A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor B… (NCT05589896) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
United States12 participantsStarted 2024-08-16
Plain-language summary
The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.
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
. Acute leukemia \[acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)\], MDS without fibrosis, or chronic leukemia (CLL, CML) in the first remission or beyond with ≤5% marrow blasts documented by bone marrow assessment and no circulating blasts or extra-medullary disease within 42 days prior to anticipated start of conditioning
. Chemosensitive non-Hodgkin's lymphomas, Hodgkin's lymphoma, or cutaneous T cell lymphomas in the first remission or beyond documented by PET/CT imaging and bone marrow assessment within 42 days prior to anticipated start of conditioning
. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC)
. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected for hemoglobin.
. Hepatic: total bilirubin ≤2.0 mg/dL, and ALT, AST, and ALP \<3 x upper limit normal (ULN), unless ALT, AST, and/or ALP are disease related
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.
1This trial uses bone marrow from deceased donors that is only partially to fully HLA-matched and has been cryopreserved — how does that approach compare to a standard matched living donor transplant in terms of what's already known about safety and engraftment, and would that difference matter for my specific situation?
2Since this is a Phase 1/2 first-in-human study, the primary outcomes being measured include serious adverse events and death — what does that tell us about how much is still unknown, and how does that risk profile compare to other transplant options available to me right now?
3The trial is no longer actively recruiting new patients — does that mean it's too late to be considered, or are there any circumstances under which my care team could still explore this as an option?
4One of the key things researchers are watching is whether the transplanted cells actually engraft and produce neutrophils — given my specific diagnosis and current health status, how likely would successful engraftment be, and what happens if it doesn't occur?
5Are there standard treatments or other clinical trials I should consider before or instead of this study, especially given that it's still in early phases and the full safety and benefit picture isn't yet established?
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
Neutrophil Engraftment
Timeframe: Day 28
2
Serious Adverse Events
Timeframe: Day 56
3
CTCAE Grade 3/4 Adverse Events (AEs)
Timeframe: Day 56
4
CTCAE Grade 3/4 Adverse Events (AEs) attributed to infusion of Ossium HPC, Marrow
. Renal: SCr within 1.5x normal range for age. If SCr is outside normal range for age, CrCl\> 60 mL/min/1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR)