Study to Determine Safety, Pharmacokinetics and Efficacy of GMI-1271 in Combination With Chemotherapy in AML
NCT ID: NCT02306291
Last Updated: 2019-05-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
91 participants
INTERVENTIONAL
2015-03-31
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm A (Phase I)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
GMI-1271
E-selectin antagonist
Mitoxantrone
induction chemotherapy
Etoposide
induction chemotherapy
Cytarabine
induction chemotherapy
Arm B (Phase II Arm A)
GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older
GMI-1271
E-selectin antagonist
Mitoxantrone
induction chemotherapy
Etoposide
induction chemotherapy
Cytarabine
induction chemotherapy
Arm C (Phase II Arm B)
GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older
GMI-1271
E-selectin antagonist
Cytarabine
induction chemotherapy
Idarubicin
induction chemotherapy
Interventions
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GMI-1271
E-selectin antagonist
Mitoxantrone
induction chemotherapy
Etoposide
induction chemotherapy
Cytarabine
induction chemotherapy
Idarubicin
induction chemotherapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. For relapsed/refractory subjects only:
* Subjects age ≥ 18 years with relapsed or refractory AML after ≤ 2 prior induction regimens, at least one containing anthracyclines
* Medically eligible to receive MEC
* Absolute blast count (ABC) ≤ 40,000/mm
3. For treatment-naïve subjects only:
* Subjects ≥ 60 years of age with newly diagnosed AML
* Medically eligible to receive "7+3" cytarabine/idarubicin
* ABC count ≤ 40,000/mm
4. ECOG performance status 0-2
5. Hemodynamically stable and adequate organ function
Exclusion Criteria
2. Acute leukemia of ambiguous lineage (biphenotypic leukemia)
3. Active signs or symptoms of CNS involvement by malignancy
4. No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
5. Known history or evidence of active hepatitis A, B, or C or HIV
6. Uncontrolled acute life threatening bacterial, viral or fungal infection
7. Active graft versus host disease (GVHD) ≥ Grade 2 or extensive chronic GVHD requiring immunosuppressive therapy
8. Hematopoietic stem cell transplantation ≤ 4 months of dosing
9. Clinically significant cardiovascular disease
18 Years
ALL
No
Sponsors
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GlycoMimetics Incorporated
INDUSTRY
Responsible Party
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Principal Investigators
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Daniel DeAngelo, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
University of Michigan, Ann Arbor
Ann Arbor, Michigan, United States
University of Rochester
Rochester, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Washington
Seattle, Washington, United States
Princess Alexandra Hospital
Brisbane, , Australia
University Hospital Galway
Galway, , Ireland
Countries
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References
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DeAngelo DJ, Jonas BA, Liesveld JL, Bixby DL, Advani AS, Marlton P, Magnani JL, Thackray HM, Feldman EJ, O'Dwyer ME, Becker PS. Phase 1/2 study of uproleselan added to chemotherapy in patients with relapsed or refractory acute myeloid leukemia. Blood. 2022 Feb 24;139(8):1135-1146. doi: 10.1182/blood.2021010721.
Other Identifiers
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GMI-1271-201
Identifier Type: -
Identifier Source: org_study_id
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