Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00161187
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2005-09-08
Brief Title:
Irradiated Donor Lymphocyte Infusion in Treating Patients With Relapsed or Refractory Hematologic Cancer or Solid Tumor
Sponsor:
University of Medicine and Dentistry of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
A Pilot Study of Irradiated HLA-Partially Matched Allogeneic Related Donor Lymphocytes for Patients With Selected Malignancies
Status:
COMPLETED
Status Verified Date:
2013-09
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 When irradiated lymphocytes from a donor are infused into the patient they may help the patients immune system kill cancer cells
PURPOSE This pilot study is looking at the side effects and how well irradiated donor lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer or solid tumor
PURPOSE This pilot study is looking at the side effects and how well irradiated donor lymphocyte infusion works in treating patients with relapsed or refractory hematologic cancer or solid tumor
Detailed Description:
OBJECTIVES
Determine the toxicity of irradiated allogeneic donor lymphocyte infusion in patients with relapsed or refractory hematological cancer or solid tumor
Determine the response in patients treated with this regimen
Determine the presence of disease or antigen-specific lymphocytes in patients treated with this regimen
OUTLINE This is a pilot open-label controlled study
Patients undergo irradiated allogeneic donor lymphocyte infusion over 1 hour on day 1 Treatment repeats every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity
Blood samples are collected periodically and analyzed for lymphocytotoxicity directed towards patients cells normal and malignant cells and for disease or antigen-specific cells Samples are also analyzed for survival of donor lymphocytes by chimerism studies
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Determine the toxicity of irradiated allogeneic donor lymphocyte infusion in patients with relapsed or refractory hematological cancer or solid tumor
Determine the response in patients treated with this regimen
Determine the presence of disease or antigen-specific lymphocytes in patients treated with this regimen
OUTLINE This is a pilot open-label controlled study
Patients undergo irradiated allogeneic donor lymphocyte infusion over 1 hour on day 1 Treatment repeats every 8-16 weeks for up to 6 infusions in the absence of disease progression or unacceptable toxicity
Blood samples are collected periodically and analyzed for lymphocytotoxicity directed towards patients cells normal and malignant cells and for disease or antigen-specific cells Samples are also analyzed for survival of donor lymphocytes by chimerism studies
PROJECTED ACCRUAL A total of 40 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 |
|---|---|---|---|
| CDR0000540298 | OTHER | NIH | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |
| 0220003330 | OTHER | None | None |