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

Acute Myeloid Leukemia Clinical Trial

Official title:

Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101983
• Other study ID #: 35606
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: August 2017

Study information

• Verified date: June 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 65 Years

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.

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Cytosine Arabinoside

Locations

Country	Name	City	State
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	3 months
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.	3 months
Secondary	Mean Cost Savings		3 months