Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00450983
Status:
TERMINATED
Last Update Posted:
2017-05-24
First Post:
2007-03-20
Brief Title:
Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation Thiotepa Fludarabine and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
Transplantation of Haploidentical CD34 Purified Peripheral Blood Stem Cells With NK-Cell Add-Back Following Conditioning With Total Body Irradiation Thiotepa Fludarabine and OKT3
Status:
TERMINATED
Status Verified Date:
2017-04
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:
RATIONALE Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell and donor natural killer cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patients immune system from rejecting the donors stem cells When certain stem cells from a donor are infused into the patient they may help the patients bone marrow make stem cells red blood cells white blood cells and platelets Sometimes the transplanted cells from a donor can make an immune response against the bodys normal cells Removing the T cells from the donor cells before transplant may stop this from happening
PURPOSE This phase II trial is studying how well giving a donor peripheral stem cell transplant and a donor natural killer cell transplant after total-body irradiation thiotepa fludarabine and muromonab-CD3 works in treating patients with leukemia or other blood diseases
PURPOSE This phase II trial is studying how well giving a donor peripheral stem cell transplant and a donor natural killer cell transplant after total-body irradiation thiotepa fludarabine and muromonab-CD3 works in treating patients with leukemia or other blood diseases
Detailed Description:
OBJECTIVES
Primary
Determine the effect of haploidentical donor CD34 purified peripheral blood stem cells and donor natural killer NK cells on the risk of developing grades III-IV acute graft-vs-host disease in patients with leukemia or other hematologic diseases
Secondary
Determine the risk for mortality from infection before day 180 in patients treated with this regimen
Determine the risk for graft rejection in patients treated with this regimen
Determine the risk for life-threatening infections in patients treated with this regimen
Determine the concentration of subsets of NK NK-T T cells and dendritic cells in the CD34 NKNK-T-enriched graft
Determine cytomegalovirus-specific T-cells in product and donor graft
Determine the genotype and phenotype of donor killer cell immunoglobulin-like receptor expression according to time after hematopoietic stem cell transplantation HSCT
Determine the reconstitution of NK function according to time after HSCT
Determine the expression of NKG2 ligands of leukemic blasts
OUTLINE Patients are stratified according to age 7 years vs 7 years
Conditioning regimen Patients 7 years of age or younger undergo total-body irradiation TBI twice daily on days -11 to -9 Patients over 7 years of age undergo TBI once on day -9 All patients receive thiotepa IV over 2 hours on days -8 and -7 fludarabine phosphate IV on days -6 to -3 and muromonab-CD3 on days -6 to 6 Patients with acute lymphoblastic leukemia or leukemia in the spinal fluid also receive methotrexate intrathecally prior to and after donor peripheral blood stem cell PBSC transplantation
Donor PBSC transplantation Patients undergo donor PBSC transplantation comprising CD34 purified PBSCs and natural killer NK cells on day 0
Blood samples are collected in weeks 1-4 6 8 and 12 Analysis of samples includes quantitation of NK NK-T and T-cell subsets CD3 CD4 and CD8 by flow cytometry donor killer cell immunoglobulin-like receptor genotype and phenotype interferon-gamma levels and NK cytotoxicity Samples are also analyzed by leukemic blast assay to determine if ligands that activate NK cells are expressed
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Determine the effect of haploidentical donor CD34 purified peripheral blood stem cells and donor natural killer NK cells on the risk of developing grades III-IV acute graft-vs-host disease in patients with leukemia or other hematologic diseases
Secondary
Determine the risk for mortality from infection before day 180 in patients treated with this regimen
Determine the risk for graft rejection in patients treated with this regimen
Determine the risk for life-threatening infections in patients treated with this regimen
Determine the concentration of subsets of NK NK-T T cells and dendritic cells in the CD34 NKNK-T-enriched graft
Determine cytomegalovirus-specific T-cells in product and donor graft
Determine the genotype and phenotype of donor killer cell immunoglobulin-like receptor expression according to time after hematopoietic stem cell transplantation HSCT
Determine the reconstitution of NK function according to time after HSCT
Determine the expression of NKG2 ligands of leukemic blasts
OUTLINE Patients are stratified according to age 7 years vs 7 years
Conditioning regimen Patients 7 years of age or younger undergo total-body irradiation TBI twice daily on days -11 to -9 Patients over 7 years of age undergo TBI once on day -9 All patients receive thiotepa IV over 2 hours on days -8 and -7 fludarabine phosphate IV on days -6 to -3 and muromonab-CD3 on days -6 to 6 Patients with acute lymphoblastic leukemia or leukemia in the spinal fluid also receive methotrexate intrathecally prior to and after donor peripheral blood stem cell PBSC transplantation
Donor PBSC transplantation Patients undergo donor PBSC transplantation comprising CD34 purified PBSCs and natural killer NK cells on day 0
Blood samples are collected in weeks 1-4 6 8 and 12 Analysis of samples includes quantitation of NK NK-T and T-cell subsets CD3 CD4 and CD8 by flow cytometry donor killer cell immunoglobulin-like receptor genotype and phenotype interferon-gamma levels and NK cytotoxicity Samples are also analyzed by leukemic blast assay to determine if ligands that activate NK cells are expressed
After completion of study therapy patients are followed periodically
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000533834 | REGISTRY | PDQ | httpsreporternihgovquickSearchP30CA015704 |
| R01AI053193 | NIH | None | None |
| P30CA015704 | NIH | None | None |
| FHCRC-196500 | None | None | None |