Hematologic MalignancyNCT07710781
Study to Characterize Mismatched to Fully HLA-Matched Ossium HPC, Marrow and Living Donor Transplantation in Patients With Hematologic Malignancies
A study testing Ossium HPC, Marrow in people with Hematologic Malignancy and Acute Leukemia, run by Ossium Health, Inc..
Trial summary
Prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies. Read more about this study
- Who is it for?
- Ages 12 to 75 years
- Conditions the study is for
- Hematologic Malignancy, Acute Leukemia, Acute Lymphoblastic Leukemia
- What is being tested?
- Ossium HPC, Marrow
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 31 Mar 2031
- Phase
- Interventional
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 12 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient has the ability to provide informed consent according to the applicable regulatory and local institutional requirements.
- 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
- Patient must require first allogeneic HCT per the discretion of the treating physician
- BMI <=50 (BMI of 45.1 to 50 maybe allowed after sponsor approval)
- For treatment from Ossium product only- no suitable donor available after 3 weeks of search
- Patient must be high-resolution:
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- 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
- 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
- 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
- HLA haploidentical matched (4/8 allele matched at HLA-A, -B, -C, DRB1) to available PBSC donor for observational standard of care arm
- 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
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Patient with malignant hematologic disease including:
- 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
- MDS without Grade 3 fibrosis (Patients with Grade 1 and Grade 2 fibrosis can be enrolled with prior sponsor approval)
- Chronic Lymphocytic Leukemia (CLL) eligible for allogeneic transplant or
- Chronic Myeloid leukemia (CML) eligible for allogeneic transplant
- 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
- Other rare hematological malignancy indications eligible for allogenic transplant will require prior sponsor review and approval
- Absence of active CNS disease due to underlying hematological disease
- Karnofsky performance status score ≥70% (MAC) or ≥60% (RIC)
- HCT comorbidity index (HCT-CI) ≤5
- Adequate organ function defined as:
- 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 (dinakara correction) for hemoglobin.
- 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
- 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.
Who cannot join
- Autologous transplant within 6 months
- Prior allogeneic HCT
- Myeloproliferative disorders or MDS with grade 3 and higher fibrosis are excluded
- HTLV-ATLL positive patients are excluded
- Currently Pregnant or Currently lactating parent
- 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)
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- Recipient of allogeneic CART-T therapy
- Recipient of checkpoint inhibitor in last 3 months
- 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
- Presence of donor-specific antibodies. Recipient has positive anti-donor HLA antibodies against a mismatched HLA in the selected donor determined by either:
- positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing) or
- 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
- Patients with donor specific HLA antibodies (DSA) to donor that is reduced post treatment of de-sensitization for DSA
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicenter, Open Label Study to Evaluate the Efficacy, Tolerability, and Safety of Partially to Fully HLA-Matched Allogeneic Cryopreserved Deceased-Donor Bone Marrow Transplantation and Living Donor Transplantation in Patients With Hematologic Malignancies
Prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies.
Read the detailed description
This is a prospective, multi-center open label study of HLA-partially to fully matched allogeneic cryopreserved deceased donor bone marrow transplantation and living donor transplantation for patients with hematologic malignancies. The study will have block enrollment at each site (block size 3 patients). Patients will be enrolled in the following treatment arms for each block:
Experimental Arm:
Arm 1: Ossium HPC, marrow (n=100)
Observational arms:
Arm 2: Living mismatched unrelated PBSC donor (n=100) Arm 3: Living Haplo related PBSC donor (n=100)
The observational arm is standard of care arm. No prospective intervention will be specified, the data will be collected as per T\&E schedule. One hundred patients will be enrolled into each arm.
- Conditions
- Hematologic Malignancy, Acute Leukemia, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Acute Biphenotypic Leukemia, Acute Undifferentiated Leukemia
- Being tested
- Ossium HPC, Marrow, Standard of care living donor - Haplo Related, Standard of care living donor - Mismatched Unrelated
- Keywords
- Leukemia, Hematologic Diseases, ALL, AML, ABL, AUL, Bone Marrow Transplant, Stem cell Transplant, Lymphoma, MDS, CLL, CML
- Medical subject headings
- Hematologic Neoplasms, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Biphenotypic, Acute, Leukemia, B-Cell, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Anemia, Refractory, with Excess of Blasts, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ossium HPC, MarrowOther
Cryopreserved deceased donor bone marrow
Standard of care living donor - Haplo RelatedOther
Haplo Related PBSC donor
Standard of care living donor - Mismatched UnrelatedOther
Mismatched Unrelated PBSC donor
| Study group | Role | What they receive |
|---|---|---|
| Ossium HPC, Marrow Donor | Experimental | Not described Receives: Other: Ossium HPC, Marrow |
| Haplo Related PBSC Donor | Other | Standard of care living donor - Haplo Related PBSC Donor Receives: Other: Standard of care living donor - Haplo Related |
| Mismatched unrelated PBSC Donor | Other | Standard of care living donor - Mismatch Unrelated PBSC Donor Receives: Other: Standard of care living donor - Mismatched Unrelated |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine cumulative neutrophil engraftment
Characterize cumulative neutrophil engraftment in Ossium HPC, Marrow arm
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Mar 2029 (estimated)
- Study completion31 Mar 2031 (estimated)
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.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ossium Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07710781
- Sponsor's protocol ID
- PRESERVE II
- Other IDs
- 75A50124C00032
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No