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
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
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
NCT ID
NCT00400907
First Posted
November 16, 2006
Last Updated
December 17, 2011
Sponsor
German High-Grade Non-Hodgkin's Lymphoma Study Group
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
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Observation in Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Treated on Clinical Trial CAN-NCIC-LY9
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