Clinical trial · Interventional
Safety and Feasibility of a Multidisciplinary Programme of Integrated Hospital-home Management With Early Discharge of Patients With Haematological Malignancies Undergoing High-dose Chemotherapy in Hospital
- 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)
Patients undergoing particular intensive and (sub)myeloablative chemotherapy regimens with subsequent autologous stem cell transplant currently have a relatively low rate of therapy-related complications, both infectious and non-infectious (organ damage), and can therefore benefit from a specific multidisciplinary care programme at home. In this clinical context, early discharge and domicile of the patient after therapy provided in a hospital setting may represent a procedure designed to better intercept the patient's personal needs. In addition, it may make it possible to increase the limited availability of beds in the face of the progressive increase in demand, allowing the provision of hospital therapies to a higher number of patients with a consequent reduction in pre-hospital waiting times.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Haematological Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Home patient management | Procedure | — | UNRESOLVED |
| Hospital patient management | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- hospitalized
- description
- Hospedalized patients
- interventionNames
- Other: Hospital patient management
- type
- EXPERIMENTAL
- label
- early discarged
- description
- Early discarged patients
- interventionNames
- Procedure: Home patient management
Primary outcomes (2)
- measure
- Number of participants with treatment-related adverse events
- timeFrame
- through the duration of study, an average of 2 years
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of haematological malignancy undergoing high-dose chemotherapy (sub- or myeloablative) * Age between 18-75 years * WHO Performance Status \< 2 or Karnofsky ≥ 60% * Adequate organ function: * FE≥ 50% and absence of significant electrocardiographic changes * eVFG \> 40 ml/min and/or creatinine ≤ 1.6 mg/dl (CPK-EPI formula) * total bilirubin ≤ 3 mg/ml * AST/ALT ≤ 5 ULN * SpO2 ≥ 94% * Reinfusion ≥ 2x106 CD34+/Kg * Presence of a 24-hour SARS-COV-2 vaccinated caregiver * Home \< 45 minutes' drive from hospital * Informed consent obtained Exclusion Criteria: * Diagnosis of haematological malignancy at onset or in progression * Significant cardiovascular disease: heart failure NYHA class 3 or 4, uncontrolled angina, history of myocardial infarction, unstable angina or stroke in the previous 6 months, uncontrolled hypertension, significant arrhythmias not controlled by medication
References
Publications (0)
Data not yet available