What type of study is this?

This is a Phase 2 study (also classified as: Human Clinical Trial).

August 22, 2025

Supplementary Figure S4 from A Phase 1b/2 Study of TP-0903 and Decitabine Targeting Mutant TP53 and/or Complex Karyotype in Patients with Untreated Acute Myeloid Leukemia ≥Age 60 Years

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Patients achieving complete remission showed significant changes in p-H2AX levels, indicating treatment effectiveness.
The assessment of p-H2AX was conducted using spectral flow cytometry on patients' blood collected at baseline and day 10.
Data on various response categories (CR, CRh, CRi) were analyzed to explore treatment outcomes with targeted therapy.
Findings may support the use of p-H2AX as a pharmacodynamic biomarker, warranting further studies in similar patient populations.

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Phase 1b/2 trial evaluates p-H2AX as a pharmacodynamic biomarker in patients with AML, suggesting TP-0903 may enhance treatment efficacy.

Eisenmann et al. (2025) studied this question.

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