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This study will evaluate GMI-1271, a specific E-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (Phase I) | Experimental | GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older |
|
| Arm B (Phase II Arm A) | Experimental | GMI-1271 in combination with mitoxantrone, etoposide and cytarabine (MEC) in relapsed/refractory subjects 18 years and older |
|
| Arm C (Phase II Arm B) | Experimental | GMI-1271 in combination with cytarabine and idarubicin (7+3 regimen) in newly diagnosed subjects 60 years and older |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GMI-1271 | Drug | E-selectin antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety assessed by frequency, severity and relatedness of adverse events | up to 44 days |
| Measure | Description | Time Frame |
|---|---|---|
| Time versus plasma concentration profile of GMI-1271 | Plasma concentration of GMI-1271 | up to 11 days |
| Overall response rate | Proportion of subjects who achieve a complete response (CR) or CR with incomplete blood count recovery (CRi) per local investigator assessment |
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Inclusion criteria:
AML (including secondary AML) diagnosed as per WHO criteria
For relapsed/refractory subjects only:
For treatment-naïve subjects only:
ECOG performance status 0-2
Hemodynamically stable and adequate organ function
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel DeAngelo, MD, PhD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis Comprehensive Cancer Center | Sacramento | California | 95817 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34543383 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 28, 2021 | |
| Reset | Oct 26, 2021 | |
| Release | Feb 26, 2024 |
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| Mitoxantrone | Drug | induction chemotherapy |
|
| Etoposide | Drug | induction chemotherapy |
|
| Cytarabine | Drug | induction chemotherapy |
|
| Idarubicin | Drug | induction chemotherapy |
|
| up to 12 months |
| Time to response | Time from date of first dose to first documentation of response | up to 12 months |
| Duration of response | Time from date of first documented remission to the date of relapse or death from any cause, whichever occurs first | up to 12 months |
| Event-free survival | Time from date of first dose to the date of treatment failure, relapse, or death from any cause, whichever occurs first | up to 12 months |
| Overall survival | The probability of survival at 6 months (Phase 1) and 12 months (Phase 2), after the date of first dose of study drug | up to 12 months |
| Dana Farber Cancer Institute |
| Boston |
| Massachusetts |
| 02115 |
| United States |
| University of Michigan, Ann Arbor | Ann Arbor | Michigan | 48109 | United States |
| University of Rochester | Rochester | New York | 14642 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| University of Washington | Seattle | Washington | 98109 | United States |
| Princess Alexandra Hospital | Brisbane | Australia |
| University Hospital Galway | Galway | Ireland |
| Reset | Mar 25, 2024 |
| Release | Jul 23, 2024 |
| Reset | Aug 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 28, 2021 | Oct 26, 2021 | |||
| Feb 26, 2024 | Mar 25, 2024 | |||
| Jul 23, 2024 | Aug 14, 2024 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C000654285 | uproleselan |
| D008942 | Mitoxantrone |
| D005047 | Etoposide |
| D003561 | Cytarabine |
| D015255 | Idarubicin |
| ID | Term |
|---|---|
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
| D011034 | Podophyllotoxin |
| D013764 | Tetrahydronaphthalenes |
| D009281 | Naphthalenes |
| D005960 | Glucosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D000617 | Aminoglycosides |
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