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Association details:
| Biomarker: | TP53 mutation |
|---|---|
| Cancer: | Myelodysplastic Syndrome |
| Drug: | Inqovi (decitabine/cedazuridine) (DNMT inhibitor, Cytidine deaminase inhibitor) |
| Direction: | Resistant |
Evidence:
Source:
Title:
854 Prolonged Survival in Bi-Allelic TP53-Mutated (TP53mut) MDS Subjects Treated with Oral Decitabine/Cedazuridine in the Ascertain Trial (ASTX727-02)
Published date:
11/03/2022
Excerpt:
133 subjects with MDS/CMML were enrolled to ASCERTAIN and were randomly assigned either IV decitabine for cycle 1 and oral decitabine/cedazuridine for cycle 2 or the opposite treatment sequence....The median OS and LFS of the TP53mut population were 25.5 and 22.1 mo., respectively, compared to the TP53 WT group with mOS and LFS estimates 33.7 and 31.7 months, respectively...ASCERTAIN trial included 35% with TP53mut and this group had a worse survival than those with WT TP53...
DOI:
https://doi.org/10.1182/blood-2022-163841
Trial ID:
Source:
Title:
ASTX727 AND DONOR LYMPHOCYTE INFUSIONS AFTER ALLOGENEIC STEM CELL TRANSPLANTATION IN VERY HIGH RISK MDS OR AML PATIENTS Étude prospective de phase II évaluant l'ASTX727 et les injections des lymphocytes du donneur chez les patients atteints de syndrome myélodysplasique de très haut risque ou de leucémie aiguë myéloblastique
Excerpt:
...- Patients âgés de 18 à 70 ans - SMD ou LAM avec caryotype défavorable, défini par : -4 anomalies cytogénétiques ou plus, ou -3 anomalies cytogénétiques et mutation TP53 ou autre mutation défavorable (ASXL1, RUNX1), ou -3 anomalies cytogénétiques et caryotype monosomal, ou -Mutations impliquant le gène evi1 -Chimiothérapie préalable pour les patients atteints de LAM -Blastes médullaires < 20 % pour les SMD et < 10 % post chimiothérapie pour les LAM -Maladie non-proliférative -Donneur identifié (HLA compatible ou non-compatible) -Contraception adéquate chez les femmes de moins de 50 ans et chez les hommes. ...
Trial ID:
Source:
Title:
A Study of Oral Decitabine/Cedazuridine in Combination With Magrolimab in Participants With Intermediate- to Very High-Risk Myelodysplastic Syndromes (MDS)
Excerpt:
...Area Under the Plasma Concentration-Time Curve (AUC) of Oral Decitabine/Cedazuridine and Magrolimab`Overall Response Rate (ORR)`Rate of Hematologic Improvement (HI)`Duration of Progression Free Survival (PFS)`Leukemia-free Survival (LFS)`Percentage of Participants With Minimal Residual Disease (MRD)-Negative Status`Duration of Response (DOR)`Overall Survival (OS)`Number of Participants With International Prognostic Scoring System for Myelodysplastic Syndromes (IPSS-M) Score`Number of Participants With p53 Mutation...
