An interventional study of bioelectric impedance analysis in Acute Undifferentiated Leukemia, Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities and Adult Acute Myeloid Leukemia With Del(5q), sponsored by Wake Forest University Health Sciences. Completed at 1 site in United States. Per ClinicalTrials.gov, last updated 2020-08-13.
Sponsored by Wake Forest University Health Sciences · Not applicable, Interventional, and Diagnostic
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.
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.
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This study's enrollment of 102 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Exclusion Criteria:
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.).
Procedure: bioelectric impedance analysis
Undergo bioelectric impedance analysis
Also known as: BIA, bioelectric impedance, bioelectric impedance test, bioimpedance analysis
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
Time frame: 60 days
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.
Time frame: 30 days
Length of Hospitalization
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
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.
Time frame: Up to 2 years
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).
Time frame: 14 days
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
Time frame: Up to 2 years
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.
Time frame: Up to 2 years
Overall Survival
Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.
Time frame: Up to 2 years
| Milestone | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Started | 102 |
| Completed | 101 |
| Not completed | 1 |
| Withdrew: Excluded from the analysis, ineligible | 1 |
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
| Participants | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Alive | 91 |
| Deceased | 10 |
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.
| Participants | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Alive | 95 |
| Deceased | 6 |
A linear model will be used to look at the association of standardized phase angle and length of hospital stay.
| Days | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Length of Hospitalization | 34.2 ± 11.9 |
Logistic regression will be used to analyze the association between standardized phase angle and transfer to intensive care unit.
| Participants | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Transferred to ICU | 10 |
| Not transferred to ICU | 91 |
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).
| Participants | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Residual disease | 47 |
| No residual disease | 40 |
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
| Participants | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Achieved complete remission | 81 |
| Did not achieve complete remission | 20 |
Logistic regression will be used to analyze the association between standardized phase angle and receipt of post-remission therapy.
| Participants | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Receipt of post-remission therapy | 79 |
| Did not receive post-remission therapy | 22 |
Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model.
| Days | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Overall Survival | 532 (336 to 808) |
Collected over Up to 2 years to assess for survival only. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | 16/101 (15.8%) | — | — |
| Age, Continuous(years) | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Median | 62.6 (22.9 to 83.8) |
| Sex: Female, Male(Participants) | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Female | 57 |
| Male | 44 |
| Ethnicity (NIH/OMB)(Participants) | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 97 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| American Indian or Alaska Native | 3 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 7 |
| White | 91 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| United States | 101 |
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Wake Forest University Health Sciences