Clinical trial · Interventional
Early Discharge and Outpatients Care in Patients With Myelodysplastic Syndrome or Acute Myeloid Leukemia Previously Treated With Intensive Chemotherapy
Phase 2 Study of Early Discharge and Outpatient Management of Adult Patients Following Intensive Chemotherapy for MDS and Non-APL AML
- 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 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. 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 the safety of allowing patients to leave the hospital early, the patient's quality of life, use of medical services, and the cost of these services associated with such a policy.
Conditions
Conditions (17)
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 Megakaryoblastic Leukemia (M7) | Adult Acute Megakaryoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Myeloid Leukemia with Minimal Differentiation | ALIAS | 0.90 |
| Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Monocytic Leukemia (M5b) | Adult Acute Monocytic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Adult Acute Myeloblastic Leukemia With Maturation (M2) | Adult Acute Myeloid Leukemia with Maturation | ALIAS | 0.90 |
| Adult Acute Myeloblastic Leukemia Without Maturation (M1) | Adult Acute Myeloid Leukemia without Maturation | ALIAS |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| medical chart review | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| standard follow-up care | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Health services research (early discharge, outpatient care)
- description
- Patients are discharged within 72 hours after completion of chemotherapy and undergo standard outpatient care by a RN, PA, or resident/fellow at a local facility or the study center approximately 3 times per week, as clinically indicated for up to 45 days.
- interventionNames
- Procedure: standard follow-up care
- Other: medical chart review
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Proportion of early deaths among patients who are discharged after completion of induction or salvage chemotherapy
- timeFrame
- Up to day 35
- description
- A one-sided lower exact 95% confidence interval for the proportion of early deaths after discharge will be calculated.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * Drug hypersensitivities or allergies disabling use of prophylactic antimicrobials
References
Publications (0)
Data not yet available