NCT01057459

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 27, 2010

Completed
5 days until next milestone

Study Start

First participant enrolled

February 1, 2010

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2014

Completed
Last Updated

June 27, 2017

Status Verified

June 1, 2017

Enrollment Period

4.4 years

First QC Date

January 26, 2010

Last Update Submit

June 26, 2017

Conditions

Lymphoma

Keywords

Stage II Grade 1 Contiguous Follicular LymphomaStage II Grade 1 Non-Contiguous Follicular LymphomaStage II Grade 2 Contiguous Follicular LymphomaStage II Grade 2 Non-Contiguous Follicular LymphomaStage II Grade 3 Contiguous Follicular LymphomaStage II Grade 3 Non-Contiguous Follicular Lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphoma

Outcome Measures

Primary Outcomes (1)

  • overall response

    Baseline

Secondary Outcomes (2)

  • Progression-free survival

    Baseline

  • Overall survival

    Baseline

Study Arms (1)

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

laboratory biomarker analysisOTHER

Correlative studies

Ancillary-Correlative (biomarkers and treatment outcomes)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

LymphomaLymphoma, Follicular

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesLymphoma, Non-Hodgkin

Study Officials

  • Jeffrey Venstrom, MD

    Memorial Sloan Kettering Cancer Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2010

First Posted

January 27, 2010

Study Start

February 1, 2010

Primary Completion

June 23, 2014

Study Completion

June 23, 2014

Last Updated

June 27, 2017

Record last verified: 2017-06

Locations

US(1)