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Complete title: Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
|Research Study Number||8003|
|Principal Investigator||Pamela Becker, MD, PhD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- No other active cancer that requires systemic chemotherapy or radiation
- Significant organ compromise that will increase risk of toxicity or mortality
- Pregnancy or lactation
Other exclusion criteria may apply.
Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia
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