Ignite Creation Date:
2024-05-06 @ 7:40 AM
Last Modification Date:
2024-10-26 @ 11:50 AM
Study NCT ID:
NCT02570542
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2015-10-05
Brief Title:
Study of the Impact of CD34 Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma DLBCL
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
A Multi-center Randomized Phase II Study of the Impact of CD34 Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma DLBCL
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to study the impact of stem cell dose on outcome after autologous transplant
Detailed Description:
Following enrollment patients will be CD34 stem cell mobilized at the discretion of the treating attending physician with the plerixafor for the achievement of 6 x106 CD34 cellskg The patients that fail to mobilize 6 x106 CD34 cellskg will not be randomized and will subsequently be followed for disease progression and overall survival Patients with 6 x106 CD34 cellskg cryopreserved on study will be admitted to the hospital for planned ASCT Patients will be randomly infused with either 3-4 x 106 CD34 stem cellskg or 6-8 x106 CD34 stem cellskg on d0 per study randomization The cell dose ranges within the two groups allows variability within aliquots of cells at the time of cryopreservation Patients will receive standard supportive measures including growth factor support post-HDTASCT antimicrobial prophylaxis red blood cell and platelet transfusion and treatment for neutropenic fever as per institutional guideline practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None