DNA Analysis in Predicting Response to Antibody Therapy i... | NCT01057459

ID	Type	Description	Link
CDR0000664103
NCI-2011-02204	Registry Identifier	NCI Physician Data Query
U10CA180821	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010Actual

Primary Completion Date

Jun 23, 2014Actual

Completion Date

Jun 23, 2014Actual

First Submitted Date

Jan 26, 2010

First Submission Date that Met QC Criteria

Jan 26, 2010

First Posted Date

Jan 27, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 26, 2017

Last Update Posted Date

Jun 27, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

Alliance for Clinical Trials in OncologyOTHER

Collaborators

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

Lymphoma

Keywords

Stage II Grade 1 Contiguous Follicular Lymphoma
Stage II Grade 1 Non-Contiguous Follicular Lymphoma
Stage II Grade 2 Contiguous Follicular Lymphoma
Stage II Grade 2 Non-Contiguous Follicular Lymphoma
Stage II Grade 3 Contiguous Follicular Lymphoma
Stage II Grade 3 Non-Contiguous Follicular Lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ancillary-Correlative (biomarkers and treatment outcomes)		Genomic DNA is extracted from previously collected blood samples for KIR and HLA genotyping and polymorphism analysis.	Other: laboratory biomarker analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
laboratory biomarker analysis	Other	Correlative studies	Ancillary-Correlative (biomarkers and treatment outcomes)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
overall response		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Progression-free survival		Baseline
Overall survival		Baseline

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Untreated follicular lymphoma
Has received rituximab-containing monoclonal antibody therapy on CALGB-50402 or CALGB-50701
Patients have previously provided informed consent allowing correlative studies on genomic DNA

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients diagnosed with follicular lymphoma treated on CALGB 50402 or 50701 protocols

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeffrey Venstrom, MD	Memorial Sloan Kettering Cancer Center	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Memorial Sloan-Kettering Cancer Center		New York	New York	10065	United States

Derived Section

Miscellaneous Info Module

Version Holder

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

ID	Term
D008223	Lymphoma
D008224	Lymphoma, Follicular

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases
D008228	Lymphoma, Non-Hodgkin