Trial Outcomes & Findings for Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia (NCT NCT01869777)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

102 participants

Primary outcome timeframe

60 days

Results posted on

2020-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Diagnostic (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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Overall Study STARTED	102
Overall Study COMPLETED	101
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Diagnostic (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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Overall Study Excluded from the analysis, ineligible	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (Bioelectric Impedance Analysis) n=101 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Age, Continuous	62.6 years n=99 Participants
Sex: Female, Male Female	57 Participants n=99 Participants
Sex: Female, Male Male	44 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	97 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=99 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants
Race (NIH/OMB) White	91 Participants n=99 Participants
Race (NIH/OMB) More than one race	0 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants
Region of Enrollment United States	101 participants n=99 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Diagnostic (Bioelectric Impedance Analysis) n=101 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration Alive	91 Participants
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration Deceased	10 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Diagnostic (Bioelectric Impedance Analysis) n=101 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration Alive	95 Participants
Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration Deceased	6 Participants

SECONDARY outcome

Timeframe: Up to 2 years

A linear model will be used to look at the association of standardized phase angle and length of hospital stay.

Outcome measures

Outcome measures
Measure	Diagnostic (Bioelectric Impedance Analysis) n=101 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Length of Hospitalization	34.2 Days Standard Deviation 11.9

SECONDARY outcome

Timeframe: Up to 2 years

Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.

Outcome measures

Outcome measures
Measure	Diagnostic (Bioelectric Impedance Analysis) n=101 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Number of Participants Transferred to Intensive Care Unit During Induction Transferred to ICU	10 Participants
Number of Participants Transferred to Intensive Care Unit During Induction Not transferred to ICU	91 Participants

SECONDARY outcome

Timeframe: 14 days

Population: 14 participants excluded in analysis due to 14-day bone marrow data not available.

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).

Outcome measures

Outcome measures
Measure	Diagnostic (Bioelectric Impedance Analysis) n=87 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Number of Participants With Bone Marrow Response Residual disease	47 Participants
Number of Participants With Bone Marrow Response No residual disease	40 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Diagnostic (Bioelectric Impedance Analysis) n=101 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Number of Participants to Achieve Complete Remission Achieved complete remission	81 Participants
Number of Participants to Achieve Complete Remission Did not achieve complete remission	20 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.

Outcome measures

Outcome measures
Measure	Diagnostic (Bioelectric Impedance Analysis) n=101 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Number of Participants With Receipt of Post-Remission Therapy Receipt of post-remission therapy	79 Participants
Number of Participants With Receipt of Post-Remission Therapy Did not receive post-remission therapy	22 Participants

SECONDARY outcome

Timeframe: Up to 2 years

Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.

Outcome measures

Outcome measures
Measure	Diagnostic (Bioelectric Impedance Analysis) n=101 Participants 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.). bioelectric impedance analysis: Undergo bioelectric impedance analysis
Overall Survival	532 Days Interval 336.0 to 808.0

Adverse Events

Diagnostic (Bioelectric Impedance Analysis)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 16 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal investigator

Wake Forest University Health Sciences

Phone: 336-716-5440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place