T-cell Receptor α/β Depleted Donor Lymphocyte Infusion
Lymphoid Leukemia, Acute, Myeloid Malignancy, Plasma Cell Tumor
About this trial
This is an interventional treatment trial for Lymphoid Leukemia, Acute
Eligibility Criteria
Inclusion Criteria:
Patients with hematologic malignancies that are candidates CD34+ selected, T-cell depleted allogeneic hematopoietic stem cell transplantation
- Patient's age includes >18 to < 75 years old.
- Patients may be of either gender or any ethnic background.
- Patients must have a Karnofsky (adult) Performance Status of at least 70%.
- Patients must have adequate organ function measured by:
Cardiac: asymptomatic or if symptomatic then LVEF at rest must be 50% and must improve with exercise.
Hepatic: < 3x ULN AST and: s 1.5 total serum bilirubin, unless there is congenital benign hyperbilirubinemia. Patients with higher bilirubin levels due to causes other than active liver disease is also eligible with Pl approval e.g. patients with PNH, Gilbert's disease or other hemolytic disorders.
Renal: serum creatinine: s; 1.2 mg/dl or if serum creatinine is outside the normal range, then CrCl > 40 ml/m in (measured or calculated/estimated).
Pulmonary: asymptomatic or if symptomatic, DLCO 50% of predicted (corrected for hemoglobin).
Each patient must be willing to participate as a research subject and must sign an informed consent form.
Exclusion Criteria:
- • Patients with active acute GvHD
Sites / Locations
- Miami Cancer Institute at Baptist Health, Inc
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
HLA Matched Cohort I
HLA Matched Cohort II
HLA Matched Cohort III
HLA Mismatched Cohort I
HLA Mismatched Cohort II
HLA Mismatched Cohort III
5 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)
5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose
5 x 10^5/kg starting time point X (whichever was safest as determined by Matched Cohort I), 1 x 10^6/kg 3-4 weeks after first dose, and 2 x 10^6/kg 3-4 weeks after second dose
1 x 10^5/kg at 6-7 weeks post-transplant (Group A), 4-5 weeks post-transplant (Group B), or 2-3 weeks post-transplant (Group C)
1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 5 x 10^5/kg 3-4 weeks after second dose
1 x 10^5/kg starting time point Y (whichever was safest as determined by Mismatched Cohort I), 5 x 10^5/kg 3-4 weeks after first dose, and 1 x 10^6/kg 3-4 weeks after second dose