Status:
UNKNOWN
Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations
Lead Sponsor:
First Affiliated Hospital of Jinan University
Collaborating Sponsors:
Ruijin Hospital
Conditions:
Myelodysplastic Syndromes
Acute Myeloid Leukemia
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and effectiveness of Sodium Stibogluconate in the treatment of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML) with p53 mutation from a defined list. The list includes...
Detailed Description
p53 is inactivated by over hundreds of diverse mutations in cancer. The investigator purposefully selected the phenotype-reversible temperature-sensitive (TS) p53 mutations for pharmacological rescue,...
Eligibility Criteria
Inclusion
- Pathologically confirmed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
- Patients with one of the 65 antimonial-treatable p53 mutations with \> 5% VAF: Q136P, Y234H, V272M, F270V, P278A, R213L, Y126H, T253N, T253I, R158L, Q136E, P142F, A129D, L194R, R110P, V172G, C176F, I254N, K305R, E285D, T155P, H296D, E258G, G279V, T211A, R213P, C229Y, I232F, E294K, P152R, R196P, M160T, N131S, N131H, K139N, L330H, Y220N, E298Q, D148E, L264R, E224D, H168P, N263H, K320N, S227C, E286D, K292T, V203A, M237R, F212L, K132Q, Y236S, Y126S, Q136H, E221A, I232S, Y163H, P190T, C182Y, P142L, Y163S, V218E, I195S, V272A, and S106R.
- Life expectancy \>12 weeks.
- ECOG Performance status \< 3.
- Aged from 18 to 75.
- Active bone marrow hyperplasia indicated by morphology.
- Normal liver and renal function, bilirubin ≤35μmol/L, ASL/ALT lower than 2xULN, creatinine level ≤150μmol/L.
- Normal cardiac function.
- Lung function: dyspnea ≤ CTC AE grade 1 and SaO2≥ 92% in indoor air environment.
- Written Informed consent.
Exclusion
- Confirmed CNS involvement.
- Severe cardiac diseases including myocardial infarction or heart insufficiency.
- QT interval ≥450ms on ECG.
- With other visceral malignancy.
- Active tuberculosis or HIV(+).
- Patients with pregnancy or lactation.
- Allergic or significantly contraindicated to any drugs involved in intervention.
- Previous intolerance or allergy history to similar drugs.
- Participation at same time in another study in which investigational drugs are used.
- Any other conditions interfering the study.
- Abnormal liver function which does not meet the inclusion criteria.
- ECOG performance status ≥3, CCI \>1, ADL \<100.
- Aged \<18 years or \>75years
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04906031
Start Date
June 1 2020
End Date
February 1 2024
Last Update
June 9 2021
Active Locations (1)
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1
First Affiliated Hospital of Jinan University
Guangzhou, Guangdong, China, 510632