This study will evaluate combining stem cells from the patient's matched sibling donor (a standard CD34-selected transplant) with a second infusion of white blood cells called "CD8 memory T-cells" from their sibling donor.
Primary Objective: To determine the rate of graft versus host disease (GvHD) free, relapse free survival (GRFS) at one year following CD34 selected allogeneic hematopoietic cell transplantation using myeloablative conditioning combined with an infusion of phenotypic CD8+ memory T cells from human leukocyte antigen (HLA) matched donors for patients with myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), or acute lymphoblastic leukemia (ALL) and chronic myeloid leukemia (CML). Secondary Objective: To determine the rate of graft rejection, acute and chronic GvHD, non relapse mortality, relapse, overall survival, and disease free survival.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Allogeneic phenotypic CD8+ memory T cells from HLA matched donors infused at the time of hematopoietic cell transplantation
5 mg/kg/day: IV for 2 consecutive days (days -6 to -5)
25 mg/m2/day: IV for 5 consecutive days (days -6 to -2)
Stanford Medical Center
Stanford, California, United States
Number of Participants Achieving Graft-versus-Host Disease-Free and Relapse-Free Survival (GRFS) Through 1 Year Post-Transplant
The rate of participants who do not experience GvHD and also do not experience relapse are collectively considered to be GRFS. Relapse will be assessed according to the myelodysplastic syndrome or leukemia response criteria. The participants will be assessed for GRFS though 1 year post transplant. The outcome will be reported as the number of participants, a number without dispersion.
Time frame: 1 year
Number of Participants Experiencing Graft Rejection Through 1 Year Post-Transplant
Graft rejection will be determined on the basis of reaction against the donor hematopoietic cells. The outcome will be reported as the number of participants who experience graft rejection though 1 year post transplant, a number without dispersion
Time frame: 1 year
Number of Participants Experiencing Acute Graft-versus-Host Disease (GvHD) Through 1 Year Post-Transplant
The participants will be assessed for acute graft versus host disease (GvHD) though 1 year post transplant. The outcome will be reported as the number of participants who experience acute GvHD, a number without dispersion.
Time frame: 1 year
Number of Participants With Chronic, Steroid-Requiring Graft-versus-Host Disease (GvHD) Through 1 Year Post-Transplant
The participants will be assessed for chronic, steroid requiring graft versus host disease (GvHD) though 1 year post transplant. The outcome will be reported as the number of participants who experience chronic GvHD, a number without dispersion.
Time frame: 1 year
Number of Participants With Non-Relapse Mortality Through 1 Year Post-Transplant Without Recurrence of Myelodysplastic Syndrome or Leukemia
Non relapse mortality will be assessed as the number of participants who have died though 1 year post transplant, without a relapse or recurrence of their myelodysplastic syndrome or leukemia. Relapse will be assessed according to the myelodysplastic syndrome or leukemia response criteria. The outcome will be reported as the number of affected participants, a number without dispersion.
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Administered in 11 fractions of 125 cGy over 4 days (Total dose of 1375 cGy)
6 mg/kg/dose Q24h IV. Infused over 3 hours. 1 dose per day x 4 consecutive days x 3.6 mg/kg/dose = 14.4 mg/kg
60 mg/kg/dose Q24h IV. Infused over 2 hours. 1 dose per day x 2 consecutive days x 60 mg/kg/dose = 120 mg/kg
Time frame: 1 year
Number of Participants Who Experience Relapse Through 1 Year Post-Transplant
Relapse will be assessed according to the myelodysplastic syndrome or leukemia response criteria. The outcome will be reported as the number of participants who experience relapse though 1 year post transplant, a number without dispersion.
Time frame: 1 year
Overall Survival (OS)
Overall Survival (OS) will be assessed as the number of participants who remain alive at 1 year post transplant. The outcome will be reported as a number without dispersion.
Time frame: 1 year