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

• Conditions: Long-term Effects Secondary to Cancer Therapy in Adults; Lymphoma

• Registration Number: NCT00400907
• Lead Sponsor: German High-Grade Non-Hodgkin's Lymphoma Study Group

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.

Study Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-11-16
• Study First Submitted QC: 2006-11-16
• Study First Posted: 2006-11-17
• Status Verified: 2007-01
• Last Update Submitted: 2011-12-17
• Last Update Posted: 2011-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 667

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Time to treatment failure

Secondary Outcome Measures

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