NCT06814405 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
| NCT ID | NCT06814405 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna |
| Condition | Haematological Malignancy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-05-11 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-05-11 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Pier Luigi Zinzani, MD
PRINCIPAL INVESTIGATOR
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Frequently Asked Questions
Who can join the NCT06814405 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Haematological Malignancy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06814405 currently recruiting?
Yes, NCT06814405 is actively recruiting participants. Contact the research team at pierluigi.zinzani@unibo.it for enrollment information.
Where is the NCT06814405 trial being conducted?
This trial is being conducted at Bologna, Italy.
Who is sponsoring the NCT06814405 clinical trial?
NCT06814405 is sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. The principal investigator is Pier Luigi Zinzani, MD at IRCCS Azienda Ospedaliero-Universitaria di Bologna. The trial plans to enroll 100 participants.