Observation in Patients With Diffuse Large B-Cell Non-Hodgkin's Lymphoma Treated on Clinical Trial CAN-NCIC-LY9
|ClinicalTrials.gov Identifier: NCT00400907|
Recruitment Status : Unknown
Verified January 2007 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : November 17, 2006
Last Update Posted : December 20, 2011
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.
|Condition or disease||Intervention/treatment|
|Long-term Effects Secondary to Cancer Therapy in Adults Lymphoma||Other: clinical observation Procedure: management of therapy complications|
- 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 Type :||Observational|
|Estimated Enrollment :||667 participants|
|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 Start Date :||January 2006|
- Time to treatment failure
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400907
|Study Chair:||Michael G.M. Pfreundschuh, MD||Universitaetsklinikum des Saarlandes|