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

NCT02101983 | Completed Results DMC

• 1 other identifier: 35606
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myeloid Leukemia

Keywords

Acute myeloid leukemia; outpatient consolidation treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Participants Who Successfully Completed the of Quality of Life Form

  3 months

• Mean Cost Savings

  3 months

Study Arms (2)

Outpatient HiDAC Consolidation

EXPERIMENTAL

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.

Drug: Cytosine Arabinoside

Quality of Life Comparison Group

ACTIVE COMPARATOR

Patients receiving outpatient intravenous cytarabine will complete the EORTC QLQ-C30 quality of life form on the last day of each cycle of chemotherapy.

Drug: Cytosine Arabinoside

Interventions

Cytosine Arabinoside DRUG

Also known as: AraC, Cytosar U, Cytosine aribinoside, Arabinosylcytosine, Cytarabine sterile, 1-B-Arabinoe-furanosyl-cytosine

Outpatient HiDAC Consolidation; Quality of Life Comparison Group

Eligibility Criteria

• Age: 55 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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
• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Deborah Mulford
• Organization: University of Rochester

deborah_mulford@urmc.rochester.edu

585-275-5823

Study Officials

• Deborah Mulford, M.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: April 2, 2014
• Study Start: May 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: August 1, 2017
• Last Updated: June 27, 2018
• Results First Posted: June 27, 2018

Record last verified: 2018-06

Locations

US (1)