A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
NCT ID: NCT05589896
Last Updated: 2025-06-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1/PHASE2
12 participants
INTERVENTIONAL
2024-08-16
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bone Marrow Transplantation With Specially Treated Bone Marrow in Treating Patients With Hematologic Cancer That Have Not Responded to Previous Therapy
NCT00005988
Bone Marrow Transplantation in Treating Patients With Severe Aplastic Anemia or Rejection of Previous Bone Marrow Transplant
NCT00005852
Low-Dose Total Body Irradiation and Donor Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Patients With Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, or Multiple Myeloma
NCT00003196
Non-Myeloablative HLA-Mismatched Ex-Vivo T-cell Depleted Stem Cell Transplantation for Hematologic Malignancies
NCT00113646
NMA Allogeneic Hematopoietic Cell Transplant in Hematologic Cancer/Disorders
NCT00053989
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort 1
Bone Marrow Transplant with Ossium HPC, Marrow
Pre-transplant myeloablative conditioning treatment with:
Regimen A(MAC): Busulfan and Fludarabine
\[OR\]
Regimen B(MAC): Fludarabine and Total Body Irradiation
\[OR\]
Regimen C(RIC): Fludarabine, Cyclophosphamide, and Total Body Irradiation
\[OR\]
Regimen D (RIC): Fludarabine, Melphalan, and Total Body Irradiation
Post-Transplant treatment with Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, and Filgrastim
Ossium HPC Marrow, Bone Marrow Transplant
Hematopoetic Cell Transplantation
Pre-transplant conditioning - Myeloablative (MAC)
Regimen A or Regimen B
Pre-transplant conditioning - Reduced Intensity (RIC)
Regimen C or Regimen D
Post-transplant treatment
Post-transplant treatment
Cohort 2
\*Open to enrollment after DSMB review of Cohort 1 safety events through Day 56\*
Bone Marrow Transplant with Ossium HPC, Marrow
Pre-transplant conditioning treatment with:
Regimen A(MAC): Busulfan and Fludarabine
\[OR\]
Regimen B(MAC): Fludarabine and Total Body Irradiation
\[OR\]
Regimen C(RIC): Fludarabine, Cyclophosphamide, and Total Body Irradiation
\[OR\]
Regimen D(RIC): Fludarabine, Melphalan, and Total Body Irradiation
Post-Transplant treatment with Cyclophosphamide, Tacrolimus, Mycophenolate Mofetil, and Filgrastim
Ossium HPC Marrow, Bone Marrow Transplant
Hematopoetic Cell Transplantation
Pre-transplant conditioning - Myeloablative (MAC)
Regimen A or Regimen B
Pre-transplant conditioning - Reduced Intensity (RIC)
Regimen C or Regimen D
Post-transplant treatment
Post-transplant treatment
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ossium HPC Marrow, Bone Marrow Transplant
Hematopoetic Cell Transplantation
Pre-transplant conditioning - Myeloablative (MAC)
Regimen A or Regimen B
Pre-transplant conditioning - Reduced Intensity (RIC)
Regimen C or Regimen D
Post-transplant treatment
Post-transplant treatment
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Center for International Blood and Marrow Transplant Research
NETWORK
Ossium Health, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffery Auletta, MD
Role: STUDY_CHAIR
Center for International Blood and Marrow Transplant Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
City of Hope
Duarte, California, United States
Moffitt Cancer Center
Tampa, Florida, United States
Henry Ford Cancer Institute
Detroit, Michigan, United States
Columbia University - Herbert Irving Comprehensive Cancer Center
New York, New York, United States
Oregon Health and Science University
Portland, Oregon, United States
TriStar Bone Marrow Transplant
Nashville, Tennessee, United States
St. David's South Austin Medical Center
Austin, Texas, United States
Methodist Hospital, Texas Transplant
San Antonio, Texas, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Miranda Garcia
Role: primary
Eric Hornfeck
Role: primary
Abhinav Krishnaswami
Role: primary
Elizabeth Shelton, MPH
Role: primary
Elisa Minerich
Role: primary
Sydney Fitzgerald
Role: primary
Stephanie Goldin
Role: primary
Tatiana Aguirre Robles Gil, MD
Role: primary
Mia Kowalczyk
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PRESERVE I
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.