Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2026-01-25 @ 1:59 PM
Study NCT ID:
NCT01057459
Status:
COMPLETED
Last Update Posted:
2017-06-27
First Post:
2010-01-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DNA Analysis in Predicting Response to Antibody Therapy in Patients With Follicular Lymphoma Treated on Clinical Trials CALGB-50402 or CALGB-50701
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Study Overview
Official Title:
Natural Killer Cell KIR and HLA Genotypes May Predict Response to Antibody Therapy in Follicular Lymphoma
Status:
COMPLETED
Status Verified Date:
2017-06
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:
This research trial studies deoxyribonucleic acid (DNA) analysis in predicting response to antibody therapy in patients with follicular lymphoma treated on clinical trials Cancer and Leukemia Group B (CALGB)-50402 or CALGB-50701. Studying samples of blood from patients with follicular lymphoma in the laboratory may help doctors predict how well patients will respond to treatment.
Detailed Description:
PRIMARY OBJECTIVES:
l. To test the hypothesis that killer immunoglobulin-like receptor (KIR) and human leukocyte antigen (HLA) genotypes predict overall response (partial response \[PR\], complete response\[CR\], and unconfirmed complete response \[CRu\]) within 12 months to rituximab-containing monoclonal antibody combinations in follicular lymphoma patients treated on CALGB protocols 50402 and 50701.
SECONDARY OBJECTIVES:
I. To test the hypothesis that KIR and HLA genotypes are associated with survival outcomes (progression-free survival \[PFS\] and overall survival \[OS\]) in follicular lymphoma patients treated with rituximab-containing monoclonal antibody combinations on CALGB protocols 50402 and 50701.
OUTLINE:
Genomic DNA is extracted from previously collected blood samples for KIR and HLA genotyping and polymorphism analysis.
l. To test the hypothesis that killer immunoglobulin-like receptor (KIR) and human leukocyte antigen (HLA) genotypes predict overall response (partial response \[PR\], complete response\[CR\], and unconfirmed complete response \[CRu\]) within 12 months to rituximab-containing monoclonal antibody combinations in follicular lymphoma patients treated on CALGB protocols 50402 and 50701.
SECONDARY OBJECTIVES:
I. To test the hypothesis that KIR and HLA genotypes are associated with survival outcomes (progression-free survival \[PFS\] and overall survival \[OS\]) in follicular lymphoma patients treated with rituximab-containing monoclonal antibody combinations on CALGB protocols 50402 and 50701.
OUTLINE:
Genomic DNA is extracted from previously collected blood samples for KIR and HLA genotyping and polymorphism analysis.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000664103 | None | None | View | |
| NCI-2011-02204 | REGISTRY | NCI Physician Data Query | View | |
| U10CA180821 | NIH | None | https://reporter.nih.gov/quic… | View |