Patients who have not had adequate blood count recovery post related or unrelated stem cell transplant will be given a "boost" of T-cell depleted, enriched stem cells to hopefully improve their blood counts.
Patients who have not had adequate blood count recovery post related or unrelated stem cell transplant will be given a "boost" of T-cell depleted, enriched stem cells to hopefully improve their blood counts. The unrelated donors will receive G-CSF prior to pheresis (collection of the stem cells) to boost the number of CD34+ cells. The related donors will receive G-CSF and AMD3100 prior to pheresis to boost the number of CD34+ cells. Once the CD34+ cells are collected they will be T-cell depleted using a cell separation device called the CliniMACS systems. The CliniMACS system will select the CD34+ cell and remove the T-cells. By removing the T-cells we can minimize the risk of Graft Versus Host Disease (GVHD). The enriched CD34+ cells will be given to them to hopefully give them a "boost" of cells that can permanently produce new blood cells to improve their risk of infection and bleeding.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
29
Unrelated donors will receive only G-CSF (10 ug/Kg S/C qDay x5-6 days) prior to pheresis (collection of the stem cells). Unrelated donors will only be followed per NMDP guidelines.
Washington University School of Medicine
St Louis, Missouri, United States
Time to neutrophil engraftment
For recipients with ANC \< 500 or growth factor support dependent at study entry, Time to neutrophil improvement is measured from the date of CD34+ selected, T-Cell depleted infusion to the first of 3 consecutive measurements of neutrophil count \> 500/μl without growth factor support for \>7 days prior. RBC transfusion engraftment - independence from RBCs without growth factors.
Time frame: 100 days post CD34+ selected, T-Cell depleted transplant
Time to platelet engraftment
For recipients with platelets \< 20,000 or platelet transfusion dependent at study entry, Time to platelet improvement is measured from the date of CD34+ selected, T-Cell depleted infusion to the of 3 consecutive measurements of platelet count ≥ 20,000/ul without platelet transfusion support for 7 days.
Time frame: 100 days post CD34+ selected, T-Cell depleted transplant
Time to red blood cell (RBC) improvement
For recipients who are RBC transfusion dependent at study entry, Time to RBC improvement is measured from the date of CD34+ selected, T-Cell depleted infusion to the first date of hemoglobin \>9.0g/dL without \> 1 RBC transfusion during the previous 56 days.
Time frame: 100 days post CD34+ selected, T-Cell depleted transplant
To assess the feasibility of collecting adequate donor CD34+ enriched T-cell depleted peripheral blood stem cells using G-CSF+ plerixafor from related donors and G-CSF alone from unrelated donors.
Time frame: Day 0 (transplant day)
Toxicities associated with the CD34+ collection (donors)
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time frame: 30 days post mobilization
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Phenotypically and functionally characterize donor CD34+ and donor T-cells mobilized by G-CSF from unrelated donors and mobilized with G-CSF + plerixafor from related donors.
Time frame: Day of mobilization (Day 0)
Overall survival (recipients)
Overall survival is the time from the date of CD34+ selected, T-Cell depleted infusion to death.
Time frame: 1 year from date of transplant
Incidence and severity of acute Graft vs Host Disease (GVHD)
Incidence and severity of acute GVHD will be assessed based on the Seattle criteria
Time frame: 100 days post-transplant
Toxicities associated with CD34+ cell infusion (recipients)
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
Time frame: 30 days post-transplant
Disease-free survival
Disease-Free survival is the time from the date of CD34+ selected, T-Cell depleted infusion to disease relapse or death.
Time frame: 1 year from date of transplant
Incidence and severity of acute Graft vs Host Disease (GVHD)
Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria
Time frame: 2 years post-transplant
Rate of transplant-related mortality (TRM)
Time frame: 100 days post-transplant