N/A
N=102
Bioelectrical Impedance Measurement for Predicting Treatment Outcome in Patients With Newly Diagnosed Acute Leukemia
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)
Bottom Line
View on ClinicalTrials.gov: NCT01869777 ↗Enrolled (actual)
102
Serious AEs
—
Results posted
Apr 2020
Primary outcome: Primary: Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration — 91; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- bioelectric impedance analysis (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 60 Days After Registration |
91; 10 | — |
| SECONDARY Treatment Related Mortality Defined as the Percent of Patients no Longer Alive at 30 Days After Registration |
95; 6 | — |
| SECONDARY Length of Hospitalization |
34.2 | — |
| SECONDARY Number of Participants Transferred to Intensive Care Unit During Induction |
10; 91 | — |
| SECONDARY Number of Participants With Bone Marrow Response |
47; 40 | — |
| SECONDARY Number of Participants to Achieve Complete Remission |
81; 20 | — |
| SECONDARY Number of Participants With Receipt of Post-Remission Therapy |
79; 22 | — |
| SECONDARY Overall Survival |
532 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01869777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.