Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00145626
Status:
COMPLETED
Last Update Posted:
2017-06-19
First Post:
2005-09-01
Brief Title:
HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
Sponsor:
St Jude Childrens Research Hospital
Organization:
St Jude Childrens Research Hospital
Study Overview
Official Title:
HLA-Nonidentical Stem Cell and Natural Killer Cell Transplantation for Children Less the Two Years of Age With Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Recent studies of conventional chemotherapy for infants with high-risk hematologic malignancies show that the long-term disease-free survival is low Although blood and marrow stem cell transplantation using an HLA identical sibling has improved the outcome for these children less than 25 have this donor source available Another option is haploidentical transplantation using a partially matched family member donor ie parental donor
Although haploidentical transplantation has proven curative for some patients this procedure has been hindered by significant complications primarily regimen-related toxicity including infection and graft versus host disease GVHD Building on prior institutional trials this study will provide patients a haploidentical graft depleted of T lymphocytes using the investigational device CliniMACS selection system One week after the transplant procedure patients will also receive an infusion of additional donor derived white blood cells called Natural Killer NK cells in an effort to decrease risks for rejection of the graft disease relapse and regimen related toxicity The primary objective of the study is to evaluate 1 year survival in infants with high risk hematologic malignancies who receive this study treatment
Although haploidentical transplantation has proven curative for some patients this procedure has been hindered by significant complications primarily regimen-related toxicity including infection and graft versus host disease GVHD Building on prior institutional trials this study will provide patients a haploidentical graft depleted of T lymphocytes using the investigational device CliniMACS selection system One week after the transplant procedure patients will also receive an infusion of additional donor derived white blood cells called Natural Killer NK cells in an effort to decrease risks for rejection of the graft disease relapse and regimen related toxicity The primary objective of the study is to evaluate 1 year survival in infants with high risk hematologic malignancies who receive this study treatment
Detailed Description:
Secondary objectives for this study include the following
To estimate the incidence of three transplant-related adverse outcomes ie regimen-related mortality engraftment failure and fatal acute GVHD in the first 100 days after transplantation
To estimate the incidence of chronic graft-versus-host disease
To evaluate those factors that affect one-year survival
To assess the kinetics of lymphohematopoietic reconstitution
To assess the frequency and clinical relevance of minimal residual disease MRD before and after transplantation
To evaluate the incidence of and risk factors for long-term neurocognitive deficit and organ dysfunction
To estimate the incidence of three transplant-related adverse outcomes ie regimen-related mortality engraftment failure and fatal acute GVHD in the first 100 days after transplantation
To estimate the incidence of chronic graft-versus-host disease
To evaluate those factors that affect one-year survival
To assess the kinetics of lymphohematopoietic reconstitution
To assess the frequency and clinical relevance of minimal residual disease MRD before and after transplantation
To evaluate the incidence of and risk factors for long-term neurocognitive deficit and organ dysfunction
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2011-03671 | REGISTRY | NCI Clinical Trial Registration Program | None |