Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study is ongoing, but not recruiting participants.
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Pamela S Becker, University of Washington Identifier:
First received: June 4, 2013
Last updated: March 4, 2017
Last verified: March 2017
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.

Condition Intervention
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Adult Acute Monoblastic Leukemia (M5a)
Adult Acute Monocytic Leukemia (M5b)
Adult Acute Myeloblastic Leukemia With Maturation (M2)
Adult Acute Myeloblastic Leukemia Without Maturation (M1)
Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities
Adult Acute Myeloid Leukemia With Del(5q)
Adult Acute Myeloid Leukemia With Inv(16)(p13;q22)
Adult Acute Myeloid Leukemia With t(16;16)(p13;q22)
Adult Acute Myeloid Leukemia With t(8;21)(q22;q22)
Adult Acute Myelomonocytic Leukemia (M4)
Adult Erythroleukemia (M6a)
Adult Pure Erythroid Leukemia (M6b)
Chronic Myelomonocytic Leukemia
Myelodysplastic/Myeloproliferative Neoplasm, Unclassifiable
Previously Treated Myelodysplastic Syndromes
Recurrent Adult Acute Myeloid Leukemia
Refractory Anemia With Excess Blasts
Other: antitumor drug screening assay
Drug: chemotherapy
Biological: biological therapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay

Resource links provided by NLM:

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Achievability of Performing Individualized Drug Screening and Initiating Therapy Based on the Results of the Drug Screen for Poor Risk Patients With Relapsed or Refractory AML [ Time Frame: Up to 21 days ]
    Whether treatment was administered in the time frame based on the high throughput drug screen.

Secondary Outcome Measures:
  • Change in the Rate of Complete Response, Defined by Criteria of Cheson et al. [ Time Frame: Baseline up to 2 years ]

Enrollment: 15
Study Start Date: July 2013
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (chemotherapy, biological therapy)
Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.
Other: antitumor drug screening assay
Undergo high throughput drug sensitivity assay
Other Names:
  • antitumor drug screening assays
  • drug screening assays, antitumor
Drug: chemotherapy
Patients receive 1 of 160 possible interventions
Other Name: chemo
Biological: biological therapy
Patients receive 1 of 160 possible interventions

Detailed Description:


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.


I. To achieve a response (cytoreduction or at least partial response) greater that than expected for comparable refractory patient populations with other salvage regimens.


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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01872819

United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Pamela Becker Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

Responsible Party: Pamela S Becker, Principal Investigator, University of Washington Identifier: NCT01872819     History of Changes
Other Study ID Numbers: 8003
NCI-2013-01070 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
8003 ( Other Identifier: Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium )
P30CA015704 ( US NIH Grant/Contract Award Number )
Study First Received: June 4, 2013
Results First Received: March 4, 2017
Last Updated: March 4, 2017

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Leukemia, Myelomonocytic, Chronic
Anemia, Refractory
Myeloproliferative Disorders
Leukemia, Myelomonocytic, Acute
Anemia, Refractory, with Excess of Blasts
Myelodysplastic-Myeloproliferative Diseases
Leukemia, Monocytic, Acute
Leukemia, Megakaryoblastic, Acute
Leukemia, Erythroblastic, Acute
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Antineoplastic Agents processed this record on May 22, 2017