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This is the first study of the safety of increasing dose levels of AEB1102 in patients with Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome. The study will also evaluate the amounts of AEB1102 in blood, the effects of AEB1102 on blood amino acid levels and the antitumor effects of AEB1102.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AEB1102 (Co-ArgI-PEG) administered via IV weekly. | Experimental | Co-ArgI-PEG modified human arginase I |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Co-ArgI-PEG modified human arginase I | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Tolerated Dose and Recommended Phase 2 Dose | The dose level at which no more than 1/6 patients experiences dose-limiting toxicity | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Safety profile (changes in physical exam, laboratory measures, reported adverse events) | changes in physical exam, laboratory measures, reported adverse events | 4 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jim Joffrion | Aeglea BioTherapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center at University of Michigan | Ann Arbor | Michigan | 48109 | United States | ||
| Washington University Medical School |
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 10, 2021 | |
| Reset | Jun 2, 2021 | |
| Release | Feb 3, 2022 |
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| St Louis |
| Missouri |
| 63110 |
| United States |
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt-Ingram Cancer Center | Nashville | Tennessee | 37232 | United States |
| Baylor Scott & White | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
| University of Alberta | Edmonton | Alberta | Canada |
| Princess Margaret Cancer Centre | Toronto | Ontario | Canada |
| Jewish General Hospital | Montreal | Quebec | Canada |
| Reset | Feb 25, 2022 |
| Release | Jul 25, 2023 |
| Reset | Aug 15, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 10, 2021 | Jun 2, 2021 | |||
| Feb 3, 2022 | Feb 25, 2022 | |||
| Jul 25, 2023 | Aug 15, 2023 |
| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |
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