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| Name | Class |
|---|---|
| Notable Labs | INDUSTRY |
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In this study, the investigators will explore the feasibility of ex vivo drug screening to predict sensitivity to chemotherapy resistance and to identify novel synergy between chemotherapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 0 | -A technical run-in of 5 patients with any of the following:
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| Cohort 1 |
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| Cohort 2 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral blood draw | Procedure |
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| Measure | Description | Time Frame |
|---|---|---|
| Determine whether ex vivo drug sensitivity obtained for Day 0 ex vivo treatments for all cohorts as measured by a 384 well high throughput flow-based viability assay correlates with clinical assay | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Ex vivo drug sensitivity obtained for Day 0 ex vivo treatments as measured by a 384 well high throughput flow-based viability assay correlates with molecular responses as measured by founding clone mutation reduction <2% and exome sequencing | 90 days | |
| Determine whether an increase in ex vivo drug resistance on day 2 (cohorts 0 or 1) or day 3 (cohorts 2, 3, 4 and 5), as measured by a 384 well high-throughput flow-based viability assay, correlates with reduced clinical responses |
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Inclusion Criteria:
Acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS)
Peripheral blood blasts > 1%
Peripheral white blood cell count > 1,000/µl.
Age ≥ 18 years
Anticipated treatment with any of the following regimens (Cohort 0) or:
Patients may receive these therapies as part of other on-going clinical trials or as standard of care treatment.
Patients in Cohort 1 may receive SOC midostaurin or gemtuzumab ozogamicin, provided these start after the Day 2 sample is collected. Patients in Cohort 1 may receive a standard combination of cytarabine/idarubicin, cytarabine/daunorubicin, or Vyxeos, a liposomal formulation of cytarabine and daunorubicin.
ECOG performance status ≤ 3
Ability to understand and willingness to sign an IRB approved written informed consent document.
Exclusion Criteria:
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-The study population consists of patients seen at Siteman Cancer Center.
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| Name | Affiliation | Role |
|---|---|---|
| Meagan Jacoby, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Blood, buccal cells, and data will be shared. The researchers may be doing research at Washington University, at other research centers and institutions, or industry sponsors of research. Data may also be shared with large data repositories. The researchers may be doing research in areas similar to this research or in other unrelated areas.
Beginning 3 months and ending 3 years following article publication.
Proposals should be submitted directly to jwelch@wustl.edu.
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| ID | Term |
|---|---|
| D015470 | Leukemia, Myeloid, Acute |
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D007951 | Leukemia, Myeloid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Cohort 3 |
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| Cohort 4 |
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| Cohort 5 |
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| Bone marrow aspirate | Procedure |
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| Buccal swab | Procedure |
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| 90 days |
| Determine whether reduced ex vivo drug sensitivity on day 2 (cohorts 0 or 1) or day 3 (cohorts 2, 3, 4, and 5), as measured by a 384 well high throughput flow-based viability assay, correlates with reduced molecular responses | 90 days |
| Determine whether reduced drug ex vivo drug sensitivity on day 2 (cohorts 0 or 1) or 3 (cohorts 2, 3, 4, and 5), as measured by a 384 well high throughput flow-based viability assay, correlates with reduced disease-free survival | 1 year |
| Determine whether reduced ex vivo drug sensitivity, as measured by a 384 well high throughput flow-based viability assay, correlates with reduced survival | 1 year |
| Determine whether in vivo chemotherapy leads to increased ex vivo sensitivity to any class of drugs in more than 20% of patients treated on any study arm as measured by a 384 well high throughput flow-based viability assay | Day 3 |
| Determine whether decitabine and azacitidine are associated with overlapping or unique profiles in drug sensitivity changes as measured by a 384 well high throughput flow-based viability assay | Day 3 |
| Determine whether ex vivo drug sensitivity, as measured by a 384 well high throughput flow-based viability assay, correlates with the presence of clinically available mutations, as measured by exome sequencing | 90 days |
| Determine whether MDS and AML have overlapping or unique profiles in ex vivo drug sensitivity, as measured by a 384 well high throughput flow-based viability assay | Day 0 |
| Determine whether MDS and AML have overlapping or unique profiles in ex vivo drug sensitivity as measured by a 384 well high throughput flow-based viability assay | Day 3 |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D001855 | Bone Marrow Diseases |