Uproleselan with chemotherapy vs chemo alone in adults with R/R AML
Research type
Research Study
Full title
A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan Administered with Chemotherapy versus Chemotherapy Alone in Patients with Relapsed/Refractory Acute Myeloid Leukemia.
IRAS ID
280022
Contact name
Michael Dennis
Contact email
Sponsor organisation
GlycoMimetics, Inc.
Eudract number
2018-001076-38
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
In this Phase III randomized, double-blind, clinical trial, researchers want to find out if Uproleselan, in combination with standard chemotherapy, can improve the treatment of adult patients with acute myeloid leukemia (AML) that has either returned (relapsed), or not responded (refractory) to previous treatment.
AML progresses rapidly if untreated, and even with current treatment options, the morbidity and mortality of the overall population with AML remains high. The preferred treatment options for AML are chemotherapy and stem cell transplant, both of which can cause serious or life threatening side effects.
Uproleselan is an investigational (experimental) drug that is being developed by GlycoMimetics Incorporated. In this study, Uproleselan will be given as an infusion. The hypothesis is that uproleselan may make the chemotherapy medicines more effective in the treatment of AML.
In this study, patients may be eligible to receive up to four cycles of uproleselan or placebo with standard chemotherapy. The first cycle (induction) is mandatory for all patients. Patients may then receive up to an additional three cycles (consolidation), depending upon their health status and how they respond to the first cycle. For the main part of the study, patients may be in the induction phase for up to 62 days, depending on the status of their AML and the treatment course prescribed. All patients will complete an End of Treatment visit and after this they will enter the indefinite follow-up phase of the study, whereby survival information will be gathered.
The study plans to enrol up to 380 adult patients (18-75 years of age) who have relapsed or refractory AML. Participants will be from approximately 65 investigative sites in North America, Europe and Australia. In the U.K., sites will be specialist centres with staff members who have expert knowledge and experience in this specific disease area.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
20/SC/0224
Date of REC Opinion
8 Jul 2020
REC opinion
Further Information Favourable Opinion