Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
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|ClinicalTrials.gov Identifier: NCT01807091|
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : March 5, 2021
Last Update Posted : March 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Adult Acute Myeloid Leukemia Adult Myelodysplastic Syndrome||Drug: Chemotherapy||Not Applicable|
Assess the feasibility of outpatient induction therapy for acute myeloid leukemia (AML) or advanced myelodysplastic syndrome (MDS) by examining whether:
- > 50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
- < 5% of patients die within 14 days of beginning outpatient chemotherapy.
Patients receive outpatient induction chemotherapy.
The study was monitored to assure that there was not an excess probability of admission to the hospital during receipt of outpatient chemotherapy or death within 14 days of initiating chemotherapy as assessed by Bayesian posterior probabilities using the "predictive probabilities" tool (MD Anderson Cancer Center Department of Statistics).
Stopping earlier would happen under 2 circumstances:
- Excess probability that patients required admission to hospital during the 4-7 days of outpatient chemotherapy (predictive probability be < 0.10, or 7 patients admitted and 3 not admitted among 10 patients enrolled versus the maximum acceptable rate of 4 patients admitted and 6 not admitted among 10 patients enrolled).
- Excess probability that patients die during the 14 days after beginning outpatient treatment (predictive probability be >0.90, for example in cases where there are 2 patient deaths within 14 days and less than 5 patients without deaths within 14 days, or in any case where there are 3 patient deaths within 14 days).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||17 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome|
|Actual Study Start Date :||May 21, 2013|
|Actual Primary Completion Date :||January 8, 2020|
|Actual Study Completion Date :||January 8, 2020|
Experimental: Treatment (chemotherapy)
Participants received intensive initial or salvage induction chemotherapy regimens. These regimens would usually be administered in the inpatient setting, however participants received them outpatient. This study did not dictate the choice of induction chemotherapy regimen. The regimen was decided upon by patient and their treating oncologist and clinical care team. The induction chemotherapy regimens administrations spanned 4-7 days.
Receive outpatient induction chemotherapy
- Rate of Hospital Admission During Outpatient Induction Chemotherapy [ Time Frame: During the 4-7 days of outpatient induction chemotherapy ]Feasibility for this study objective would be considered a "success" if >50% of patients treated as outpatients can complete chemotherapy without being admitted to hospital.
- Death Within 14 Days of Initiating Outpatient Induction Chemotherapy [ Time Frame: During the 14 days after beginning outpatient induction treatment ]Feasibility for this study objective would be considered a "success" if <5% of patients die within 14 days of beginning outpatient chemotherapy.
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 ClinicalTrials.gov identifier (NCT number): NCT01807091
|United States, Montana|
|Bozeman Deaconess Hospital|
|Bozeman, Montana, United States, 59715|
|United States, Washington|
|Kadlec Clinic Hematology and Oncology|
|Kennewick, Washington, United States, 99336|
|EvergreenHealth Medical Center|
|Kirkland, Washington, United States, 98033|
|Skagit Valley Hospital|
|Mount Vernon, Washington, United States, 98274|
|Olympic Medical Center|
|Port Angeles, Washington, United States, 98362|
|Group Health Cooperative|
|Redmond, Washington, United States, 98052|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Multicare Health System|
|Tacoma, Washington, United States, 98415|
|Wenatchee Valley Hospital and Clinics|
|Wenatchee, Washington, United States, 98801|
|Principal Investigator:||Pamela Becker||Fred Hutch/University of Washington Cancer Consortium|
|Principal Investigator:||Eli Estey||Fred Hutch/University of Washington Cancer Consortium|