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Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay

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
Phase       Pilot

Look up trial at NIH

Research Study Description

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 identify drugs that may be effective in killing leukemia cells for those patients who will not be cured with conventional chemotherapy. This assay will test multiple drugs simultaneously against a patient's own donated blood sample. The goal is to use this laboratory assay to best match a drug to a patient's disease.

Eligibility Criteria (must meet the following to participate in this study)

Ages Eligible for Study: 18 Years and older

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 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

Other exclusion criteria may apply.

Research Study Number       8003
Contact       Seattle Cancer Care Alliance Intake Office
Telephone       800-804-8824 / 206-288-1024

Leukemia, Acute Myeloid (AML); Hematologic Malignancies; Leukemia

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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.

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