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

Recruiting now · Not applicable

Conditions studied: Haematological Malignancy

In brief

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.

Key facts

Study ID

NCT06814405

Run by

IRCCS Azienda Ospedaliero-Universitaria di Bologna

People needed

100

Starts

2023-05-11

Expected to finish

2025-12-31

Last updated by the study team

2025-02-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• IRCCS-AOU di Bologna — Bologna, Bologna, Italy (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.