Clinical trial · Interventional
Early Discharge and Outpatient Care After Chemotherapy in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia
Pilot Study of Feasibility, Safety, and Economics of Early Discharge and Outpatient Management of Adult Patients Following Intensive Induction Chemotherapy for Myelodysplastic Syndrome and Non-APL Acute Myeloid Leukemia
- 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)
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 return to normal, may help doctors learn more about a patient's quality of life, use of medical services, and the cost of these services. PURPOSE: This clinical trial is studying early discharge and outpatient care in patients who have undergone chemotherapy for myelodysplastic syndrome or acute myeloid leukemia.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| medical chart review | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Death rate in patients discharged after completion of induction chemotherapy
- measure
- Rate of successful discharge of patients who meet medical discharge criteria
- measure
- Costs associated with outpatient vs inpatient treatment
- measure
- Medical resources used with outpatient vs inpatient treatment
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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 CharacteristicsReferences
Publications (1)
- DERIVEDWalter RB, Lee SJ, Gardner KM, Chai X, Shannon-Dorcy K, Appelbaum FR, Estey EH. Outpatient management following intensive induction chemotherapy for myelodysplastic syndromes and acute myeloid leukemia: a pilot study. Haematologica. 2011 Jun;96(6):914-7. doi: 10.3324/haematol.2011.040220. Epub 2011 Mar 10. PMID 21393334