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Pilot Study of Feasibility, Safety, and Economics of Early Discharge and Outpatient Management of Adult Patients Following Intensive Induction Chemotherapy for Myelodysplastic Syndrome and Non-APL Acute Myeloid Leukemia


N/A
18 Years
60 Years
Not Enrolling
Both
Leukemia, Myelodysplastic Syndromes

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Trial Information

Pilot Study of Feasibility, Safety, and Economics of Early Discharge and Outpatient Management of Adult Patients Following Intensive Induction Chemotherapy for Myelodysplastic Syndrome and Non-APL Acute Myeloid Leukemia


OBJECTIVES:

Primary

- To compare the death rate in patients with myelodysplastic syndromes or acute myeloid
leukemia who are discharged after completion of induction chemotherapy vs those who
remain in the hospital until blood counts recover.

Secondary

- To determine the proportion of patients who meet the early discharge criteria after
completion of induction chemotherapy.

- To compare the costs incurred by patients who are discharged early vs those who are
discharged only after blood counts recover.

- To compare resource utilization (e.g., transfusions) among these patients.

- To compare the quality of life of these patients.

OUTLINE: Within 72 hours after completion of induction chemotherapy, patients are either
discharged from the hospital or remain in the hospital until their blood counts recover.

Patients receive standard supportive care after completion of induction chemotherapy either
in the hospital or as an outpatient. Outpatients are seen by a registered nurse or physician
assistant ≥ 3 times weekly and by a physician at least once weekly.

A medical chart review is conducted to obtain information about medical complications (e.g.,
neutropenic fever, documented infections, bleeding, reasons for hospitalization) and use of
medical resources. Patients complete the MDA Symptom Inventory and the EORTC QLQ-C30
questionnaire periodically to assess quality of life. Costs associated with inpatient and
outpatient care are evaluated using electronic billing information from the University of
Washington Medical Center and Seattle Cancer Care Alliance.

After completion of the study, patients are followed up for 1 month.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of one of the following:

- Myelodysplastic syndromes

- Acute myeloid leukemia (AML)

- No acute promyelocytic leukemia with t(15;17)(q22;q12), PML/RAR, or other
variants

- Planning to undergo AML-like intensive induction chemotherapy (e.g., "7+3" or regimen
with similar or higher intensity) for untreated or relapsed disease within 1 week
after study entry OR has started therapy within the past 72 hours

PATIENT CHARACTERISTICS:

- No hypersensitivity or allergy to fluoroquinolones, triazoles, or acyclovir

- ECOG/WHO/ZUBROD performance status 0-1*

- Total bilirubin ≤ 2.5 times upper limit of normal (ULN) (unless elevation is thought
to be due to Gilbert's syndrome or hemolysis)*

- AST and ALT ≤ 1.5 times ULN*

- Serum creatinine ≤ 1.5 times ULN*

- No clinical evidence of congestive heart failure*

- No active bleeding*

- Not refractory to platelet transfusions (e.g., due to HLA-alloimmunization)*

- No requirement for IV antimicrobial therapy*

- Agrees to undergo close follow-up that includes ≥ 3 visits per week at the Seattle
Cancer Care Alliance (SCCA)*

- Has a confirmed reliable caregiver and transportation*

- Confirmed temporary or permanent residency within a 30-minute commute from the
University of Washington (UW) Medical Center/SCCA*

- Has identified a UW/SCCA hematologist/oncologist who is willing to care for the
patient in the outpatient clinic* NOTE: *Additional criteria for early discharge from
the hospital

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Interventional

Study Design:

Primary Purpose: Health Services Research

Outcome Measure:

Death rate in patients discharged after completion of induction chemotherapy

Safety Issue:

No

Principal Investigator

Roland Walter, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Institutional Review Board

Study ID:

2300.00

NCT ID:

NCT00844441

Start Date:

December 2008

Completion Date:

March 2011

Related Keywords:

  • Leukemia
  • Myelodysplastic Syndromes
  • de novo myelodysplastic syndromes
  • previously treated myelodysplastic syndromes
  • secondary myelodysplastic syndromes
  • recurrent adult acute myeloid leukemia
  • untreated adult acute myeloid leukemia
  • adult acute myeloid leukemia with inv(16)(p13;q22)
  • adult acute myeloid leukemia with t(16;16)(p13;q22)
  • adult acute myeloid leukemia with t(8;21)(q22;q22)
  • adult acute myeloid leukemia with 11q23 (MLL) abnormalities
  • adult acute minimally differentiated myeloid leukemia (M0)
  • adult acute myeloblastic leukemia without maturation (M1)
  • adult acute myeloblastic leukemia with maturation (M2)
  • adult acute myelomonocytic leukemia (M4)
  • adult acute monoblastic leukemia (M5a)
  • adult acute eosinophilic leukemia
  • adult acute monocytic leukemia (M5b)
  • adult acute megakaryoblastic leukemia (M7)
  • adult acute basophilic leukemia
  • acute myeloid leukemia with multilineage dysplasia following myelodysplastic syndrome
  • adult erythroleukemia (M6a)
  • adult pure erythroid leukemia (M6b)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia

Name

Location

Fred Hutchinson Cancer Research CenterSeattle, Washington  98109
Oregon Health and Science UniversityPortland, Oregon  97201