Aml Clinical Trial
— PANDA-T0Official title:
Combination of Decitabine and ATO to Treat AML/MDS Expressing a Classified Type of Mutant p53
TP53 mutation is commonly associated with poor cancer patient prognosis yet no mutant p53 (mp53)-targeting regimen was clinically established. Here the investigators try to evaluate the side effect and treatment potential of DAC+ATO in p53 mutated high-risk AML/MDS patients. About 200 AML/MDS patients will be sequenced for TP53 sequence before recruitment. The investigators estimated about 5 patients, based on the reported p53 mutation frequency in AML/MDS, will be p53-mutated. In the trial, the investigators will selectively recruit the mp53 AML/MDS patients that are predicted to respond to DAC+ATO regimen with highest chance (based on the relevant basic studies). The investigators designate mutant p53-based clinical trials as 'PANDA (P53 AND Arsenic)-Trials'.
Status | Recruiting |
Enrollment | 5 |
Est. completion date | July 2024 |
Est. primary completion date | July 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | Inclusion Criteria: - Occurrence of p53 mutants that are predicted to respond to ATO+DAC with highest chance - Patients newly diagnosed with myelodysplastic syndromes. - 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 - Written Informed consent. Exclusion Criteria: - Patients previously treated. - Confirmed CNS involvement. - Abnormal liver function which does not meet the inclusion criteria. - 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. - Significantly contraindicated to HMA chemotherapy. - ECOG performance status =3, CCI >1, ADL <100. - Unable to understand or follow the study protocol. - Previous intolerance or allergy history to similar drugs. - Aged <18 yrs or >75yrs - MDS patients previously treated with decitabine. - Participation at same time in another study in which investigational drugs are used. - Any other conditions interfering the study. |
Country | Name | City | State |
---|---|---|---|
China | Hematological department, Shanghai Institute of Hematology, Ruijin Hospital | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Ruijin Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | side effect | evaluate the side effects of current regimen | during the whole treatment | |
Secondary | Overall response rate | Partial response (PR) + complete response (CR) rate | at the end of cycle 4 (each cycle is 28 days) |
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