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

June 1, 2018 updated by: Deborah Mulford, University of Rochester

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

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New York
      • Rochester, New York, United States, 14642
        • University of Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

53 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other Names:
  • Arabinosylcytosine
  • AraC
  • Cytosar U
  • Cytosine aribinoside
  • Cytarabine sterile
  • 1-B-Arabinoe-furanosyl-cytosine
Active Comparator: 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.
Other Names:
  • Arabinosylcytosine
  • AraC
  • Cytosar U
  • Cytosine aribinoside
  • Cytarabine sterile
  • 1-B-Arabinoe-furanosyl-cytosine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.
Time Frame: 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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Successfully Completed the of Quality of Life Form
Time Frame: 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.
3 months
Mean Cost Savings
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Deborah Mulford, M.D., University of Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

October 14, 2013

First Submitted That Met QC Criteria

March 28, 2014

First Posted (Estimate)

April 2, 2014

Study Record Updates

Last Update Posted (Actual)

June 27, 2018

Last Update Submitted That Met QC Criteria

June 1, 2018

Last Verified

June 1, 2018

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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