Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00844441
Recruitment Status : Completed
First Posted : February 16, 2009
Last Update Posted : May 19, 2011
National Cancer Institute (NCI)
Information provided by:
Fred Hutchinson Cancer Research Center

Brief Summary:

RATIONALE: Gathering information about patients with myelodysplastic syndrome or acute myeloid leukemia who are discharged after finishing chemotherapy, or who stay in the hospital until blood counts return to normal, may help doctors learn more about a patient's quality of life, use of medical services, and the cost of these services.

PURPOSE: This clinical trial is studying early discharge and outpatient care in patients who have undergone chemotherapy for myelodysplastic syndrome or acute myeloid leukemia.

Condition or disease Intervention/treatment Phase
Leukemia Myelodysplastic Syndromes Other: medical chart review Other: questionnaire administration Procedure: quality-of-life assessment Not Applicable

Detailed Description:



  • 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.


  • 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Primary Purpose: Health Services Research
Official Title: 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
Study Start Date : December 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : March 2011

Primary Outcome Measures :
  1. Death rate in patients discharged after completion of induction chemotherapy
  2. Rate of successful discharge of patients who meet medical discharge criteria
  3. Costs associated with outpatient vs inpatient treatment
  4. Medical resources used with outpatient vs inpatient treatment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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


  • 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


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00844441

United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97201-3098
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
Clinical Cancer Research Center at University Hospital Basel
Basel, Switzerland, CH-4031
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Roland Walter, MD, PhD Fred Hutchinson Cancer Research Center

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Roland Walter, Fred Hutchinson Cancer Research Center Identifier: NCT00844441     History of Changes
Other Study ID Numbers: 2300.00
P30CA015704 ( U.S. NIH Grant/Contract )
IR 6845
CDR0000631997 ( Registry Identifier: PDQ )
First Posted: February 16, 2009    Key Record Dates
Last Update Posted: May 19, 2011
Last Verified: May 2011

Keywords provided by Fred Hutchinson Cancer Research Center:
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)

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Pathologic Processes
Neoplasms by Histologic Type
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions