Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia
Primary Purpose
Acute Undifferentiated Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q)
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
bioelectric impedance analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Acute Undifferentiated Leukemia
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
Sites / Locations
- Comprehensive Cancer Center of Wake Forest University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (bioelectric impedance analysis)
Arm 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.).
Outcomes
Primary Outcome Measures
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration
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
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration
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
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
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
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
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
Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.
Overall Survival
Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.
Full Information
NCT ID
NCT01869777
First Posted
May 31, 2013
Last Updated
July 30, 2020
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01869777
Brief Title
Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia
Official Title
Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Newly Diagnosed Acute Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
March 19, 2018 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Undifferentiated Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities, Adult Acute Myeloid Leukemia With Del(5q), Adult Acute Myeloid Leukemia With Inv(16)(p13;q22), Adult Acute Myeloid Leukemia With t(15;17)(q22;q12), Adult Acute Myeloid Leukemia With t(16;16)(p13;q22), Adult Acute Myeloid Leukemia With t(8;21)(q22;q22), Mast Cell Leukemia, Myeloid/NK-cell Acute Leukemia, Untreated Adult Acute Lymphoblastic Leukemia, Untreated Adult Acute Myeloid Leukemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (bioelectric impedance analysis)
Arm Type
Experimental
Arm 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.).
Intervention Type
Procedure
Intervention Name(s)
bioelectric impedance analysis
Other Intervention Name(s)
BIA, bioelectric impedance, bioelectric impedance test, bioimpedance analysis
Intervention Description
Undergo bioelectric impedance analysis
Primary Outcome Measure Information:
Title
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration
Description
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
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration
Description
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.
Time Frame
30 days
Title
Length of Hospitalization
Description
A linear model will be used to look at the association of standardized phase angle and length of hospital stay.
Time Frame
Up to 2 years
Title
Number of Participants Transferred to Intensive Care Unit During Induction
Description
Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.
Time Frame
Up to 2 years
Title
Number of Participants With Bone Marrow Response
Description
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).
Time Frame
14 days
Title
Number of Participants to Achieve Complete Remission
Description
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
Time Frame
Up to 2 years
Title
Number of Participants With Receipt of Post-Remission Therapy
Description
Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.
Time Frame
Up to 2 years
Title
Overall Survival
Description
Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.
Time Frame
Up to 2 years
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Timothy Pardee
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Comprehensive Cancer Center of Wake Forest University
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia
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