This pilot study is being conducted to treat patients who have a certain type of malignancy (lymphoid or myeloid) with immune effector cells after a T-cell depleted allogeneic hematopoietic cell transplantation (TCD HSCT). This study is designed to see whether an investigational cellular product of immune cells obtained from a donor's cells that have been treated so that the type of cells that can lead to graft vs host disease have been removed can be safely administered. These cell products are administered following the initial stem cell transplant to assess the effect and improvement on minimal residual disease status, infectious complication, progression-free and overall survival.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
T-cell Receptor α/β Depleted Donor Lymphocyte Infusions following CD34+-selected Allogeneic Stem Cell Transplantation from Related and Unrelated Donors for Patients
Miami Cancer Institute at Baptist Health, Inc
Miami, Florida, United States
Incidence of Treatment-emergent Serious Adverse Events (TE-SAEs)
TE-SAEs are defined as the composite of death, non-fatal pulmonary embolism, stroke, acute graft versus host disease (GvHD), and clinically significant laboratory test abnormalities.
Time frame: 30 days post-infusion
Number of Participants in Remission
Remission - measured by absence of signs and symptoms
Time frame: 2 years
Number of Participants With Transplant-associated Viral Complications
Transplant-associated viral complications - measured by viral infections associated with transplant
Time frame: 2 years
Disease Free Survival- Measured by Absence of Relapse/Recurrence or Death.
Disease free survival - measured by (absence of ) relapse/recurrence or death. Relapse and recurrence, both will be measured by greater than 5% circulating leukemic blasts in the marrow or peripheral blood and/or the presence of blasts in any extra medullary site and/or disease determined by clinical assessment.
Time frame: 2 years
Overall Survival
Overall survival - measured by death
Time frame: 2 years
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