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Individualized Treatment for Relapsed/Refractory Acute Leukemia Based on Chemosensitivity and Genomics/Gene Expression Data
This pilot clinical trial studies the feasibility of choosing treatment based on a high throughput ex vivo drug sensitivity assay in combination with mutation analysis for patients with acute leukemia that has returned after a period of improvement (relapsed) or does not respond to treatment (refractory). A high throughput screening assay tests many different drugs individually or in combination that kill leukemia cells in tiny chambers at the same time. High throughput drug sensitivity assay and mutation analysis may help guide the choice most effective for an individual's acute leukemia.
PRIMARY OBJECTIVES: I. To test patient cells in a high throughput assay against individual drugs and drug combinations within 21 days to enable optimal choice of drug combinations for therapy. II. To test gene expression that reveals activation of druggable pathways or mutations in genes that confer susceptibility to specific agents may also be considered in choice of treatment. SECONDARY OBJECTIVE: I. To evaluate the response to the chosen therapy. OUTLINE: Leukemia cells obtained from blood or bone marrow are analyzed for sensitivity to both individual drugs and drug combinations via high throughput chemotherapy sensitivity assay and next generation sequencing assays. Doctors will then recommend chemotherapy regimens based on the results. After completion of the chemotherapy regimen, patients are followed up at 2-4 weeks for response, and then every 3 months for 2 years for duration of response and survival.
Age
3 - No limit years
Sex
ALL
Healthy Volunteers
No
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Start Date
September 11, 2015
Primary Completion Date
June 19, 2020
Completion Date
May 13, 2021
Last Updated
June 30, 2022
34
ACTUAL participants
Chemosensitivity Assay
OTHER
Cytology Specimen Collection Procedure
OTHER
Gene Expression Analysis
GENETIC
Genetic Variation Analysis
GENETIC
In Vitro Sensitivity-Directed Chemotherapy
DRUG
Lead Sponsor
University of Washington
Collaborators
NCT06484062
NCT06222580
Data Source & Attribution
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