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

Study Description

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Brief Summary:

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 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

Detailed Description:

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 Design

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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

Arms and Interventions

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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: 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

Outcome Measures

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Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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).

Eligibility Criteria

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

Criteria

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

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Locations

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)

Investigators

Principal Investigator:	Pamela Becker	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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