Hematologic MalignancyNCT05509439
Home Transfusion for HEME
A study testing Home Transfusion Program Components in people with Hematologic Malignancy, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
The purpose of the research is to assess the feasibility and acceptability of a home blood transfusion program for patients with hematologic malignancies who need blood transfusions Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Home Transfusion Program Components
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 21 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with advanced hematologic malignancies:
- Diagnosis of a hematologic malignancy
- Age ≥ 18 years
- Receipt of primary oncologic care at DFCI (at least 2 outpatient visits in 12 months prior to enrollment)
- Has received at least one red blood cell (RBC) or platelet transfusion since blood cancer diagnosis in the clinic or hospital setting without a serious adverse transfusion reaction
- Physician-estimated prognosis of six months or less
Show all 11Show fewer
- Has an adult informal caregiver that lives in the same residence
- Patient resides within catchment served by Care Dimensions Hospice
- Caregivers:
- Identified informal caregiver of enrolled patient with hematologic malignancy
- Age ≥ 18 years
Who cannot join
- Patients
- Age < 18 years
- Does not have an identified adult informal caregiver who lives in the same residence
- History of previous serious adverse transfusion reaction
- Presence of decompensated congestive heart failure
- Caregiver
Show all 12Show fewer
- Age < 18 years
- Our study will exclude members of the following special populations:
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: A Home Transfusion Program for Patients With Advanced Hematologic Malignancies
The purpose of the research is to assess the feasibility and acceptability of a home blood transfusion program for patients with hematologic malignancies who need blood transfusions
Read the detailed description
This feasibility study will be used to assess the feasibility and acceptability of a hospice-embedded home transfusion program to patients with hematologic malignancies. All enrolled subjects will be patients cared for at Dana Farber Cancer Institute.
This study is a single-arm study of 10 patients with advanced hematologic malignancies who have a limited life-expectancy of six months or fewer and are hospice eligible.
10 Caregivers of enrolled patients will also be invited to participate if interested.
This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed.
Participants will be in the research study for up to six months.
It is expected that about 20 people will take part in this research study.
- Conditions
- Hematologic Malignancy
- Being tested
- Home Transfusion Program Components
- Keywords
- Hematologic Malignancy
- 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 Transfusion Program ComponentsOther
The Home Transfusion Program will include trained transfusion nurse(s) who will administer transfusions in the home setting. The transfusion nurse, who is part of the study team, will work closely with the DFCI/BWH Blood Bank and the hospice agency (Care Dimensions Inc.) that all study patients are enrolled in. The transfusion nurse will administer home transfusions using safe home transfusion practices endorsed by the AABB. The home transfusion program has 4 key aspects Initial home visit, (2) subsequent contact, (3) home transfusion assessment \& administration, (4) usual elements of hospice
| Study group | Role | What they receive |
|---|---|---|
| Home Transfusion | Experimental | This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed.
* Home Transfusion Program Components
* Participants will be in the research study for up to six months Receives: Other: Home Transfusion Program Components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment Rate
Number of patients consented to the study divided by eligible patients approached by the study team
Measured: 6 months
Completion of Home Transfusions and Patient-Reported Data
Proportion of completed home transfusions among enrolled patients who meet transfusion criteria, and proportion of enrolled patients who complete patient-reported data collection
Measured: 6 months
Secondary outcomes (2)
Satisfaction Rate
Proportion of enrolled patients who are satisfied with the home transfusion program and proportion of enrolled patients who are likely to recommend the home transfusion program.
Measured: 3 Weeks
Disenrollment Rate
Proportion of study participants who disenroll from the study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start18 Oct 2024
- Primary completion13 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oreofe Odejide, MD, Dana-Farber Cancer Institute
- Investigators
- Oreofe O Odejide, MD, MPH, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05509439
- Sponsor's protocol ID
- 22-178
- Status last verified
- Sep 2025
- First submitted
- 18 Aug 2022
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Home Transfusion Program for Patients With Advanced Hematologic Malignancies
- ClinicalTrials.gov ID
- NCT05509439
- Acronym / sponsor ID
- 22-178
- Conditions
- Hematologic Malignancy
- Keywords
- Hematologic Malignancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 13 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 22 Aug 2022 (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.
The purpose of the research is to assess the feasibility and acceptability of a home blood transfusion program for patients with hematologic malignancies who need blood transfusions
Detailed description
This feasibility study will be used to assess the feasibility and acceptability of a hospice-embedded home transfusion program to patients with hematologic malignancies. All enrolled subjects will be patients cared for at Dana Farber Cancer Institute.
This study is a single-arm study of 10 patients with advanced hematologic malignancies who have a limited life-expectancy of six months or fewer and are hospice eligible.
10 Caregivers of enrolled patients will also be invited to participate if interested.
This research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed.
Participants will be in the research study for up to six months.
It is expected that about 20 people will take part in this research study.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Home Transfusion | Experimental | Other: Home Transfusion Program ComponentsThis research study involves completing questionnaires, a brief interview, blood draws, and blood transfusions when needed. * Home Transfusion Program Components * Participants will be in the research study for up to six months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with advanced hematologic malignancies:
- Caregivers:
Key exclusion criteria (12 listed)
- Patients
- Caregiver
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 Transfusion Program ComponentsThe Home Transfusion Program will include trained transfusion nurse(s) who will administer transfusions in the home setting. The transfusion nurse, who is part of the study team, will work closely with the DFCI/BWH Blood Bank and the hospice agency (Care Dimensions Inc.) that all study patients are enrolled in. The transfusion nurse will administer home transfusions using safe home transfusion practices endorsed by the AABB. The home transfusion program has 4 key aspects Initial home visit, (2) subsequent contact, (3) home transfusion assessment \& administration, (4) usual elements of hospice | Other | Home Transfusion |
Primary outcome
Enrollment Rate
Time frame: 6 months
Number of patients consented to the study divided by eligible patients approached by the study team
Completion of Home Transfusions and Patient-Reported Data
Time frame: 6 months
Proportion of completed home transfusions among enrolled patients who meet transfusion criteria, and proportion of enrolled patients who complete patient-reported data collection
2 secondary outcomes
Satisfaction Rate
Time frame: 3 Weeks
Disenrollment Rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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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. This study is not recruiting at the moment.
Oreofe O Odejide, MD, MPH principal investigator
Dana-Farber Cancer Institute
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 Transfusion Program Components in people with Hematologic Malignancy, run by Dana-Farber Cancer Institute at 1 site in United States.
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 11 inclusion and 12 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: finished, as of the sponsor's last update on 25 Sep 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment Rate (time frame: 6 months). 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 25 Sep 2025.