Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00176475
Status:
TERMINATED
Last Update Posted:
2013-09-17
First Post:
2005-09-12
Brief Title:
Irradiated Donor Lymphocytes and Rituximab in Treating Patients With Relapsed or Refractory Lymphoproliferative Disease
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 in Conjunction With Rituximab for Selected Patients With CD20 Malignancies
Status:
TERMINATED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow accrual
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 Monoclonal antibodies such as rituximab can block cancer growth in different ways Some block the ability of cancer cells to grow and spread Others find cancer cells and help kill them or carry cancer-killing substances to them Giving irradiated donor lymphocytes together with rituximab may kill more cancer cells
PURPOSE This clinical trial is studying the side effects and how well giving irradiated donor lymphocytes together with rituximab works in treating patients with relapsed or refractory lymphoproliferative disease
PURPOSE This clinical trial is studying the side effects and how well giving irradiated donor lymphocytes together with rituximab works in treating patients with relapsed or refractory lymphoproliferative disease
Detailed Description:
OBJECTIVES
Primary
Determine the toxicity of irradiated HLA-partially matched related donor lymphocytes when administered with rituximab in patients with relapsed or refractory CD20-positive lymphoproliferative disease
Determine the efficacy of this regimen in these patients
Secondary
Correlate response with Fc receptor FcγIIIA polymorphisms or predicted HLA-directed natural killer cell reactivity
OUTLINE This is a pilot study
Rituximab therapy Patients receive rituximab IV on days -1 6 13 and 20 Treatment repeats approximately every 4 months in the absence of disease progression or unacceptable toxicity
Donor lymphocyte infusion Patients receive irradiated donor lymphocytes IV over 1 hour on day 0 Treatment repeats every 8-16 weeks alternating with courses of rituximab therapy for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity
Peripheral blood is collected periodically during study for correlative laboratory studies Blood samples are analyzed for FcγIIIA polymorphism by fluorescent in situ hybridization or by reverse transcriptase-polymerase chain reaction Survival of donor lymphocytes is assessed by chimerism studies
PROJECTED ACCRUAL A total of 20 patients will be accrued for this study
Primary
Determine the toxicity of irradiated HLA-partially matched related donor lymphocytes when administered with rituximab in patients with relapsed or refractory CD20-positive lymphoproliferative disease
Determine the efficacy of this regimen in these patients
Secondary
Correlate response with Fc receptor FcγIIIA polymorphisms or predicted HLA-directed natural killer cell reactivity
OUTLINE This is a pilot study
Rituximab therapy Patients receive rituximab IV on days -1 6 13 and 20 Treatment repeats approximately every 4 months in the absence of disease progression or unacceptable toxicity
Donor lymphocyte infusion Patients receive irradiated donor lymphocytes IV over 1 hour on day 0 Treatment repeats every 8-16 weeks alternating with courses of rituximab therapy for up to 6 donor lymphocyte infusions in the absence of disease progression or unacceptable toxicity
Peripheral blood is collected periodically during study for correlative laboratory studies Blood samples are analyzed for FcγIIIA polymorphism by fluorescent in situ hybridization or by reverse transcriptase-polymerase chain reaction Survival of donor lymphocytes is assessed by chimerism studies
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 |
|---|---|---|---|
| CINJ-010406 | OTHER | Cancer Institute of New Jersey | httpsreporternihgovquickSearchP30CA072720 |
| P30CA072720 | NIH | None | None |