Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
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ClinicalTrials.gov Identifier: NCT01872819 |
Recruitment Status
:
Active, not recruiting
First Posted
: June 7, 2013
Results First Posted
: April 17, 2017
Last Update Posted
: February 22, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
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 | Not Applicable |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay |
Study Start Date : | July 2013 |
Actual Primary Completion Date : | April 2015 |
Estimated Study Completion Date : | May 2018 |

Arm | Intervention/treatment |
---|---|
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:
Drug: chemotherapy
Patients receive 1 of 160 possible interventions
Other Name: chemo
Biological: biological therapy
Patients receive 1 of 160 possible interventions
|
- 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. Time from sample procurement to assay results.
- Rate of Complete Response, Defined by Criteria of Cheson et al. [ Time Frame: Baseline up to 2 years ]
Number of patients who achieved a Complete Response (CR) with Minimal Residual Disease (MRD), a Complete Response with incomplete hematologic recovery (CRi), or showed reduced blasts in their bone marrow by flow cytometry (Cytoreduction).
Cheson et al. defines a CR as: Bone Marrow blasts <5%, absence of circulating blasts and blasts with Auer rods, absence of extramedullary disease, absolute neutrophil count >1.0 x 10^9/L, and platelet count >100 x 10^9/L. Cheson et al. defines a CRi as: all CR criteria except for residual neutropenia (<1.0 x 10^9/L) or thrombocytopenia (<100 x 10^9/L).

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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872819
United States, Washington | |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | |
Seattle, Washington, United States, 98109 |
Principal Investigator: | Pamela Becker | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium |
Responsible Party: | Pamela S Becker, Principal Investigator, University of Washington |
ClinicalTrials.gov 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 ( U.S. NIH Grant/Contract ) |
First Posted: | June 7, 2013 Key Record Dates |
Results First Posted: | April 17, 2017 |
Last Update Posted: | February 22, 2018 |
Last Verified: | January 2018 |
Additional relevant MeSH terms:
Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute Myelodysplastic Syndromes Preleukemia Leukemia, Myelomonocytic, Acute Leukemia, Myelomonocytic, Chronic Leukemia, Myelomonocytic, Juvenile Anemia, Refractory Myeloproliferative Disorders Anemia, Refractory, with Excess of Blasts |
Myelodysplastic-Myeloproliferative Diseases Leukemia, Monocytic, Acute Leukemia, Megakaryoblastic, Acute Leukemia, Erythroblastic, Acute Neoplasms by Histologic Type Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Anemia Antineoplastic Agents |