An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma

• ClinicalTrials.gov Identifier: NCT00097565
• Recruitment Status: Completed
• First Posted: November 25, 2004
• Last Update Posted: March 23, 2017
• Sponsor: Genentech, Inc.
• Information provided by (Responsible Party): Genentech, Inc.

Tracking Information

• First Submitted Date: November 24, 2004
• First Posted Date: November 25, 2004
• Last Update Posted Date: March 23, 2017
• Actual Study Start Date: March 2004
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma
• Official Title: The National Lymphocare Study: An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-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.
• Condition: Lymphoma, Non Hodgkin
• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided

Publications *

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 1, 2013): 2740
• Original Enrollment (submitted: June 23, 2005): 5000
• Actual Study Completion Date: March 2014
• Actual Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided
• Removed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT00097565
• Other Study ID Numbers: U2963n
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Genentech, Inc.
• Study Sponsor: Genentech, Inc.
• Collaborators: Not Provided

Investigators

• Study Director: Cinical Trials; Genentech, Inc.

• PRS Account: Genentech, Inc.
• Verification Date: March 2017