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

Primary Purpose

Long-term Effects Secondary to Cancer Therapy in Adults, Lymphoma

Status
Unknown status
Phase
Locations
Study Type
Observational
Intervention
clinical observation
management of therapy complications
Sponsored by
German High-Grade Non-Hodgkin's Lymphoma Study Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Long-term Effects Secondary to Cancer Therapy in Adults focused on measuring 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

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Time to treatment failure

    Secondary Outcome Measures

    Complete remission rate
    Relapse rate
    Overall survival
    Tumor control
    Disease-free survival
    Time to progression
    Time to relapse
    Late toxicities, particularly organ function deficiencies (e.g., cardiomyopathies), infections, and secondary neoplasms

    Full Information

    First Posted
    November 16, 2006
    Last Updated
    December 17, 2011
    Sponsor
    German High-Grade Non-Hodgkin's Lymphoma Study Group
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00400907
    Brief Title
    Observation in Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Treated on Clinical Trial CAN-NCIC-LY9
    Official Title
    Follow-up Observational Study of the Randomised Intergroup Trial of First Line Treatment for Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma With CHOP-Like Chemotherapy Regimen With or Without the Anti-CD20 Antibody Rituximab (IDEC-C2B8) [MINT]
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    January 2007
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    German High-Grade Non-Hodgkin's Lymphoma Study Group

    4. Oversight

    5. Study Description

    Brief Summary
    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Long-term Effects Secondary to Cancer Therapy in Adults, Lymphoma
    Keywords
    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

    7. Study Design

    Enrollment
    667 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Other
    Intervention Name(s)
    clinical observation
    Intervention Type
    Procedure
    Intervention Name(s)
    management of therapy complications
    Primary Outcome Measure Information:
    Title
    Time to treatment failure
    Secondary Outcome Measure Information:
    Title
    Complete remission rate
    Title
    Relapse rate
    Title
    Overall survival
    Title
    Tumor control
    Title
    Disease-free survival
    Title
    Time to progression
    Title
    Time to relapse
    Title
    Late toxicities, particularly organ function deficiencies (e.g., cardiomyopathies), infections, and secondary neoplasms

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael G.M. Pfreundschuh, MD
    Organizational Affiliation
    Universitaetsklinikum des Saarlandes
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    21940214
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

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