Shannon K, Lowe SW. p53 loss promotes acute myeloid leukemia by enabling aberrant self-renewal. Genes Dev. 2010 Jul 1;24(13):1389-402. doi: 10.1101/gad.1940710.
PMID: 20595231BACKGROUNDEl Hajj H, Dassouki Z, Berthier C, Raffoux E, Ades L, Legrand O, Hleihel R, Sahin U, Tawil N, Salameh A, Zibara K, Darwiche N, Mohty M, Dombret H, Fenaux P, de The H, Bazarbachi A. Retinoic acid and arsenic trioxide trigger degradation of mutated NPM1, resulting in apoptosis of AML cells. Blood. 2015 May 28;125(22):3447-54. doi: 10.1182/blood-2014-11-612416. Epub 2015 Mar 23.
PMID: 25800051BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Huaiyu Wang, Dr.
First Affiliated Hospital Xi'an Jiaotong University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 8, 2021
First Posted
March 28, 2022
Study Start
February 3, 2019
Primary Completion
December 3, 2023
Study Completion
December 31, 2023
Last Updated
March 28, 2022
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share