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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Washington

Current Primary Outcome: 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.


Original Primary Outcome: Feasibility defined as results from a high throughput drug sensitivity assay within 10 days, procure drug within 14 days and initiate treatment within 21 days [ Time Frame: Up to 21 days ]

Current Secondary Outcome: Change in the Rate of Complete Response, Defined by Criteria of Cheson et al. [ Time Frame: Baseline up to 2 years ]

Original Secondary Outcome:

  • Increase the rate of complete response (CR) defined by criteria of Cheson et al. [ Time Frame: Up to 2 years ]
  • Degree of cytoreduction defined as the percent cellularity of the bone marrows and the percent leukemia by morphology and flow cytometry [ Time Frame: Within 2-3 weeks of treatment ]
  • Disease free survival [ Time Frame: Up to 2 years ]
  • Overall survival [ Time Frame: Up to 2 years ]


Information By: University of Washington

Dates:
Date Received: June 4, 2013
Date Started: July 2013
Date Completion:
Last Updated: March 4, 2017
Last Verified: March 2017