Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)

Not Applicable

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Outpatient HiDAC Consolidation	Cytosine Arabinoside	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.
Quality of Life Comparison Group	Cytosine Arabinoside	Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Locations (1): University of Rochester
🇺🇸
Rochester, New York, United States