Acute Myeloid Leukemia Clinical Trial

Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia

Summary

This clinical trial studies bioelectrical impedance measurement for predicting treatment outcome in patients with newly diagnosed acute leukemia. Diagnostic procedures, such as bioelectrical impedance measurement, may help predict a patient's response to treatment for acute leukemia.

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Full Description

PRIMARY OBJECTIVES:

I: To determine the feasibility of obtaining standardized phase angle measurements (bioelectrical impedance measurement) on patients hospitalized for treatment of newly diagnosed acute leukemia.

II. To evaluate the association between standardized phase angle measured at the start of therapy and treatment-related outcomes including treatment related mortality (defined as 60-day mortality) III. Evaluate the association of the day 14 standardized phase angle and treatment related outcomes, 30-day mortality, length of hospitalization, transfer to intensive care unit during induction, treatment response (14 day bone marrow response, complete remission), receipt of post-remission therapy, overall survival.

IV. An exploratory analysis investigating associations with the primary and secondary outcomes using different ways to categorize the baseline standardized phase angle and, for acute myeloid leukemia (AML) patients, the standardized phase angle measure obtained just prior to the nadir marrow.

OUTLINE:

Patients undergo bioelectrical impedance phase angle measurement on day 1 of treatment. Patients with AML undergo a second measurement prior to the nadir marrow. Patients also undergo bioelectrical impedance measurements prior to any invasive procedures (bone marrow biopsy, leukapheresis, peripherally inserted central catheter [PICC] line placement, etc.).

After completion of study treatment, patients are followed up for two years.

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Eligibility Criteria

Inclusion Criteria:

Hospitalized for newly diagnosed acute leukemia
Receiving induction treatment while hospitalized
Willing and able to provide written informed consent

Exclusion Criteria:

Presence of a pacemaker or defibrillator
Patients pregnant at the time of enrollment
Any condition or abnormality which may, in the opinion of the investigator, compromise the safety of patients
Unable/unwilling to follow protocol requirements

Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

102

Study ID:

NCT01869777

Recruitment Status:

Completed

Sponsor:

Wake Forest University Health Sciences

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There is 1 Location for this study

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Comprehensive Cancer Center of Wake Forest University
Winston-Salem North Carolina, 27157, United States

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Study is for people with:

Acute Myeloid Leukemia

Estimated Enrollment:

102

Study ID:

NCT01869777

Recruitment Status:

Completed

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

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