Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Washington
With
National Cancer Institute (NCI)
PRIMARY OBJECTIVES:
I. To obtain results from a high throughput drug sensitivity assay within 10 days, procure drug within 14 days and initiate treatment within 21 days.
SECONDARY OBJECTIVES:
I. To achieve a response (cytoreduction or at least partial response) greater that than expected for comparable refractory patient populations with other salvage regimens.
OUTLINE:
A patient receives a drug intervention based on the results of a high throughput sensitivity assay. This assay best matches a drug to the patient's disease.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria (except acute promyelocytic leukemia), acute leukemias of ambiguous lineage by WHO criteria, or myelodysplastic syndrome refractory anemia with excess blasts (RAEB)-2 by WHO classification or advanced myeloproliferative neoplasm with \>= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML)-2 by WHO classification who have failed 2 inductions at initial diagnosis or failed \>= 2 salvage regimens for relapsed acute myeloid leukemia (AML)
Patients who have had a 1st remission for \>= 1 year must have received cytotoxic chemotherapy as a salvage regimen
Eastern Cooperative Oncology Group (ECOG) performance status 0 - 3
Expectation that we can obtain about 100 million blasts from blood and/or marrow (for example, circulating blast count of 5,000 or greater)
Bilirubin =\< 1.5 x institutional upper limit of normal (IULN) unless elevation is thought to be due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy
Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase \[AST\]) and serum pyruvate glutamate transaminase (SPGT) (alanine aminotransferase \[ALT\]) =\< 2.5 x IULN, unless elevation in thought to be due to hepatic infiltration by the hematologic malignancy
Alkaline phosphatase =\< 2.5 X ULN
Serum creatinine =\< 2.0 mg/dL
Stable or improving on appropriate antimicrobial therapy for infection, without ongoing fever
Informed consent
Willing to use contraception
You may not be if
No other concomitant treatment for leukemia
No other active cancer that requires systemic chemotherapy or radiation
Significant organ compromise that will increase risk of toxicity or mortality
Pregnancy or lactation
Clareo Health | Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
