Could dead donors provide Life-Saving bone marrow?
NCT ID NCT05589896
First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 4 times
Summary
This early study is testing whether bone marrow from deceased donors can be safely used for transplants in people with blood cancers like leukemia and lymphoma. Twelve patients will receive the transplant along with chemotherapy or radiation. The main goal is to see if the new marrow starts making blood cells and to check for serious side effects over the first year.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bone marrow from a deceased donor
- What this could lead to
- If successful, this could provide a new source of bone marrow for transplants, potentially helping more patients with blood cancers who lack a living donor.
- What could go wrong
- This is a very early, small trial (12 people) focused on safety. The approach may fail to engraft or cause serious side effects, and it's unknown if it will work as well as standard living-donor transplants.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Aug 2024
- Expected to finish
-
May 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements * Male or female, aged ≥18 and ≤65 years for patients receiving MAC (Regimen A or Regimen B); aged ≥18 and ≤75 years for patients receiving RIC (Regimen C or D) * Patient must require allogeneic HCT per the discretion of the treating physician * Patient must be high-resolution, HLA partially or fully matched (4-8/8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product * Stated willingness to comply with all study procedures and availability for the duration of the study * Diagnosed with malignant hematologic disease including: 1. 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 2. 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 * Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC) * HCT comorbidity index (HCT-CI) ≤5 * Adequate organ function defined as: 1. Cardiac: LVEF at rest ≥40% (RIC) or LVEF at rest ≥45% (MAC) 2. Pulmonary: DLCO, FEV1, FVC ≥50% predicted by pulmonary function tests (PFTs). DLCO value may be corrected for hemoglobin. 3. 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 4. 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) Exclusion Criteria: * Availability of suitable graft from living donor (defined as 7/8 or 8/8 HLA-matched related or unrelated donors, haploidentical donors, or cord blood donors) * Prior autologous or allogeneic HCT * Pregnancy or lactation * Ongoing treatment with an investigational drug used for disease-related treatment within 5 half-lives of the drug * Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings * Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute biphenotypic leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
City of Hope
Duarte, California, 91010, United States
-
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322, United States
-
Henry Ford Cancer Institute
Detroit, Michigan, 48202, United States
-
Methodist Hospital, Texas Transplant
San Antonio, Texas, 78229, United States
-
Moffitt Cancer Center
Tampa, Florida, 33612, United States
-
Oregon Health and Science University
Portland, Oregon, 97239, United States
-
St. David's South Austin Medical Center
Austin, Texas, 78745, United States
-
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203, United States
-
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Engineered immune cells aim to wipe out stubborn leukemia
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication
- Can a drug and donor cells stop leukemia from returning after transplant?