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

Wake Forest University (WFU)

Status: Completed

Conditions: Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Untreated Adult Acute Myeloid Leukemia; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Mast Cell Leukemia; Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Untreated Adult Acute Lymphoblastic Leukemia; Acute Undifferentiated Leukemia; Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With Del(5q); Myeloid/NK-cell Acute Leukemia

Treatments: Procedure: bioelectric impedance analysis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01869777

P30CA012197 (U.S. NIH Grant/Contract)

NCI-2013-00964 (Registry Identifier)

IRB00023374

CCCWFU 99113 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 102 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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102 participants in 1 patient group

Diagnostic (bioelectric impedance analysis)

Experimental group

Description:

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

Treatment:

Procedure: bioelectric impedance analysis