Clinical trial NCT02101983: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myeloid Leukemia
Keywords: Acute myeloid leukemia
outpatient consolidation treatment
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 11
Sex: ALL
Minimum age (years): 55
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: 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.

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.

Primary outcomes:
measure: Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.
timeFrame: 3 months
Secondary outcomes:
measure: Number of Participants Who Successfully Completed the of Quality of Life Form
timeFrame: 3 months
measure: Mean Cost Savings
timeFrame: 3 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Deborah Mulford, M.D.
role: PRINCIPAL_INVESTIGATOR
References: