A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
Ossium Health, Inc.
Study ID
NCT05589896
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Acute Biphenotypic Leukemia
  • Acute Leukemia
  • Acute Lymphoblastic Leukemia
  • Acute Myeloid Leukemia
  • Acute Undifferentiated Leukemia
  • CLL (Chronic Lymphocytic Leukemia)
  • Chronic Myeloid Leukemia (CML)
  • Cutaneous T Cell Lymphomas (CTCL)
  • Hodgkins Lymphoma
  • MDS (Myelodysplastic Syndrome)
  • Non-Hodgkin Lymphomas

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ossium HPC Marrow, Bone Marrow Transplant — OTHER
    Hematopoetic Cell Transplantation
  • Pre-transplant conditioning - Myeloablative (MAC) — OTHER
    Regimen A or Regimen B
  • Pre-transplant conditioning - Reduced Intensity (RIC) — OTHER
    Regimen C or Regimen D
  • Post-transplant treatment — OTHER
    Post-transplant treatment

Study Details

The goal of this clinical trial is to determine the safety and feasibility of allogeneic transplantation with bone marrow from a deceased donor in patients with acute and chronic leukemias, myelodysplastic syndrome, and certain lymphomas. Patients will either receive myeloablative conditioning or reduced intensity conditioning regimen prior to the transplant. Patients will be followed for 56 days for safety endpoints and remain in follow-up for one year.

Key Dates

Start date
Aug 16, 2024
Status verified
Jun 2025
Primary completion
May 31, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: 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
  • Experimental: 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

Primary Outcome Measure

Neutrophil Engraftment [ Time Frame: Day 28 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Sunmin Park, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Taiga Nishihori, MD (PRINCIPAL_INVESTIGATOR)
Emory University - Winship Cancer InstituteAtlantaGeorgia30322
Colin Vale, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Cancer InstituteDetroitMichigan48202
Muneer Abidi, MD (PRINCIPAL_INVESTIGATOR)
Oregon Health and Science UniversityPortlandOregon97239
Arpita Gandhi, MD (PRINCIPAL_INVESTIGATOR)
TriStar Bone Marrow TransplantNashvilleTennessee37203
Jeremy Pantin, MD (PRINCIPAL_INVESTIGATOR)
St. David's South Austin Medical CenterAustinTexas78745
Uttam Rao, MD (PRINCIPAL_INVESTIGATOR)
Methodist Hospital, Texas TransplantSan AntonioTexas78229
Nosha Farhadfar, MD (PRINCIPAL_INVESTIGATOR)
University of Utah - Huntsman Cancer InstituteSalt Lake CityUtah84112
Sagar Patel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
City of Hope· Duarte, CAMoffitt Cancer Center· Tampa, FLEmory University - Winship Cancer Institute· Atlanta, GAHenry Ford Cancer Institute· Detroit, MIOregon Health and Science University· Portland, ORTriStar Bone Marrow Transplant· Nashville, TN

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