Clinical trial · Interventional
Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations
Sodium Stibogluconate in the Myelodysplastic Syndromes/Acute Myeloid Leukemia With One of the 65 Defined p53 Mutations That Can be Functionally Rescued by Sodium Stibogluconate
NCT04906031CI-TRIAL-00052186unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 65 p53 mutations that were experimentally confirmed to be pharmacologically restored with tumor-suppressive function by antimonials.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
| Myeloid Malignancy | — | UNRESOLVED | — |
| P53 Mutation | — | UNRESOLVED | — |
| Sodium Stibogluconate | — | UNRESOLVED | — |
| Temperature-Sensitive p53 Mutation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sodium stibogluconate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sodium stibogluconate
- description
- Sodium stibogluconate 900 mg/m2/day will be given on d1-5 and d15-19. 28 days per cycle.
- interventionNames
- Drug: Sodium stibogluconate
Primary outcomes (1)
- measure
- Overall response rate
- timeFrame
- At the end of Cycle 4 (each cycle is 28 days)
- description
- Partial response (PR) + complete response (CR) rate
Secondary outcomes (1)
- measure
- Adverse Event (AE)
- timeFrame
- At the end of Cycle 4 (each cycle is 28 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Pathologically confirmed myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML). 2. 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. 3. Life expectancy \>12 weeks. 4. ECOG Performance status \< 3. 5. Aged from 18 to 75. 6. Active bone marrow hyperplasia indicated by morphology. 7. Normal liver and renal function, bilirubin ≤35μmol/L, ASL/ALT lower than 2xULN, creatinine level ≤150μmol/L. 8. Normal cardiac function. 9. Lung function: dyspnea ≤ CTC AE grade 1 and SaO2≥ 92% in indoor air environment. 10. Written Informed consent. Exclusion Criteria: 1. Confirmed CNS involvement. 2. Severe cardiac diseases including myocardial infarction or heart insufficiency. 3. QT interval ≥450ms on ECG. 4. With other visceral malignancy. 5. Active tuberculosis or HIV(+). 6. Patients with pregnancy or lactation. 7. Allergic or significantly contraindicated to any drugs involved in intervention. 8. Previous intolerance or allergy history to similar drugs. 9. Participation at same time in another study in which investigational drugs are used. 10. Any other conditions interfering the study. 11. Abnormal liver function which does not meet the inclusion criteria. 12. ECOG performance status ≥3, CCI \>1, ADL \<100. 13. Aged \<18 years or \>75years
References
Publications (1)
- DERIVEDTang Y, Song H, Wang Z, Xiao S, Xiang X, Zhan H, Wu L, Wu J, Xing Y, Tan Y, Liang Y, Yan N, Li Y, Li J, Wu J, Zheng D, Jia Y, Chen Z, Li Y, Zhang Q, Zhang J, Zeng H, Tao W, Liu F, Wu Y, Lu M. Repurposing antiparasitic antimonials to noncovalently rescue temperature-sensitive p53 mutations. Cell Rep. 2022 Apr 12;39(2):110622. doi: 10.1016/j.celrep.2022.110622. PMID 35417717