Study to Characterize Mismatched to Fully HLA-Matched Ossium HPC, Marrow and Living Donor Transplantation in Patients With Hematologic Malignancies

NCT07710781 | Not Yet Recruiting

• 1 other identifier: PRESERVE II
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hematologic Malignancy; Non Hodgkin Lymphoma; Hodgkin Lymphoma; Acute Leukemia; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Acute Biphenotypic Leukemia; Acute Undifferentiated Leukemia; CLL (Chronic Lymphocytic Leukemia); Chronic Myeloid Leukemia; MDS (Myelodysplastic Syndrome); Cutaneous T Cell Lymphomas (CTCL)

Keywords

Leukemia; Hematologic Diseases; ALL; AML; ABL; AUL; Bone Marrow Transplant; Stem cell Transplant; Lymphoma; MDS; CLL; CML

Outcome Measures

Primary Outcomes (1)

• To determine cumulative neutrophil engraftment

  Characterize cumulative neutrophil engraftment in Ossium HPC, Marrow arm

  Day 30

Study Arms (3)

Ossium HPC, Marrow Donor

EXPERIMENTAL

Other: Ossium HPC, Marrow

Haplo Related PBSC Donor

OTHER

Standard of care living donor - Haplo Related PBSC Donor

Other: Standard of care living donor - Haplo Related

Mismatched unrelated PBSC Donor

OTHER

Standard of care living donor - Mismatch Unrelated PBSC Donor

Other: Standard of care living donor - Mismatched Unrelated

Interventions

Ossium HPC, Marrow OTHER

Cryopreserved deceased donor bone marrow

Ossium HPC, Marrow Donor

Standard of care living donor - Haplo Related OTHER

Haplo Related PBSC donor

Haplo Related PBSC Donor

Standard of care living donor - Mismatched Unrelated OTHER

Mismatched Unrelated PBSC donor

Mismatched unrelated PBSC Donor

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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)

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Ossium Health, Inc.: lead

MeSH Terms

Conditions

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; Hodgkin Disease; Lymphoma, T-Cell, Cutaneous; Leukemia; Hematologic Diseases; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid; Myeloproliferative Disorders; Bone Marrow Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Anemia, Refractory; Anemia; Myelodysplastic Syndromes; Lymphoma, T-Cell

Central Study Contacts

Preethi Prasad

CONTACT

628-842-6562; preethi.prasad@ossiumhealth.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 17, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): March 31, 2029
• Study Completion (Estimated): March 31, 2031
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share