Reduced intensity conditioning (RIC) has emerged and been increasingly adopted as a modality to allow preparative conditioning pre transplant to be tolerated by older adults or those patients that are otherwise unfit for myeloablative conditioning. In this study, we aim to use RIC followed by matched related/unrelated donor, 7/8 matched related/unrelated donor, or haploidentical donor peripheral blood stem cell transplantation. Standard strategies to control the alloreactivity following HCT utilize immunosuppressive or cytotoxic medications. In this study, we explore donor graft engineering to enrich for immmunoregulatory populations to facilitate post transplantation immune reconstitution while minimizing graft versus host disease (GVHD) with post-transplant immunosuppressive agents.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. For Arm A1 (CLOSED):
✓. For Arm A1 and Arm A3:
✓. For Arm B (CLOSED):
✓. For Arm C1 (CLOSED) and C2:
✓. Age ≥ 18 and ≤ 75 years of age
✓. Karnofsky performance status of ≥ 70% defined by institutional standards
✓. Seronegative for HIV-1 RNA PCR; HIV 1 and HIV 2 ab (antibody); HTLV-1 and HTLV-2 ab; PCR+ or sAg (surface antigen) hepatitis B ; or PCR or sAg negative for hepatitis C; negative for the Treponema palladum antibody Syphillis screen; and negative for HIV-1 and hepatitis C by nucleic acid testing (NAT) within 30 days of apheresis collection.
✓. In the case that T palladum antibody tests are positive, donors must:
Exclusion criteria
✕. Seropositive for any of the following:
✕. Patients deemed candidates for fully myeloablative preparative conditioning regimens
What they're measuring
1
Determine the GVHD-free relapse-free survival (GRFS) post-HCT ( Arm-A)
Timeframe: 12 months
2
Determine the overall survival (OS) post-HCT ( Arm-B)
Timeframe: 2 years
3
Incidence of Grade III-IV acute GVHD
Timeframe: At baseline, day +30, 60, 90, 180, year 1 and year 2
4
The incidence and timing of primary graft failure
Timeframe: 2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion
5
Donor CD3 chimerism at Day+60 post-HCT
Timeframe: 2 years from the Day 0 (day of CD34+ peripheral blood stem cell infusion)