Trial Profile
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
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 12 Sep 2023
Price :
$35
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At a glance
- Drugs Uproleselan (Primary) ; Cytarabine; Etoposide; Fludarabine; Idarubicin; Mitoxantrone
- Indications Acute myeloid leukaemia
- Focus Registrational; Therapeutic Use
- Sponsors GlycoMimetics
- 21 Jul 2023 Planned End Date changed from 1 Dec 2023 to 1 Dec 2024.
- 21 Jul 2023 Planned primary completion date changed from 1 Apr 2022 to 1 Jun 2024.
- 15 Jun 2023 According to a GlycoMimetics media release, the U.S. Food and Drug Administration (FDA) cleared the addition of a protocol amendment that will allow a time-based analysis of the primary endpoint of overall survival to be conducted following a defined cutoff date if the 295 survival events originally planned for an event driven analysis have not been observed.