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

NCT ID: NCT00097565

Last Updated: 2017-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2740 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-03-31

Study Completion Date

2014-03-31

Brief Summary

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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

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Conditions

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Lymphoma, Non Hodgkin

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Genentech, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cinical Trials

Role: STUDY_DIRECTOR

Genentech, Inc.

References

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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.

Reference Type DERIVED
PMID: 26729445 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26105149 (View on PubMed)

Other Identifiers

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U2963n

Identifier Type: -

Identifier Source: org_study_id

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