Haematological MalignancyAMICONCT06814405
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
A study testing Home patient management and Hospital patient management in people with Haematological Malignancy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Haematological Malignancy
- What is being tested?
- Home patient management and Hospital patient management
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 11 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS-AOU di Bologna
Bologna, Bologna, 40138
Pier Luigi Zinzani, MD, +39 0512143680, pierluigi.zinzani@unibo.it
Pier Luigi Zinzani, MD
About this study
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.
Read the detailed description
Patients undergoing particular intensive and (sub)myeloablative chemotherapy regimes with subsequent autologous stem cell transplant currently have a relatively modest rate of therapy-related complications, of infectious and non-infectious (organ damage), relatively modest, thus being able to benefit of a specific multidisciplinary care programme at home. In this clinical context, the early discharge and domicile of the patient after therapy provided in hospital regimen may represent a procedure designed to better intercept the patient's patient's personal needs. In addition, it may make it possible to increase the limited availability of beds against the progressive increase in demand, allowing the provision of hospital treatment to a higher number of patients with a consequent reduction in pre-admission waiting times. The primary objective of the study is to assess the safety and feasibility of the model of early discharge with home continuation of the care pathway of patients haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant.
The secondary objectives are as follows:
- Assessment of the patient's quality of life;
- Evaluation of the impact of the use of innovative remote monitoring technologies;
- Assessment of the optimisation of in-patient places;
- Evaluation of the economic impact.
- Conditions
- Haematological Malignancy
- Being tested
- Home patient management, Hospital patient management
- Keywords
- hospitalisation, early discharge, domiciliation, supportive therapy
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home patient managementProcedure or surgery
with support therapy, Granulocyte growth factor, blood transfusion
Hospital patient managementOther
all procedures and exams needed
| Study group | Role | What they receive |
|---|---|---|
| hospitalized | Active comparator | Hospedalized patients Receives: Other: Hospital patient management |
| early discarged | Experimental | Early discarged patients Receives: Procedure: Home patient management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
safety of the early discharge model with home continuation of the care pathway of haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant
Measured: through the duration of study, an average of 2 years
Number of participants in which will be feasible the early discarge mode
feasibility of the early discharge model with home continuation of the care pathway of haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant
Measured: through the duration of study, an average of 2 years
Secondary outcomes (4)
questionnaire patient's quality of life FACT-An (Functional Assessment of Cancer Therapy) (V. 4, scale 0-4)
Assessment of the patient's quality of life with questionnaire FACT-An(Functional Assessment of Cancer Therapy) (V. 4, scale 0-4) at early discharge and recovery hematology
Measured: through the duration of study, an average of 2 years
Median length of stay with early discharge (outpatient)/median length of hospitalization without early discharge (inpatient) of patients who were enrolled but, for reasons various, were not discharged early;
Median length of stay with early discharge (outpatient)/median length of hospitalization without early discharge (inpatient) of patients who were enrolled but, for reasons various, were not discharged early;
Measured: through the duration of study, an average of 2 years
rate of optimisation of in-patient places
Assessment of optimisation of in-patient places
Measured: through the duration of study, an average of 2 years
Rate of Economic Impact
Economic Impact Assessment
Measured: through the duration of study, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start11 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pier Luigi Zinzani, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814405
- Sponsor's protocol ID
- AMICO
- Other IDs
- AIL Bologna
- Acronym
- AMICO
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2024
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06814405
- Acronym / sponsor ID
- AMICO / AMICO
- Conditions
- Haematological Malignancy
- Keywords
- hospitalisation, early discharge, domiciliation, supportive therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 11 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients undergoing particular intensive and (sub)myeloablative chemotherapy regimes with subsequent autologous stem cell transplant currently have a relatively modest rate of therapy-related complications, of infectious and non-infectious (organ damage), relatively modest, thus being able to benefit of a specific multidisciplinary care programme at home. In this clinical context, the early discharge and domicile of the patient after therapy provided in hospital regimen may represent a procedure designed to better intercept the patient's patient's personal needs. In addition, it may make it possible to increase the limited availability of beds against the progressive increase in demand, allowing the provision of hospital treatment to a higher number of patients with a consequent reduction in pre-admission waiting times. The primary objective of the study is to assess the safety and feasibility of the model of early discharge with home continuation of the care pathway of patients haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant.
The secondary objectives are as follows:
- Assessment of the patient's quality of life;
- Evaluation of the impact of the use of innovative remote monitoring technologies;
- Assessment of the optimisation of in-patient places;
- Evaluation of the economic impact.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hospitalized | Active comparator | Other: Hospital patient managementHospedalized patients |
| early discarged | Experimental | Procedure: Home patient managementEarly discarged patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home patient managementwith support therapy, Granulocyte growth factor, blood transfusion | Procedure or surgery | early discarged |
| Hospital patient managementall procedures and exams needed | Other | hospitalized |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: through the duration of study, an average of 2 years
safety of the early discharge model with home continuation of the care pathway of haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant
Number of participants in which will be feasible the early discarge mode
Time frame: through the duration of study, an average of 2 years
feasibility of the early discharge model with home continuation of the care pathway of haematological patients undergoing high-dose chemotherapy with/without autologous stem cell transplant
4 secondary outcomes
questionnaire patient's quality of life FACT-An (Functional Assessment of Cancer Therapy) (V. 4, scale 0-4)
Time frame: through the duration of study, an average of 2 years
Median length of stay with early discharge (outpatient)/median length of hospitalization without early discharge (inpatient) of patients who were enrolled but, for reasons various, were not discharged early;
Time frame: through the duration of study, an average of 2 years
rate of optimisation of in-patient places
Time frame: through the duration of study, an average of 2 years
Rate of Economic Impact
Time frame: through the duration of study, an average of 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Haematological Malignancy
Not yet recruitingPhase 4
MACE and BTK Inhibitors
Hematologic Cancer, MACE
RecruitingEarly Phase 1
HMCT/CT2401: Abatacept GVHD Prophylaxis Following Omidubicel HCT
Hematologic Malignancy
Recruiting
An Exploratory Study to Evaluate Immune Determinants of the Response to Adoptive Cell Therapy (ACT) in Solid and Hematologic Tumors
Solid Tumor, Adult, Solid Tumor, Childhood
RecruitingObservational study
Natural History Study to Determine Drug Metabolism Phenotype and Appropriate Germline Source DNA in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplant
Leukemia, Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pier Luigi Zinzani, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home patient management and Hospital patient management in people with Haematological Malignancy, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pier Luigi Zinzani, MD (+39 0512143680, pierluigi.zinzani@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: through the duration of study, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2025.