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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Hematopoetic Cell Transplantation
Regimen A or Regimen B
Regimen C or Regimen D
Post-transplant treatment
City of Hope
Duarte, California, United States
RECRUITINGMoffitt Cancer Center
Tampa, Florida, United States
RECRUITINGEmory University - Winship Cancer Institute
Atlanta, Georgia, United States
RECRUITINGHenry Ford Cancer Institute
Detroit, Michigan, United States
RECRUITINGOregon Health and Science University
Portland, Oregon, United States
RECRUITINGTriStar Bone Marrow Transplant
Nashville, Tennessee, United States
RECRUITINGSt. David's South Austin Medical Center
Austin, Texas, United States
RECRUITINGMethodist Hospital, Texas Transplant
San Antonio, Texas, United States
RECRUITINGUniversity of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States
RECRUITINGNeutrophil 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
Cumulative incidences of neutrophil engraftment
Neutrophil engraftment in defined as achieving an absolute neutrophil count (ANC) of greater than or equal to 500/µL for 3 consecutive measurements on different days by Day 28.
Time frame: Day 28
Cumulative incidences of platelet recovery
Platelet recovery is defined as platelets greater than or equal to 20,000/µL for 3 consecutive days in the absence of transfusion for 7 consecutive days by Day 56.
Time frame: Day 56
Cumulative incidence of disease relapses
The cumulative incidence of relapse is measured from the date of transplant (Day 0) until the date of relapse or progression; patients not known to have relapsed are censored on the date they were last examined; patients who died without relapse are counted as a competing cause of failure.
Time frame: Day 365
Transplant-related mortality (TRM)
TRM is defined as death without evidence of disease progression or recurrence.
Time frame: Day 100 and Day 365
Cumulative incidences of acute (aGVHD) Graft Versus Host Disease
aGVHD is defined as any skin, gastrointestinal or liver abnormalities fulfilling the criteria of grades II-IV or grades III-IV.
Time frame: Day 100, Day 180, and Day 365
Cumulative incidences of chronic (cGVHD) Graft Versus Host Disease
cGVHD is defined per National Institutes of Health (NIH) Consensus Criteria and includes organ involvement and severity, and overall global composite score (mild/moderate/severe).
Time frame: Day 100, Day 180, and Day 365
Incidence of clinically-significant infections
A clinically significant infection is defined as any microbiologic or radiographic infection for which antimicrobial therapy was administered.
Time frame: Day 100 and Day 365
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