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Leukemia

High Throughput Drug Sensitivity Assay for Selecting Treatment for Relapsed/Refractory AML (8003)
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
Status Conditions Phase Study ID
Recruiting Acute Myeloid Leukemia Pilot 8003
NCT01872819
Summary

This pilot clinical trial studies high throughput sensitivity assay in planning treatment for patients with relapsed or refractory acute myeloid leukemia. Analyzing genes that are in cancer cells may help identify better ways to treat acute myeloid leukemia. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Biological therapies may stimulate the immune system in different ways and stop cancer cells from growing. Giving chemotherapy or biological therapy after analyzing genes may be an effective treatment for acute myeloid leukemia.


Investigator
Pamela Becker, MD, PhD
Location    
Seattle Cancer Care Alliance 800-804-8824  
Eligibility Criteria (must meet the following to participate in this study)
  • Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria (except acute promyelocytic leukemia), 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 AML with duration of 1st remission of less than 1 year
  • 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
Exclusions (conditions that would prevent participation in this study)
  • 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
Last Updated
August 13, 2013
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.