Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03616470|
Recruitment Status : Active, not recruiting
First Posted : August 6, 2018
Last Update Posted : April 6, 2022
|Condition or disease||Intervention/treatment||Phase|
|Acute Myeloid Leukemia||Drug: Uproleselan Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||388 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official 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|
|Actual Study Start Date :||October 15, 2018|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||December 2023|
Experimental: Uproleselan (GMI-1271)
Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
Placebo Comparator: Placebo (Saline, 0.9% Sodium Chloride)
Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)
Saline, 0.9% Sodium Chloride
- Overall survival [ Time Frame: 5 years ]Time from the date of randomization into the study to the date of death.
- Rate of severe oral mucositis [ Time Frame: up to 60 days ]Incidence of severe oral mucositis experienced in patients after treatment.
- Overall response rate [ Time Frame: Up to 60 days ]Proportion of subjects who achieve a complete remission [CR] or CR with partial recovery [CRh] of blood counts
- Event-free survival [ Time Frame: 2 years ]Time from date of randomization into the study to the date of treatment failure, relapse, or death from any cause; whichever occurs first.
- Duration of remission [ Time Frame: 2 years ]Time from date of first documented remission to date of relapse or death from any cause, whichever occurs first.
- Adverse events [ Time Frame: up to 5 months ]Frequency, severity, and relatedness of adverse events.
- Pharmacokinetic exposure (amount of uproleselan in the blood) [ Time Frame: up to 6 days ]The amount of uproleselan in the blood over time.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03616470
|Principal Investigator:||Daniel J DeAngelo, MD, PhD||Dana-Farber Cancer Institute|