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

Primary Purpose

Adult Acute Megakaryoblastic Leukemia (M7), Adult Acute Minimally Differentiated Myeloid Leukemia (M0), Adult Acute Monoblastic Leukemia (M5a)

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
antitumor drug screening assay
chemotherapy
biological therapy
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adult Acute Megakaryoblastic Leukemia (M7)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (chemotherapy, biological therapy)

Arm Description

Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.

Outcomes

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
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

Rate of Complete Response, Defined by Criteria of Cheson et al.
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).

Full Information

First Posted
June 4, 2013
Last Updated
June 13, 2018
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01872819
Brief Title
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
Official Title
Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2, 2013 (Actual)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 17, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (chemotherapy, biological therapy)
Arm Type
Experimental
Arm Description
Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.
Intervention Type
Other
Intervention Name(s)
antitumor drug screening assay
Other Intervention Name(s)
antitumor drug screening assays, drug screening assays, antitumor
Intervention Description
Undergo high throughput drug sensitivity assay
Intervention Type
Drug
Intervention Name(s)
chemotherapy
Other Intervention Name(s)
chemo
Intervention Description
Patients receive 1 of 160 possible interventions
Intervention Type
Biological
Intervention Name(s)
biological therapy
Intervention Description
Patients receive 1 of 160 possible interventions
Primary Outcome Measure Information:
Title
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
Description
Whether treatment was administered in the time frame based on the high throughput drug screen. Time from sample procurement to assay results.
Time Frame
Up to 21 days
Secondary Outcome Measure Information:
Title
Rate of Complete Response, Defined by Criteria of Cheson et al.
Description
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).
Time Frame
Baseline up to 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pamela Becker
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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

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