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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by University of Washington
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT01872819
First received: June 4, 2013
Last updated: September 17, 2014
Last verified: September 2014

June 4, 2013
September 17, 2014
July 2013
April 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Feasibility defined as results from a high throughput drug sensitivity assay within 10 days, procure drug within 14 days and initiate treatment within 21 days [ Time Frame: Up to 21 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01872819 on ClinicalTrials.gov Archive Site
Change in the rate of complete response, defined by criteria of Cheson et al. [ Time Frame: Baseline up to 2 years ] [ Designated as safety issue: No ]
  • Increase the rate of complete response (CR) defined by criteria of Cheson et al. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Degree of cytoreduction defined as the percent cellularity of the bone marrows and the percent leukemia by morphology and flow cytometry [ Time Frame: Within 2-3 weeks of treatment ] [ Designated as safety issue: No ]
  • Disease free survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay

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.

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

OUTLINE:

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • 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
    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
Experimental: Treatment (chemotherapy, biological therapy)
Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.
Interventions:
  • Other: antitumor drug screening assay
  • Drug: chemotherapy
  • Biological: biological therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
Not Provided
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT01872819
8003, NCI-2013-01070, 8003, P30CA015704
No
University of Washington
University of Washington
National Cancer Institute (NCI)
Principal Investigator: Pamela Becker Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
University of Washington
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP