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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Related Donors: G-CSF & AMD3100 | Experimental | G-CSF 10 ug/kg SC daily for 5 days. AMD3100 320 mcg/kg IV over 30 min on Day 5. Leukapheresis on Day 5. |
|
| Recipient | Other | Stem Cell Infusion on Day 0 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| G-CSF | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 100 days post CD34+ selected, T-Cell depleted transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 (transplant day) | |
| Toxicities associated with the CD34+ collection (donors) |
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Inclusion Criteria:
Recipient
Unrelated Donors
Related donors
Exclusion Criteria:
Recipient
Donor
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| Name | Affiliation | Role |
|---|---|---|
| John DiPersio, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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| ID | Term |
|---|---|
| D016179 | Granulocyte Colony-Stimulating Factor |
| D000069585 | Filgrastim |
| C088327 | plerixafor |
| D007937 | Leukapheresis |
| ID | Term |
|---|---|
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
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|
| AMD3100 | Drug |
|
|
| Leukapheresis | Procedure |
|
| Stem Cell Infusion | Procedure |
|
NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
| 30 days post mobilization |
| 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. | 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. | 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 | 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. | 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. | 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 | 2 years post-transplant |
| Rate of transplant-related mortality (TRM) | 100 days post-transplant |
| D016298 |
| Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D016238 | Cytapheresis |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D001781 | Blood Component Removal |
| D047589 | Leukocyte Reduction Procedures |
| D002469 | Cell Separation |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D008919 | Investigative Techniques |