Clinical trial · Interventional
Outpatient Induction Chemotherapy in Treating Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
Feasibility of Outpatient Induction Chemotherapy for Adult Patients With Acute Myeloid Leukemia or Advanced Myelodysplastic Syndrome
NCT01807091CI-TRIAL-00050509completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adult Acute Myeloid Leukemia | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Adult Myelodysplastic Syndrome | Adult Myelodysplastic Syndrome | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (chemotherapy)
- description
- 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.
- interventionNames
- Drug: Chemotherapy
Primary outcomes (2)
- measure
- Rate of Hospital Admission During Outpatient Induction Chemotherapy
- timeFrame
- During the 4-7 days of outpatient induction chemotherapy
- description
- 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.
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 \< 9.21 corresponding to a TRM rate of 3% when chemotherapy of similar intensity as proposed here is administered to inpatients * Blast count =\< 10,000 * Fibrinogen \> 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
References
Publications (0)
Data not yet available
No reference posted for this study.