Study to Determine the Efficacy of Uproleselan (GMI-1271) in Combination With Chemotherapy to Treat Relapsed/Refractory Acute Myeloid Leukemia



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:18 - 75
Updated:3/23/2019
Start Date:October 15, 2018
End Date:December 2023
Contact:GlycoMimetics, Inc.
Email:clinicaltrials@glycomimetics.com
Phone:240-243-1201

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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

This study will evaluate the efficacy of uproleselan (GMI-1271), a specific E-selectin
antagonist, in combination with chemotherapy to treat relapsed/refractory AML, compared to
chemotherapy alone. The safety of uproleselan when given with chemotherapy will also be
investigated in patients with relapsed/refractory AML


Inclusion Criteria:

- ≥18 years and ≤75 years in age

- Patients with relapsed or refractory AML

- No more than one prior stem cell transplant

- Has not received the chemotherapy regimen to be used for induction on this trial

- Is considered medically eligible to receive the chemotherapy regimen to be used for
induction on this trial

Exclusion Criteria:

- Patients with acute promyelocytic leukemia, acute leukemia of ambiguous lineage
(biphenotypic leukemia), chronic myeloid leukemia with myeloid blast crisis, or
secondary refractory AML.

- Active signs or symptoms of CNS involvement by malignancy.

- Stem cell transplantation ≤4 months prior to dosing.

- Any immunotherapy or radiotherapy therapy within 28 days of dosing; any other
experimental therapy or chemotherapy within 14 days of dosing.

- Prior use of G-CSF, CM-CSF or plerixafor within 7 days of dosing.

- Inadequate organ function.

- Abnormal liver function.

- Known active infection with hepatitis A, B, or C, or human immunodeficiency virus.

- Moderate kidney dysfunction (glomerular filtration rate <45 mL/min).

- Uncontrolled acute life-threatening bacterial, viral, or fungal infection.

- Clinically significant cardiovascular disease.

- Major surgery within 4 weeks of dosing.
We found this trial at
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sites
Columbus, Ohio 43210
Principal Investigator: Bhavana Bhatnagar, DO
Phone: 614-293-0752
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Anjali Advani, MD
Phone: 216-445-9354
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Jane Liesveld, MD
Phone: 585-275-5295
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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825 Eastlake Ave E
Seattle, Washington 98109
(206) 288-7222
Principal Investigator: Pamela Becker, MD, PhD
Phone: 206-606-1231
Seattle Cancer Care Alliance Seattle Cancer Care Alliance (SCCA) is a cancer treatment center that...
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450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Principal Investigator: Daniel DeAngelo, MD, PhD
Phone: 617-632-2645
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Boston, MA
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11100 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Brenda Cooper, MD
Phone: 216-884-3951
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Durham, North Carolina 27710
Principal Investigator: Harry Erba, MD, PhD
Phone: 919-681-4769
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Durham, NC
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
Principal Investigator: Naval Daver, MD
Phone: 713-794-4392
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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Houston, TX
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Nedlands, Perth
Principal Investigator: Gavin Cull, MBBS, FRACP, DM
Phone: +61 (0)8 6383 3207
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Geoffrey Uy, MD
Phone: 314-747-2449
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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