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

NCT00844441 | Completed

• 5 other identifiers: 2300.00P30CA015704FHCRC-2300.00IR 6845CDR0000631997
• Study Type: interventional
• Target: 96
• Locations: 2 countries
• Sites: 3

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.

Conditions

Leukemia; Myelodysplastic Syndromes

Keywords

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)

Outcome Measures

Primary Outcomes (4)

• Death rate in patients discharged after completion of induction chemotherapy

• Rate of successful discharge of patients who meet medical discharge criteria

• Costs associated with outpatient vs inpatient treatment

• Medical resources used with outpatient vs inpatient treatment

Interventions

medical chart review OTHER

questionnaire administration OTHER

quality-of-life assessment PROCEDURE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Oregon Health and Science University

Portland, Oregon, 97201-3098, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109-1024, United States

Location

Clinical Cancer Research Center at University Hospital Basel

Basel, CH-4031, Switzerland

Location

Related Publications (1)

• Walter RB, Lee SJ, Gardner KM, Chai X, Shannon-Dorcy K, Appelbaum FR, Estey EH. Outpatient management following intensive induction chemotherapy for myelodysplastic syndromes and acute myeloid leukemia: a pilot study. Haematologica. 2011 Jun;96(6):914-7. doi: 10.3324/haematol.2011.040220. Epub 2011 Mar 10.

  PMID: 21393334 DERIVED

MeSH Terms

Conditions

Leukemia; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Monocytic, Acute; Leukemia, Eosinophilic, Acute; Leukemia, Megakaryoblastic, Acute; Leukemia, Basophilic, Acute; Leukemia, Erythroblastic, Acute

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases; Leukemia, Myeloid; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders

Study Officials

• Roland Walter, MD, PhD

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Purpose: HEALTH SERVICES RESEARCH
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 13, 2009
• First Posted: February 16, 2009
• Study Start: December 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: March 1, 2011
• Last Updated: May 19, 2011

Record last verified: 2011-05

Locations

US (2); CH (1)