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

University of Rochester

Status: Completed

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Cytosine Arabinoside

Study type: Interventional

Funder types: Other

Identifiers

NCT02101983

35606

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 55 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

11 participants in 2 patient groups

Outpatient HiDAC Consolidation

Experimental group

Description:

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.

Treatment:

Drug: Cytosine Arabinoside

Quality of Life Comparison Group

Active Comparator group

Description:

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

Treatment:

Drug: Cytosine Arabinoside