Myeloablative Allogeneic Stem Cell Transplantation Using a Naive T-Cell Depleted Peripheral Blood Stem Cell Graft
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00814983|
Recruitment Status : Terminated (IND approval for naive T-cell depletion not obtained)
First Posted : December 29, 2008
Results First Posted : November 25, 2013
Last Update Posted : November 25, 2013
The primary objectives will be to measure the safety and efficacy of allogeneic stem cell transplantation using a peripheral blood stem cell graft that has been depleted of CD45RA+ Naive T-cells.
The secondary objectives will be to measure the pace of immune recovery.
|Condition or disease||Intervention/treatment||Phase|
|ALL ANLL MDS NHL||Procedure: Naive T-cell Depleted Stem Cell Transplant Procedure: Stem Cell Transplant No Manipulation Device: Isolex device from Baxter||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Myeloablative Allogeneic Stem Cell Transplantation Using a Naive T-Cell Depleted Peripheral Blood Stem Cell Graft|
|Study Start Date :||July 2007|
|Actual Primary Completion Date :||September 2013|
|Actual Study Completion Date :||September 2013|
Experimental: Naive T-cell Depleted Stem Cell Transplant
Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
Procedure: Naive T-cell Depleted Stem Cell Transplant
The Isolex device from Baxter will be used to perform the cell selection procedure. After the CD34 selected stem cell graft has been collected, the CD34- "flow-through"fraction will be depleted of CD45RA+ naive T-cells. To accomplish this, a second immunomagnetic bead selection process will be performed on the Isolex device, making use of a GMP-grade murine anti-human CE45RA antibody. This depleted fraction will comprise the donor lymphocyte inoculum given to the transplant recipient along with the stem cell component on day 0 of transplant.
Device: Isolex device from Baxter
Active Comparator: Stem Cell Transplant No Manipulation
Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
Procedure: Stem Cell Transplant No Manipulation
These patients will be transplanted with unmanipulated peripheral blood stem cells.
- The Incidence of Grade II-IV Acute Graft Versus Host Disease [ Time Frame: One year from date of transplant ]
- Disease Free Survival [ Time Frame: One year ]
- Rate of Immune Recovery [ Time Frame: 3 years ]The time to recovery of T-cell subset, B cell and NK cell recovery will be monitored along with T-Cell proliferative response to mitogens.
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): NCT00814983
|Principal Investigator:||Mitchell Horwitz, MD||Duke University Health System|