A First-in-Human Study of HLA-Partially to Fully Matched Allogenic Cryopreserved Deceased Donor Bone Marrow Transplantation for Patients With Hematologic Malignancies
Summary
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.
Arms & interventions
- OtherOssium HPC Marrow, Bone Marrow Transplant
Hematopoetic Cell Transplantation
- OtherPre-transplant conditioning - Myeloablative (MAC)
Regimen A or Regimen B
- OtherPre-transplant conditioning - Reduced Intensity (RIC)
Regimen C or Regimen D
- OtherPost-transplant treatment
Post-transplant treatment
Outcome measures
Primary
Neutrophil Engraftment
Neutrophil engraftment is defined as achieving an absolute neutrophil count (ANC) of greater than or equal to 500/µL for 3 consecutive measurements on 3 different days by Day 28.
Time frame: Day 28
Serious Adverse Events
Occurrence of any event classified as SAE. The time of occurrence of each serious adverse event will be recorded.
Time frame: Day 56
CTCAE Grade 3/4 Adverse Events (AEs)
Occurrence of any event classified as grade 3/4 AE attributed to Ossium HPC, Marrow per the CTCAE v5.0 guidelines. The time of the occurrence of each event will be recorded.
Time frame: Day 56
CTCAE Grade 3/4 Adverse Events (AEs) attributed to infusion of Ossium HPC, Marrow
Occurrence of any event classified as grade 3 or higher attributed to Ossium HPC, Marrow infusion per the CTCAE v5.0 guidelines. The time of the occurrence will be recorded.
Time frame: Day 28
Death
The time of death will be recorded for each expired patient.
Time frame: Day 56
Secondary
Cumulative incidences of neutrophil engraftment
Time frame: Day 28
Cumulative incidences of platelet recovery
Time frame: Day 56
Cumulative incidence of disease relapses
Time frame: Day 365
Transplant-related mortality (TRM)
Time frame: Day 100 and Day 365
Cumulative incidences of acute (aGVHD) Graft Versus Host Disease
Time frame: Day 100, Day 180, and Day 365
Cumulative incidences of chronic (cGVHD) Graft Versus Host Disease
Time frame: Day 100, Day 180, and Day 365
Incidence of clinically-significant infections
Time frame: Day 100 and Day 365
Eligibility criteria
Study locations (9)
City of Hope
Duarte, California, 91010
Moffitt Cancer Center
Tampa, Florida, 33612
Emory University - Winship Cancer Institute
Atlanta, Georgia, 30322
Henry Ford Cancer Institute
Detroit, Michigan, 48202
Oregon Health and Science University
Portland, Oregon, 97239
TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
St. David's South Austin Medical Center
Austin, Texas, 78745
Methodist Hospital, Texas Transplant
San Antonio, Texas, 78229
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, 84112