Status:
COMPLETED
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This clinical trial uses a laboratory test called a high throughput sensitivity assay in planning treatment for patients with relapsed or refractory acute myeloid leukemia. The aim is to try to identi...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
August 2 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2014
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01872819
Start Date
August 2 2013
End Date
November 17 2014
Last Update
July 11 2018
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109