Phase 1 Study of Actinomycin D Combined with Venetoclax in Relapsed/Refractory Acute Myeloid Leukemia

The trial enrolled patients diagnosed with Relapsed/Refractory Acute Myeloid Leukemia (AML). Both male and female subjects were eligible, and the age distribution covered the categories indicated by codes 3 and 4, reflecting inclusion of adult and older adult participants. The sponsor did not provide the total number of participants. Selection required a confirmed diagnosis of the disease; no additional lifestyle or health status criteria were specified in the available data.

The ACTIVATE Phase 1 study evaluates the combination of Actinomycin D and venetoclax in adults with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML). The trial employs a randomized, double‑blind, controlled design to compare the investigational regimen with standard therapy. Recruitment is planned to begin in June 2026 and conclude in June 2029, defining the overall study timeline. Participants undergo an initial screening visit to confirm eligibility, followed by baseline assessments and randomization. Subsequent visits occur at defined intervals for drug administration, safety monitoring, pharmacokinetic sampling, and efficacy evaluation. The schedule culminates in an end‑of‑study visit that includes final assessments and data collection. Each subject remains in the study from screening through the end‑of‑study visit, encompassing the treatment period and scheduled follow‑up. Early termination may be implemented if predefined safety or efficacy criteria are met or if the participant withdraws consent.

Efficacy will be evaluated using predefined clinical endpoints appropriate for Relapsed/Refractory Acute Myeloid Leukemia. Assessments will be conducted according to the trial schedule, employing validated measurement tools and statistical analysis as specified in the protocol.