NCT00097565

Brief Summary

This is a prospective, observational, longitudinal, multicenter study of patients with newly diagnosed follicular Non Hodgkin's Lymphoma (NHL) designed to delineate differences in clinical outcome by comparing the effectiveness and safety of common treatment regimens.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2,740

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2004

Longer than P75 for all trials

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

Study Start

First participant enrolled

March 1, 2004

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 25, 2004

Completed
9.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2014

Completed
Last Updated

March 23, 2017

Status Verified

March 1, 2017

Enrollment Period

10 years

First QC Date

November 24, 2004

Last Update Submit

March 21, 2017

Conditions

Keywords

Follicular Non-Hodgkin's Lymphoma

Eligibility Criteria

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

Patients with follicular NHL will be recruited from participating managed care organizations, community physicians or practices, and academic centers throughout the United States.

You may qualify if:

  • Signed Informed Consent Form (unless the Institutional Review Board \[IRB\] has granted a waiver of consent)
  • Signed Authorization for the Use and Disclosure of Health Information document
  • Age ≥18 years
  • Histologic documentation of follicular NHL, according to Revised European-American Lymphoma (REAL) classification system, as assessed by the local pathologist and treating physician
  • Initial diagnosis of follicular B-cell NHL within 6 months prior to enrollment
  • Availability of cancer-specific historical data points in the patient's medical records

You may not qualify if:

  • Other indolent or histologic NHL subtypes
  • Diagnosis of lymphoma \> 6 months prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Nastoupil LJ, Sinha R, Byrtek M, Ziemiecki R, Zhou X, Taylor M, Friedberg JW, Link BK, Cerhan JR, Dawson K, Flowers CR. Outcomes following watchful waiting for stage II-IV follicular lymphoma patients in the modern era. Br J Haematol. 2016 Mar;172(5):724-34. doi: 10.1111/bjh.13895. Epub 2016 Jan 5.

  • Wagner-Johnston ND, Link BK, Byrtek M, Dawson KL, Hainsworth J, Flowers CR, Friedberg JW, Bartlett NL. Outcomes of transformed follicular lymphoma in the modern era: a report from the National LymphoCare Study (NLCS). Blood. 2015 Aug 13;126(7):851-7. doi: 10.1182/blood-2015-01-621375. Epub 2015 Jun 23.

MeSH Terms

Conditions

Lymphoma, Non-HodgkinLymphoma, Follicular

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Cinical Trials

    Genentech, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2004

First Posted

November 25, 2004

Study Start

March 1, 2004

Primary Completion

March 1, 2014

Study Completion

March 1, 2014

Last Updated

March 23, 2017

Record last verified: 2017-03