Status:
COMPLETED
Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
18-60 years
Phase:
NA
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 ...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00844441
Start Date
December 1 2008
End Date
March 1 2011
Last Update
May 19 2011
Active Locations (3)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97201-3098
2
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024
3
Clinical Cancer Research Center at University Hospital Basel
Basel, Switzerland, CH-4031