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

NCT ID: NCT02101983

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-08-31

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cytosine Arabinoside

Intervention Type: DRUG

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.

Group Type: ACTIVE_COMPARATOR

Cytosine Arabinoside

Intervention Type: DRUG

Interventions

Cytosine Arabinoside

Intervention Type: DRUG

Other Intervention Names

AraC; Cytosar U; Cytosine aribinoside; Arabinosylcytosine; Cytarabine sterile; 1-B-Arabinoe-furanosyl-cytosine

Eligibility Criteria

Inclusion Criteria

• 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.

• 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

• 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).

• 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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Deborah Mulford

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deborah Mulford, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

35606

Identifier Type: -

Identifier Source: org_study_id