Could bone marrow from deceased donors cure blood cancers?

NCT ID NCT07710781

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 17, 2026 · Last updated Jul 21, 2026 · Updated 2 times

Summary

This study tests whether bone marrow from deceased donors can be used to treat people with blood cancers like leukemia and lymphoma. Participants receive a transplant of cryopreserved marrow from a deceased donor or standard cells from a living donor. The goal is to see if the deceased-donor marrow can successfully restore healthy blood cell production.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cryopreserved bone marrow from deceased donors
What this could lead to
If successful, this could make bone marrow transplants available to more patients by using deceased donors, reducing wait times and expanding the donor pool.
What could go wrong
This is an early-stage study, and it is unknown if deceased-donor marrow will engraft as reliably as living-donor cells. Risks include graft failure, infection, and graft-versus-host disease.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

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

12 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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements. 2. Male or female, aged ≥12 and ≤65 years for patients receiving MAC aged ≥12 and ≤75 years for patients receiving RIC. Patients between 75 and 80 years on RIC regimen can be enrolled with prior sponsor approval 3. Patient must require first allogeneic HCT per the discretion of the treating physician 4. BMI \<=50 (BMI of 45.1 to 50 maybe allowed after sponsor approval) 5. For treatment from Ossium product only- no suitable donor available after 3 weeks of search 6. Patient must be high-resolution: 1. HLA partially or fully matched (4-8/8 allele matched at HLA-A, -B, -C, DRB1) to an available Ossium HPC, Marrow product for experimental arm 2. HLA fully matched (8/8 allele matched at HLA-A, -B, -C, DRB1) to an unrelated available PBSC donor for observational standard of care arm 3. HLA partially matched (4-7/8 allele matched at HLA-A, -B, -C, DRB1) to an available PBSC donor for observational standard of care arm 4. HLA haploidentical matched (4/8 allele matched at HLA-A, -B, -C, DRB1) to available PBSC donor for observational standard of care arm 5. HLA partially matched (4-8/8 allele matched at HLA-A, -B, -C, DRB1) to an available living bone marrow donor for optional observational standard of care arm 7. Stated willingness to comply with all study procedures and availability for the duration of the study 8. Patient with malignant hematologic disease including: 1. Diagnosed with acute leukemia \[acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), acute biophenotypic leukemia (ABL), or acute undifferentiated leukemia (AUL)\], , in the first remission or beyond with ≤5% marrow blasts and no circulating blasts or extra-medullary disease documented by bone marrow assessment within 42 days prior to anticipated start of conditioning or 2. MDS without Grade 3 fibrosis (Patients with Grade 1 and Grade 2 fibrosis can be enrolled with prior sponsor approval) 3. Chronic Lymphocytic Leukemia (CLL) eligible for allogeneic transplant or 4. Chronic Myeloid leukemia (CML) eligible for allogeneic transplant 5. Chemosensitive 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 6. Other rare hematological malignancy indications eligible for allogenic transplant will require prior sponsor review and approval 7. Absence of active CNS disease due to underlying hematological disease 9. Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC) 10. HCT comorbidity index (HCT-CI) ≤5 11. 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 (dinakara correction) for hemoglobin. 3. Hepatic: total bilirubin ≤2.0 mg/dL (except Gilbert syndrome ), and ALT, AST, and ALP \<3 x upper limit normal (ULN), unless ALT, AST, and/or ALP are disease related 4. Renal: CrCl\> 45 mL/min/1.73m2 must be obtained (measured by 24-hour urine specimen or nuclear glomerular filtration rate (GFR), or calculated GFR (by Cockcroft-Gault formula)) or Cystatin-C test. Exclusion Criteria: 1. Autologous transplant within 6 months 2. Prior allogeneic HCT 3. Myeloproliferative disorders or MDS with grade 3 and higher fibrosis are excluded 4. HTLV-ATLL positive patients are excluded 5. Currently Pregnant or Currently lactating parent 6. Participation with an investigational trial within 3 months of planned transplant (Note: participation in survey studies or standard of care studies maybe allowed after sponsors approval or are part of long term follow up for an interventional trial) 7. Recipient of allogeneic CART-T therapy 8. Recipient of checkpoint inhibitor in last 3 months 9. Current uncontrolled bacterial, viral or fungal infection defined as currently taking medication with evidence of progression of clinical symptoms or radiologic findings 10. Any condition(s) or diagnosis, both physical or psychological, or physical exam finding that in the investigator's opinion precludes participation 11. Presence of donor-specific antibodies. Recipient has positive anti-donor HLA antibodies against a mismatched HLA in the selected donor determined by either: 1. positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing) or 2. presence of donor specific HLA antibodies (DSA) to any mismatched HAS allele/antigen at any of the following loci (HLA-A, -B, -C, -DRB1, -DPA1, -DPB1) with median fluoresce intensity (MFI) \>3000 by Luminex single antigen bead based solid phase immunoassay tested prior to SSA request and repeated if transplant is \>30 days from prior HLA antibody testing or if patient receives additional blood products/transfusion prior to transplant 3. Patients with donor specific HLA antibodies (DSA) to donor that is reduced post treatment of de-sensitization for DSA

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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