A Phase 1 interventional study of All-trans retinoic acid and Arsenic Trioxide in Acute Myeloid Leukemia, sponsored by First Affiliated Hospital Xi'an Jiaotong University. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-28.
Sponsored by First Affiliated Hospital Xi'an Jiaotong University · Phase 1, Interventional, and Treatment
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.
Acute myeloid leukemia (AML) is a genetically heterogeneous disease with a highly variable prognosis and an overall high mortality rate. The 5-year overall survival of adult AML patients is less than 50%, and only 20% of elderly patients survive over 2 years. Acute promyelocytic leukemia (APL) accounts for 10% - 15% of acute myeloid leukemia. Arsenic and ATRA are very effective treatments for APL, a distinct AML subtype characterized by the expression of the PML/RARA fusion protein. PML/RARA expression disrupts PML NBs and blunts p53 signaling, which contributes to increased self-renewal of myeloid progenitors. The application of all-trans retinoic acid (ATRA) and arsenic modifies APL from highly fatal to highly curable. Both RA and arsenic induce degradation of PML/RARA through distinct pathways. Nucleophosmin-1(NPM1) is the most frequently mutated gene in acute myeloid leukemia (AML). According to El Hajj's research, RA or arsenic trioxide synergistically induces proteasomal degradation of mutant NPM1 in AML cell lines or primary samples, leading to differentiation and apoptosis. Combined ATRA/arsenic treatment significantly reduced bone marrow blasts in 3 AML patients and restored the subnuclear localization of both NPM1 and PML. Overall, there is no consensus yet as to whether the addition of ATRA/arsenic improves the outcome of patients with NPM1 mutant AML. However, it still needs clinical research to confirm. The investigators design a clinical trial to prove that arsenic plus ATRA is possibly improving the symptoms of AML patients, reduce early mortality, and extending overall survival time.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 30 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →First Affiliated Hospital Xi'an Jiaotong University is the lead sponsor of 306 studies on the registry; 86 are open to participants now.
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Exclusion Criteria:
ATRA 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.
Drug: All-trans retinoic acid · Drug: Arsenic Trioxide · Drug: Realgar-Indigo naturalis formula
All-trans retinoic acid (ATRA) 20mg 3 times a day for 8 weeks.
Also known as: ATRA
ATO 0.15mg/kg/d for 8 weeks (If the total daily amount is greater than 10mg, only 10mg/d can be given)
Also known as: ATO
60 mg/kg/d for 8 weeks
Also known as: RIF
Early death rate (ED)
Death reported within the first month of diagnosis
Time frame: 30 days
Overall survival (OS)
the time from enrolled to death from any cause
Time frame: From date of enrollment until the date of death from any cause, assessed up to 3 years
Hematologic complete remission (HCR)
Bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count \>1.0×10\^9 /L; platelet count \>100× 10\^9 /L.
Time frame: 30 days
Cumulative relapse rate
Time frame: From the date of enrollment to the date of relpase proved by bone marrow test, assessed up to 3 years
Plan to share: No
This study is status unknown, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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First Affiliated Hospital Xi'an Jiaotong University