N/A
N=17
Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Adult Acute Myeloid Leukemia · Adult Myelodysplastic Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT01807091 ↗Enrolled (actual)
17
Serious AEs
17.7%
Results posted
Mar 2021
Primary outcome: Primary: Rate of Hospital Admission During Outpatient Induction Chemotherapy — 3; 14 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Washington
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Hospital Admission During Outpatient Induction Chemotherapy |
3; 14 | — |
| PRIMARY Death Within 14 Days of Initiating Outpatient Induction Chemotherapy |
— | — |
Summary
This pilot clinical trial studies the feasibility of having induction chemotherapy in an outpatient setting. Patients with acute leukemia (AML) or advanced myelodysplastic syndrome (MDS), at least 18 years of age will be examined. Treating eligible patients with induction chemotherapy in an outpatient setting may save in healthcare cost and improve a patients' quality of life.
Eligibility Criteria
Inclusion Criteria
- Signed written informed consent
- The signed informed consent
- The benefits/risks of the induction chemotherapy regimen will be reviewed, and a second consent may be necessary if the regimen will be administered according to a separate protocol
- AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (10-19% blasts in marrow by morphology or flow cytometry or blood)
- Treatment-related mortality (TRM) score 200
- Afebrile with clear chest imaging and no signs of active viral, bacterial, fungal infection unless determined to be, at the discretion of the investigator, not clinically significant in the context of this study
- Adequate cardiac function as demonstrated by left ventricular ejection fraction (LVEF) of 45% or greater, by multiple gated acquisition (MUGA) or echocardiogram; no ongoing cardiac issues such as uncontrolled arrhythmias or unstable angina or congestive heart failure
- Patient must have an outpatient caregiver available
- Patient must live within 30 minutes of the treating physician's office during outpatient treatment
- Patient must be willing to return to the treating physician's office for outpatient follow-up once outpatient treatment is completed
- Logistical requirements:
- Space available in infusion room
- Outpatient infusion pump available if continuous infusion required
- Case discussed with infusion room nursing staff
Data sourced from ClinicalTrials.gov (NCT01807091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.