US-based GlycoMimetics has revealed designs for its new Phase III clinical trial to analyse GMI-1271 in patients with relapsed/refractory acute myeloid leukemia (AML).
GMI-1271 will be analysed in combination with mitoxantrone, etoposide and Ara-C (MEC) or in combination with fludarabine, cytosine arabinoside and idarubicin (FAI).
The placebo-controlled trial expects to enrol 380 adult patients across the globe.
Scheduled to begin in the third quarter of this year, the trial complies with the guidance of the US Food and Drug Administration (FDA).
The trial’s primary objective is overall survival, while censoring for transplant in the primary efficacy analysis will not be required.
Its key secondary endpoints include incidence of severe mucositis and remission rate, which will be evaluated in a hierarchical manner for potential inclusion in the product labelling, if GMI-1271 is approved by the FDA.
GlycoMimetics CEO Rachel King said: “Reaching alignment with the FDA on overall survival as the primary endpoint for the trial, without statistical censoring for transplant, positions GMI-1271 well for a potential successful outcome.
“Getting more patients to transplant following treatment with GMI-1271 is one of our goals for this therapy.
“If we accomplish this, we hope GMI-1271 will contribute to prolonged overall survival for relapsed/refractory AML patients.”
GlycoMimetics intends to receive topline data from the Phase lll trial by the end of 2020.
GMI-1271 is developed to block E-selectin, an adhesion molecule on cells in the bone marrow, from binding with blood cancer cells as a targeted approach to disrupting the mechanisms of leukemic cell resistance within the bone marrow microenvironment.
The drug was previously examined in a Phase I/II clinical trial for the treatment of both newly diagnosed elderly and relapsed/refractory patients with AML.