Uproleselan + Chemotherapy for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

+70 other locations

Overseen byDaniel J DeAngelo, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlycoMimetics Incorporated

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing whether a drug called uproleselan can make chemotherapy more effective for patients with a type of blood cancer that has come back or not responded to treatment. Uproleselan works by blocking a protein that helps cancer cells hide in the bone marrow.

Research Team

Daniel J DeAngelo, MD, PhD

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

Adults aged 18-75 with relapsed or refractory Acute Myeloid Leukemia (AML) who haven't had more than one stem cell transplant and are medically eligible for chemotherapy. Excluded are those with recent use of certain growth factors, immunotherapy, radiotherapy, or chemotherapy; inadequate organ function; active hepatitis or HIV; moderate kidney dysfunction; uncontrolled infections; major surgery within the last month; specific types of leukemia other than AML.

Inclusion Criteria

I am between 18 and 75 years old.

I have had only one stem cell transplant.

My AML cancer has returned or is not responding to treatment.

See 2 more

Exclusion Criteria

I haven't used G-CSF, GM-CSF, or plerixafor in the last 7 days.

My leukemia is one of the specific types not eligible for this trial.

My cancer is affecting my brain or spinal cord.

See 9 more

Treatment Details

Interventions

Uproleselan (E-selectin Antagonist)

Trial OverviewThe trial is testing Uproleselan (GMI-1271), an E-selectin antagonist drug, combined with standard chemotherapy against a placebo plus chemotherapy in patients with relapsed/refractory AML. The goal is to see if Uproleselan improves treatment outcomes compared to the usual approach.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Uproleselan (GMI-1271)Experimental Treatment1 Intervention

Uproleselan in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)

Group II: Placebo (Saline, 0.9% Sodium Chloride)Placebo Group1 Intervention

Placebo in combination with mitoxantrone, etoposide and cytarabine (MEC) or fludarabine, cytarabine and idarubicin (FAI)