Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00038818
Status:
TERMINATED
Last Update Posted:
2012-08-23
First Post:
2002-06-05
Brief Title:
CD8 DLI for Patients With Relapse or Residual Disease Following Allogeneic Stem Cell Transplantation
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
CD8 Depleted Donor Lymphocyte Infusions for Patients With Relapse Or Residual Disease Following Allogeneic Stem Cell Transplantation
Status:
TERMINATED
Status Verified Date:
2012-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Low accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
To evaluate response rates of acute or chronic Graft-versus-host disease GVHD following CD8 depleted DLI Depleted Donor Lymphocyte Infusions in patients with Chronic myelomonocytic leukemia CMML chronic lymphoid leukemia CLL Non-Hodgkins lymphoma NLM Multiple Myeloma MM and Hodgkins Lymphoma HD
Secondary Objectives
To evaluate safety and treatment related mortality after CD8 depleted DLI
To evaluate the time to onset of GVHD following DLI and response to GVHD treatment
To evaluate the incidence and timing of pancytopenia following DLI
To evaluate disease-free survival overall survival and relapse rates in three cohorts of patients early relapse CML late relapse CML and lymphoproliferative disorders HD CLL NHL and MM
To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions
To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4 cells
To evaluate response rates of acute or chronic Graft-versus-host disease GVHD following CD8 depleted DLI Depleted Donor Lymphocyte Infusions in patients with Chronic myelomonocytic leukemia CMML chronic lymphoid leukemia CLL Non-Hodgkins lymphoma NLM Multiple Myeloma MM and Hodgkins Lymphoma HD
Secondary Objectives
To evaluate safety and treatment related mortality after CD8 depleted DLI
To evaluate the time to onset of GVHD following DLI and response to GVHD treatment
To evaluate the incidence and timing of pancytopenia following DLI
To evaluate disease-free survival overall survival and relapse rates in three cohorts of patients early relapse CML late relapse CML and lymphoproliferative disorders HD CLL NHL and MM
To evaluate the need and efficacy of second or subsequent CD8 depleted donor lymphocyte infusions
To evaluate the number of apheresis procedures needed to collect appropriate doses of CD4 cells
Detailed Description:
None
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