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Observation in Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Treated on Clinical Trial CAN-NCIC-LY9

NCT ID: NCT00400907

Last Updated: 2011-12-20

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

UNKNOWN

Total Enrollment

667 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-01-31

Brief Summary

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RATIONALE: Treatment for diffuse large B-cell non-Hodgkin's lymphoma may cause side effects and secondary cancers later in life. An observational study that evaluates patients after undergoing six courses of combination chemotherapy with or without rituximab and radiation therapy may help doctors predict a patient's response to this treatment and help plan the best treatment.

PURPOSE: This observational study is evaluating patients with diffuse large B-cell non-Hodgkin's lymphoma to see how well treatment on clinical trial CAN-NCIC-LY9 works.

Detailed Description

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OBJECTIVES:

* Gain information on the long-term efficacy of 6 courses of CHOP (cyclophosphamide, doxorubicin hydrochloride, prednisone, and vincristine)-like chemotherapy with vs without rituximab (plus involved-field radiotherapy to primary bulky disease) in young patients with good-prognosis diffuse large B-cell non-Hodgkin's lymphoma treated on protocol CAN-NCIC-LY9.
* Gain information on late toxicities, including secondary neoplasm occurring in young good-prognosis patients treated on protocol CAN-NCIC-LY9.

OUTLINE: This is a multicenter study.

Patients successfully completing treatment on protocol CAN-NCIC-LY9 are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 667 patients will be accrued for this study.

Conditions

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Long-term Effects Secondary to Cancer Therapy in Adults Lymphoma

Keywords

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long-term effects secondary to cancer therapy in adults stage I adult diffuse large cell lymphoma contiguous stage II adult diffuse large cell lymphoma noncontiguous stage II adult diffuse large cell lymphoma stage III adult diffuse large cell lymphoma stage IV adult diffuse large cell lymphoma

Interventions

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clinical observation

Intervention Type OTHER

management of therapy complications

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Patients recruited for protocol CAN-NCIC-LY9 and evaluated in the first planned final analysis as of June 2005

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German High-Grade Non-Hodgkin's Lymphoma Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Michael G.M. Pfreundschuh, MD

Role: STUDY_CHAIR

Universitaetsklinikum des Saarlandes

References

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Pfreundschuh M, Kuhnt E, Trumper L, Osterborg A, Trneny M, Shepherd L, Gill DS, Walewski J, Pettengell R, Jaeger U, Zinzani PL, Shpilberg O, Kvaloy S, de Nully Brown P, Stahel R, Milpied N, Lopez-Guillermo A, Poeschel V, Grass S, Loeffler M, Murawski N; MabThera International Trial (MInT) Group. CHOP-like chemotherapy with or without rituximab in young patients with good-prognosis diffuse large-B-cell lymphoma: 6-year results of an open-label randomised study of the MabThera International Trial (MInT) Group. Lancet Oncol. 2011 Oct;12(11):1013-22. doi: 10.1016/S1470-2045(11)70235-2. Epub 2011 Sep 21.

Reference Type RESULT
PMID: 21940214 (View on PubMed)

Other Identifiers

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DSHNHL-MINT-FU

Identifier Type: -

Identifier Source: secondary_id

EU-20656

Identifier Type: -

Identifier Source: secondary_id

DSHNHL-M39045

Identifier Type: -

Identifier Source: secondary_id

CDR0000514350

Identifier Type: -

Identifier Source: org_study_id