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

Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities Clinical Trial

Official title:

Investigating the Prognostic Importance of Bioelectrical Impedance Phase Angle in Adults Treated for Newly Diagnosed Acute Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01869777
• Other study ID #: IRB00023374
• Secondary ID: NCI-2013-00964P3
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: May 2020

Study information

• Verified date: May 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 2020
• Est. primary completion date: March 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Disease
• 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)
• Leukemia
• Leukemia, Mast-Cell
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Mast Cell Leukemia
• Myeloid/NK-cell Acute Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Untreated Adult Acute Lymphoblastic Leukemia
• Untreated Adult Acute Myeloid Leukemia

Intervention

Procedure:
• bioelectric impedance analysis
Undergo bioelectric impedance analysis

Locations

Country	Name	City	State
United States	Comprehensive Cancer Center of Wake Forest University	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	60 days
Secondary	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.	30 days
Secondary	Length of Hospitalization	A linear model will be used to look at the association of standardized phase angle and length of hospital stay.	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	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).	14 days
Secondary	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	Up to 2 years
Secondary	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.	Up to 2 years
Secondary	Overall Survival	Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.	Up to 2 years