Acute Myeloid Leukemia
Conditions
Keywords
Acute myeloid leukemia, outpatient consolidation treatment
Brief summary
High-dose cytarabine (HiDAC) is considered a standard chemotherapy treatment for patients with acute myeloid leukemia. However, most patients receiving this therapy are required to be admitted to the hospital during their treatment course. The purpose of this study is to compare the safety and cost of high-dose cytarabine treatment given in an in-patient setting versus an out-patient setting.
Detailed description
The primary objective of this study is to: • To determine the incidence of grade 3 to 5 non-hematologic toxicity of high-dose cytarabine (HiDAC) for AML consolidation administered in an outpatient setting. The secondary objectives of this study are to: * To determine cost effectiveness of outpatient HiDAC consolidation versus the standard of care inpatient HiDAC consolidation. * Evaluate patient quality of life (QOL) with this outpatient regimen in comparison to that with the standard inpatient regimen.
Interventions
Sponsors
University of Rochester
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria for Outpatient Administration of HiDAC * Unequivocal diagnosis of AML (\>20% blasts in the bone marrow based on the WHO classification), excluding M3 (acute promyelocytic leukemia). * Documented complete remission (CR) following induction chemotherapy as defined as (18): * Bone marrow with \<5% blasts; absence of blasts with Auer rods * Absolute neutrophil count \>1000/mcL * Platelets \>100,000/mcL * Independence of red cell transfusions * Absence of extramedullary disease * Age ≥ 55 years. * Relapsed AML patients are eligible as long as they meet other inclusion and
Exclusion criteria
. * Good performance status of (ECOG 0-2), see appendix 15.3. * Adequate renal and hepatic function (Cr ≤ 1.2, alkaline phosphatase \<3.0 x upper limit of normal, total bilirubin \<1.5 x upper limit of normal unless there is a history of Gilbert's disease). Inclusion Criteria for Quality of Life Comparison Group * All patients decline to participate as an out-patient or who are not eligible for participation in the out-patient portion of the study will be approached to participate in the QOL comparison. * Age ≥ 18 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Grades 3 to 5 Non-hematologic Toxicity. | 3 months | To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Successfully Completed the of Quality of Life Form | 3 months | Subjects receiving outpatient high dose cytarabine or inpatient high dose cytarabine will complete the European Organization for Research and Treatment of Cancer Quality of Life tool on the last day of each cycle of chemotherapy. It encompasses 5 functional scales, 3 symptom scales and a global health measure. Scores range from 0-100 with higher scores associated with improved quality of life. |
| Mean Cost Savings | 3 months | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Outpatient HiDAC Consolidation Patients will receive 2 cycles of 1.5 grams/m2/day of intravenous cytarabine once daily for six consecutive days. Toxicity will be monitored through the duration of treatment. Observation will be complete upon count recovery and resolution of toxicity after the second cycle.
Cytosine Arabinoside | 5 |
| Quality of Life Comparison Group Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.
Cytosine Arabinoside | 6 |
| Total | 11 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Outpatient HiDAC Consolidation | Quality of Life Comparison Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 6 Participants | 10 Participants |
| Region of Enrollment United States | 5 participants | 6 participants | 11 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 7 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 4 | 0 / 6 |
| serious Total, serious adverse events | 1 / 4 | 0 / 6 |
Outcome results
Primary
Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.
To determine the incidence of number of grades 3 to 5 non-hematologic toxicity of high-dose cytarabine for AML consolidation administered in an outpatient setting.
Time frame: 3 months
Population: Subjects with a documented unequivocal diagnosis of AML in complete remission, age \>/= 55 years, with good performance status and adequate renal and hepatic function. Subjects who are eligible for standard of care inpatient HiDAC consolidation will be approached to participate in the Quality of Life comparison group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outpatient HiDAC Consolidation | Number of Participants With Grades 3 to 5 Non-hematologic Toxicity. | 4 Participants |
| Quality of Life Comparison Group | Number of Participants With Grades 3 to 5 Non-hematologic Toxicity. | 5 Participants |
Secondary
Mean Cost Savings
Time frame: 3 months
Population: Data was not collected from the participants for this outcome measure.
Secondary
Number of Participants Who Successfully Completed the of Quality of Life Form
Subjects receiving outpatient high dose cytarabine or inpatient high dose cytarabine will complete the European Organization for Research and Treatment of Cancer Quality of Life tool on the last day of each cycle of chemotherapy. It encompasses 5 functional scales, 3 symptom scales and a global health measure. Scores range from 0-100 with higher scores associated with improved quality of life.
Time frame: 3 months
Population: Subjects must have an unequivocal diagnosis of AML in a documented complete remission, age \>/= 55 years with a good performance status and adequate renal and hepatic function. Subjects who decline participation as an outpatient will be approached to participate in the quality of life comparison group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Outpatient HiDAC Consolidation | Number of Participants Who Successfully Completed the of Quality of Life Form | 4 Participants |
| Quality of Life Comparison Group | Number of Participants Who Successfully Completed the of Quality of Life Form | 5 Participants |