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Treatment for Relapsed/Refractory AML Based on a High Throughput Drug Sensitivity Assay | Clinical Trials | Clareo Health

COMPLETEDNA

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

NCT01872819•University of Washington

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

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
+1 more criteria

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

Locations (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Key Dates

Start Date

August 2, 2013

Primary Completion Date

November 1, 2014

Completion Date

November 17, 2014

Last Updated

July 11, 2018

Enrollment

ACTUAL participants

Conditions

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) AbnormalitiesAdult 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 LeukemiaMyelodysplastic/Myeloproliferative Neoplasm, UnclassifiablePreviously Treated Myelodysplastic SyndromesRecurrent Adult Acute Myeloid LeukemiaRefractory Anemia With Excess Blasts

Interventions

antitumor drug screening assay

OTHER

chemotherapy

DRUG

biological therapy

BIOLOGICAL

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COMPLETEDPHASE2

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Lenalidomide in Treating Older Patients With Acute Myeloid Leukemia

Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy

Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies

Bortezomib and Combination Chemotherapy in Treating Younger Patients With Recurrent, Refractory, or Secondary Acute Myeloid Leukemia

Bortezomib in Treating Patients With High-Risk Acute Myeloid Leukemia in Remission

Decitabine Followed by Idarubicin and Cytarabine in Treating Patients With Relapsed or Refractory AML and MDS