Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart … (NCT04088903) | Clinical Trial Compass
WithdrawnPhase 1
Study of Daratumumab for Decreasing Circulating Antibodies in Sensitized Patients Awaiting Heart Transplantation
Stopped: Protocol changed to use subcutaneous rather than intravenous daratumumab.
0Started 2021-04-01
Plain-language summary
The purpose of this study is to test whether daratumumab, a drug that eliminates antibody-producing plasma cells, can effectively lower the level of preformed antibodies in patients awaiting heart transplantation. These preformed antibodies limit the number of donor hearts that are compatible for the patients. If daratumumab can effectively remove preformed, donor-specific antibodies, then highly allosensitized patients will have more compatible hearts available to them, potentially decreasing transplant waitlist time and reducing mortality.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participant is on an active list for a heart transplant.
* Participant has a high level of allosensitization, defined as a calculated PRA (panel of reactive antibodies) of 50%, based on their antibody status at the time of entry into the study.
* Ability to understand and willingness to sign an informed consent form prior to any study-related procedures.
* Women of childbearing potential must have a negative pregnancy test at screening.
* Both male and female patients must use effective methods of birth control, must not donate eggs or sperm during the course of the study and for 3 months after stopping daratumumab.
Exclusion Criteria:
* History of allergy or intolerance to daratumumab.
* Prior diagnosis of myeloma or light chain amyloidosis.
* Active infection.
* Women who are pregnant or breastfeeding.
* Ongoing desensitization treatment with another agent. Subjects are excluded if they have received:
* a. IVIG within 30 days of enrollment.
* b. Proteasome inhibitor within 60 days of enrollment.
* c. Rituximab within 180 days of enrollment.
* Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the study or which would, in the opinion of the Investigator, unacceptably increase the subject's risk by participating in the study.
* Contraindication to herpes zoster prophylaxis.
* Known to be seropositive for human immunodeficiency virus (HIV).
* Known to be seropositive for hepatitis B (defined…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the number of individual preformed HLA antibodies before and after daratumumab treatment.
Timeframe: Baseline and Week 12 (or the last measurement prior to heart transplantation, whichever is earlier).