Granulocyte Colony-stimulating Factor (G-CSF) Plus or Minus AMD3100 for Engraftment Post Allogeneic Transplant
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|ClinicalTrials.gov Identifier: NCT01026987|
Recruitment Status : Completed
First Posted : December 7, 2009
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Stem Cell Transplant Patients||Drug: G-CSF Drug: AMD3100 Procedure: Leukapheresis Procedure: Stem Cell Infusion||Phase 1|
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 (Clinical Trial)|
|Actual Enrollment :||29 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of G-CSF +/- Plerixafor (AMD3100) Mobilized Donor CD34+ Enriched Peripheral Blood Mononuclear Cells for the Treatment of Allogeneic Stem Cell Transplant Recipients With Limited Donor Engraftment|
|Actual Study Start Date :||April 29, 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||June 8, 2016|
Experimental: Related Donors: G-CSF & AMD3100
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.
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.
Other Name: NeupogenDrug: AMD3100
Other Names:Procedure: Leukapheresis
Stem Cell Infusion on Day 0
|Procedure: Stem Cell Infusion|
- Time to neutrophil engraftment [ Time Frame: 100 days post CD34+ selected, T-Cell depleted transplant ]
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 to platelet engraftment [ Time Frame: 100 days post CD34+ selected, T-Cell depleted transplant ]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 to red blood cell (RBC) improvement [ Time Frame: 100 days post CD34+ selected, T-Cell depleted transplant ]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.
- 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) [ Time Frame: 30 days post mobilization ]NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- 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) [ Time Frame: 1 year from date of transplant ]Overall survival is the time from the date of CD34+ selected, T-Cell depleted infusion to death.
- Incidence and severity of acute Graft vs Host Disease (GVHD) [ Time Frame: 100 days post-transplant ]Incidence and severity of acute GVHD will be assessed based on the Seattle criteria
- Toxicities associated with CD34+ cell infusion (recipients) [ Time Frame: 30 days post-transplant ]NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for all toxicity reporting.
- Disease-free survival [ Time Frame: 1 year from date of transplant ]Disease-Free survival is the time from the date of CD34+ selected, T-Cell depleted infusion to disease relapse or death.
- Incidence and severity of acute Graft vs Host Disease (GVHD) [ Time Frame: 2 years post-transplant ]Incidence and severity of chronic GVHD will be assessed based on the Seattle criteria
- Rate of transplant-related mortality (TRM) [ Time Frame: 100 days post-transplant ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01026987
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||John DiPersio, M.D., Ph.D.||Washington University School of Medicine|