Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation
This trial is active, not recruiting.
|Conditions||multiple myeloma, blood and marrow transplant (bmt)|
|Treatment||cytokine induced killer cells|
|Collaborator||National Institutes of Health (NIH)|
|Start date||June 2004|
|End date||December 2012|
|Trial size||20 participants|
|Trial identifier||NCT00185757, 13644, 95070, BMT162|
The purpose of the study is to determine if the use of activated T cells can effectively treat relapsed disease following allogeneic hematopoietic cell transplantation without causing GVHD.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system.
time frame: 21 to 28days before infusion
To determine the infusional toxicity of ex vivo expanded allogeneic CIK cells in patients with recurrent or refractory disease following allogeneic hematopoietic cell transplantation.
time frame: day of infusion up to 24 hours after infusion
To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells.
time frame: first 100 days after infusion
To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion.
time frame: day plus 100 after infusion
o determine the incidence of disease response following treatment with allogeneic CIK cells.
time frame: one year
To assess donor-specific chimerism before and after treatment with allogeneic CIK cells.
time frame: 3 months
To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system.
time frame: 21-28 days
Male or female participants from 18 years up to 75 years old.
Inclusion Criteria:- Evidence of recurrent or persistent hematologic malignancy following HLA matched allogeneic hematopoietic cell transplant - eligible for DLI - no evidence of GVHD - stable immunosuppressive regimen - adequate renal and liver function Exclusion Criteria:- CML patients who have not received DLI, active infections
|Official title||Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation|
|Principal investigator||Robert S Negrin|
Call for more information