The first planned interim analysis of the phase 2/3 MIRACLE trial showed that adding liposomal annamycin to high-dose cytarabine (HiDAC) produced higher remission rates than HiDAC alone in patients with relapsed or refractory acute myeloid leukemia (AML).
After one treatment cycle, complete remission rates were 43% with the 190 mg/m² annamycin dose and 36% with the 230 mg/m² dose, compared with 12% for HiDAC alone. Composite complete remission rates were 50% and 57% in the annamycin groups, versus 29% in the control group.
Although the results were not statistically significant, an independent data monitoring committee recommended continuing the trial because of the strong trend favoring annamycin.
The study has enrolled 67 of the planned 90 patients in Part A. Researchers will continue evaluating both doses before selecting one for the larger Part B trial, which is expected to enroll about 222 additional patients.