Neoplasms

Blood and Lymph Conditions

All Conditions

Rare Diseases

Leukemia

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Neoplasms by Histologic Type

Hematologic Diseases

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Anti-Infective Agents

Antineoplastic Agents

All Drugs and Chemicals

Cytarabine

Antimetabolites

Antiviral Agents

Immunosuppressive Agents

Immunologic Factors

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.

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

Cytosine Arabinoside

Deborah Mulford, M.D.

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.

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.

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

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

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.

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.

University of Rochester

Associate Professor

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.

Cytosine Arabinoside

Outpatient HiDAC Consolidation

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

Cytosine Arabinoside

Quality of Life Comparison Group

Total

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Deborah Mulford

Subjects with a documented unequivocal diagnosis of AML in complete remission, age \>/= 55 years, with good performance status and adequate renal and hepatic function. Subjects who are eligible for standard of care inpatient HiDAC consolidation will be approached to participate in the Quality of Life comparison group.

Number of Participants With Grades 3 to 5 Non-hematologic Toxicity.

Subjects must have an unequivocal diagnosis of AML in a documented complete remission, age \>/= 55 years with a good performance status and adequate renal and hepatic function. Subjects who decline participation as an outpatient will be approached to participate in the quality of life comparison group.

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

Data was not collected from the participants for this outcome measure.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)	NCT02101983	Acute Myeloid L...	Cytosine Arabin...	55 Years - 65 Years	University of Rochester
Pilot Study of Feasibility of Outpatient Daily High Dose Cytarabine as Consolidation Therapy for Older Patients With Acute Myeloid Leukemia (AML)	NCT02101983	Acute Myeloid L...	Cytosine Arabin...	55 Years - 65 Years	University of Rochester

Spots Global Cancer Trial Database for outpatient consolidation treatment