Sodium Stibogluconate in the MDS/AML With One of the 65 Defined p53 Mutations
NCT04906031 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5
Last updated 2021-06-09
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 65 p53 mutations that were experimentally confirmed to be pharmacologically restored with tumor-suppressive function by antimonials.
Conditions
- Myelodysplastic Syndromes
- Acute Myeloid Leukemia
- Myeloid Malignancy
- Temperature-Sensitive p53 Mutation
- Sodium Stibogluconate
- P53 Mutation
Interventions
- DRUG
-
Sodium stibogluconate
Sodium stibogluconate 900 mg/m2/day will be given on d1-5 and d15-19. 28 days per cycle.
Sponsors & Collaborators
-
Ruijin Hospital
collaborator OTHER -
First Affiliated Hospital of Jinan University
lead OTHER
Principal Investigators
-
Min Lu, PHD · Ruijin Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-06-01
- Primary Completion
- 2023-02-01
- Completion
- 2024-02-01
Countries
- China
Study Locations
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