Clinical trial NCT01869777: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-06-05
Enrollment: 102
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration
timeFrame: 60 days
Secondary outcomes:
measure: Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration
timeFrame: 30 days
measure: Length of Hospitalization
timeFrame: Up to 2 years
measure: Number of Participants Transferred to Intensive Care Unit During Induction
timeFrame: Up to 2 years
measure: Number of Participants With Bone Marrow Response
timeFrame: 14 days
measure: Number of Participants to Achieve Complete Remission
timeFrame: Up to 2 years
measure: Number of Participants With Receipt of Post-Remission Therapy
timeFrame: Up to 2 years
measure: Overall Survival
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Timothy Pardee
role: PRINCIPAL_INVESTIGATOR
References: