placebo + cytarabine

The combination of placebo and cytarabine refers to the control treatment arm in the MIRACLE (Moleculin R/R AML AnnAraC Clinical Evaluation) trial, a Phase 2B/3 study sponsored by Moleculin Biotech. In this clinical context, patients with relapsed or refractory acute myeloid leukemia (AML) receive a placebo (0.9% Sodium Chloride Injection) for three consecutive days in combination with high-dose cytarabine (HiDAC, 2.0 g/m2/day) for five consecutive days. Cytarabine is a pyrimidine nucleoside analog that acts as an antimetabolite; it is converted intracellularly into cytarabine triphosphate, which competes with deoxycytidine triphosphate for incorporation into DNA. This process inhibits DNA polymerase and halts DNA synthesis, leading to cell death in rapidly dividing leukemic cells. This specific regimen serves as the standard-of-care comparator to evaluate the efficacy and safety of Annamycin, a next-generation anthracycline, when used in combination with cytarabine.

Other names

placebo + Ara-Cplacebo + HiDACplacebo + Cytosar-U