Back to resultsPilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)
Primary Purpose
Acute Myeloid Leukemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytosine Arabinoside
Sponsored by
About this trial
This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring Acute myeloid leukemia, outpatient consolidation treatment
Eligibility Criteria
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
Exclusion Criteria:
Exclusion Criteria for All Patients
- Active, uncontrolled viral, bacterial, or fungal infection.
- Documented CNS leukemia.
- If unable to do a reliable cerebellar examination for monitoring of neurotoxicity.
- History of prior autologous or allogeneic bone marrow/stem cell transplant.
- New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease.
- Pregnant or lactating women (women and men of childbearing age should use effective contraception).
- Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.)
- Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy.
- Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.
Sites / Locations
- University of Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Outpatient HiDAC Consolidation
Quality of Life Comparison Group
Arm Description
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.
Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Mean Cost Savings
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02101983
Brief Title
Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)
Official Title
Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
August 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
Acute myeloid leukemia, outpatient consolidation treatment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Outpatient HiDAC Consolidation
Arm Type
Experimental
Arm Description
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.
Arm Title
Quality of Life Comparison Group
Arm Type
Active Comparator
Arm Description
Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Cytosine Arabinoside
Other Intervention Name(s)
AraC, Cytosar U, Cytosine aribinoside, Arabinosylcytosine, Cytarabine sterile, 1-B-Arabinoe-furanosyl-cytosine
Primary Outcome Measure Information:
Title
Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Who Successfully Completed the of Quality of Life Form
Description
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
Title
Mean Cost Savings
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Exclusion Criteria:
Exclusion Criteria for All Patients
Active, uncontrolled viral, bacterial, or fungal infection.
Documented CNS leukemia.
If unable to do a reliable cerebellar examination for monitoring of neurotoxicity.
History of prior autologous or allogeneic bone marrow/stem cell transplant.
New York Heart Association class III/IV congestive heart failure, see appendix 15.4, or active ischemic heart disease.
Pregnant or lactating women (women and men of childbearing age should use effective contraception).
Concomitant active malignancy requiring treatment with cytotoxic chemotherapy or radiation therapy. (Ongoing hormonal therapy for the treatment of malignancy would not exclude patients from this trial.)
Time period of greater than 10 weeks between initiation of induction chemotherapy and day 1 of the first cycle of consolidation chemotherapy.
Patients seropositive for infection with Human Immunodeficiency Virus (HIV) are excluded due to potential for serious infectious complications associated with T-cell suppressive therapy in these patients.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah Mulford, M.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)
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