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
Conditions
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.
Interventions
PROCEDUREbioelectric impedance analysis
Undergo bioelectric impedance analysis
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
| Overall Survival | Up to 2 years | Association between overall survival and standardized phase angle will be evaluated using a Cox proportional hazards model. |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 101 |
| Total | 101 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Excluded from the analysis, ineligible | 1 |
Baseline characteristics
| Characteristic | Diagnostic (Bioelectric Impedance Analysis) |
|---|---|
| Age, Continuous | 62.6 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 97 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 91 Participants |
| Region of Enrollment United States | 101 participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 16 / 101 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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
Time frame: 60 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration | Alive | 91 Participants |
| Diagnostic (Bioelectric Impedance Analysis) | Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration | Deceased | 10 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | Length of Hospitalization | 34.2 Days | Standard Deviation 11.9 |
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
Time frame: Up to 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | Number of Participants to Achieve Complete Remission | Achieved complete remission | 81 Participants |
| Diagnostic (Bioelectric Impedance Analysis) | Number of Participants to Achieve Complete Remission | Did not achieve complete remission | 20 Participants |
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.
Time frame: Up to 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | Number of Participants Transferred to Intensive Care Unit During Induction | Transferred to ICU | 10 Participants |
| Diagnostic (Bioelectric Impedance Analysis) | Number of Participants Transferred to Intensive Care Unit During Induction | Not transferred to ICU | 91 Participants |
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).
Time frame: 14 days
Population: 14 participants excluded in analysis due to 14-day bone marrow data not available.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | Number of Participants With Bone Marrow Response | Residual disease | 47 Participants |
| Diagnostic (Bioelectric Impedance Analysis) | Number of Participants With Bone Marrow Response | No residual disease | 40 Participants |
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.
Time frame: Up to 2 years
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | Number of Participants With Receipt of Post-Remission Therapy | Receipt of post-remission therapy | 79 Participants |
| Diagnostic (Bioelectric Impedance Analysis) | Number of Participants With Receipt of Post-Remission Therapy | Did not receive post-remission therapy | 22 Participants |
Secondary
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
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | Overall Survival | 532 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.
Time frame: 30 days
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Diagnostic (Bioelectric Impedance Analysis) | Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration | Alive | 95 Participants |
| Diagnostic (Bioelectric Impedance Analysis) | Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration | Deceased | 6 Participants |