Actively Recruiting
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
Led by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Updated on 2025-02-07
100
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of haematological malignancy undergoing high-dose chemotherapy (sub- or myeloablative)
- Age between 18-75 years
- WHO Performance Status less than 2 or Karnofsky 60% or higher
- Adequate organ function: ejection fraction 50% or higher and no significant ECG changes
- Estimated glomerular filtration rate above 40 ml/min and/or creatinine 1.6 mg/dl or lower
- Total bilirubin 3 mg/ml or lower
- AST/ALT 5 times upper limit of normal or lower
- Oxygen saturation 94% or higher
- Reinfusion of 2 million CD34+ cells per kg or more
- Presence of a 24-hour SARS-COV-2 vaccinated caregiver
- Home less than 45 minutes' drive from hospital
- Informed consent obtained
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
IRCCS-AOU di Bologna
Bologna, Bologna, Italy, 40138
Actively Recruiting
Research Team
P
Pier Luigi Zinzani, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here