Status:
COMPLETED
Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy
Lead Sponsor:
Fred Hutchinson Cancer Center
Conditions:
Adult Acute Megakaryoblastic Leukemia (M7)
Adult Acute Minimally Differentiated Myeloid Leukemia (M0)
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well early discharge and outpatient care works in patients with myelodysplastic syndrome or acute myeloid leukemia previously treated with intensive chemotherapy. Gathe...
Detailed Description
PRIMARY OBJECTIVES: I. Estimate the early death rate in patients discharged after completion of intensive induction or salvage chemotherapy. SECONDARY OBJECTIVES: I. Compare the costs incurred by p...
Eligibility Criteria
Inclusion
- Diagnosis of myelodysplastic syndromes (MDS) or acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12), (promyelocytic leukemia \[PML\]/retinoic acid receptor \[RAR\]), or variants according to the 2008 World Health Organization (WHO) classification
- Currently undergoing AML-like intensive induction or re-induction chemotherapy, or is planned to start such therapy within 1 week
- Provide signed written informed consent
- Patients can be repeatedly enrolled in this protocol (e.g. for induction and 1st or subsequent salvage therapy)
Exclusion
- Drug hypersensitivities or allergies disabling use of prophylactic antimicrobials
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT01235572
Start Date
December 1 2010
End Date
July 1 2014
Last Update
July 31 2020
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109