Daniel J. DeAngelo, MD, PhD, discusses the exploration of uproleselan plus chemotherapy in relapsed/refractory acute myeloid leukemia.
Daniel J. DeAngelo, MD, PhD, associate professor of Medicine, Harvard Medical School, physician, Adult Leukemia Program, Dana-Farber Cancer Institute, discusses the exploration of uproleselan (GMI-1271) plus chemotherapy in relapsed/refractory acute myeloid leukemia.
A phase 3 study (NCT03616470) is evaluating the efficacy and safety of uproleselan plus chemotherapy, vs placebo plus chemotherapy. The primary end point of the study is overall survival.
Eligible patients for this trial could be in first or second relapse after failing on an anthracycline regimen, DeAngelo says. Additionally, the study will utilize 2 different chemotherapy backbones of mitoxantrone, etoposide, and cytarabine (MEC), or fludarabine, cytarabine and idarubicin, DeAngelo explains. Notably, the MEC backbone was studied with uproleselan in a phase 1/2 trial (NCT02306291). Granulocyte colony stimulating factor (G-CSF) will not be used in the trial since safety concerns of G-CSF and E-selectin have not been thoroughly studied, DeAngelo notes.
Despite challenges of the COVID-19 pandemic, the phase 3 trial has met its accrual, DeAngelo continues. Investigators are waiting for the appropriate number of events before the study is unblinded, DeAngelo concludes.