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

Not Applicable

Completed

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

• Registration Number: NCT01869777
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-05-31
• Study First Submitted QC: 2013-05-31
• Study First Posted: 2013-06-05
• Study Start: 2013-07
• Primary Completion: 2018-03-19
• Results First Submitted: 2020-02-28
• Results First Submitted QC: 2020-04-14
• Results First Posted: 2020-04-27
• Status Verified: 2020-05
• Study Completion: 2020-05
• Last Update Submitted: 2020-07-30
• Last Update Posted: 2020-08-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (bioelectric impedance analysis)	bioelectric impedance analysis	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.).

Primary Outcome Measures

Name	Time	Method
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration	60 days	Logistic regression will be used to analyze the association between standardized phase angle and 60 day mortality. 60 day mortality rate is defined as the percent of patients no longer alive at 60 days after registration. Patients that are discharged to hospice care before 60 days without a known date of death will be counted towards 60 day mortality

Secondary Outcome Measures

Name	Time	Method
Overall Survival	Up to 2 years	Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration	30 days	Logistic regression will be used to analyze the association between standardized phase angle and 30 day mortality. 30 day mortality rate is defined as the percent of patients no longer alive at 30 days after registration.
Length of Hospitalization	Up to 2 years	A linear model will be used to look at the association of standardized phase angle and length of hospital stay.
Number of Participants Transferred to Intensive Care Unit During Induction	Up to 2 years	Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.
Number of Participants With Bone Marrow Response	14 days	Logistic regression will be used to analyze the significant association between standardized phase angle and marrow response at 14-day bone marrow biopsy to show the odds of having 14-day residual disease (presence cancer cells remaining after treatment) and non-residual disease (no cancer cells remaining after treatment). (14 day bone marrow response is defined as hypoplastic marrow with less than 20% cellularity and 5% blasts. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count \>1000, platelet count \>100,000 and freedom from red cell transfusions).
Number of Participants to Achieve Complete Remission	Up to 2 years	Logistic regression will be used to analyze the association between standardized phase angle and complete remission. Complete remission is defined as less than 5% marrow blasts, absolute neutrophil count \> 1000, platelet count \> 100,000 and freedom from red cell transfusions
Number of Participants With Receipt of Post-Remission Therapy	Up to 2 years	Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States