Home management program for patients with blood cancers after chemotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and feasibility of a multidisciplinary care program that allows patients with haematological malignancies to be discharged early from the hospital and continue their treatment at home. The program targets patients undergoing high-dose chemotherapy and aims to address their personal needs while optimizing hospital bed availability. The study will assess various outcomes, including patient quality of life, the effectiveness of remote monitoring technologies, and the economic impact of this approach.

Why it matters

Who can join: the full rules

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

Where it's running

• IRCCS-AOU di Bologna
  Bologna, Bologna, Italy Recruiting

Study contacts

• Principal investigator: Pier Luigi Zinzani, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Pier Luigi Zinzani, MD
• Email: pierluigi.zinzani@unibo.it
• Phone: +39 0512143680

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.