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

Lymphoma Clinical Trial

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]

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00400907
• Other study ID #: CDR0000514350
• Secondary ID: DSHNHL-MINT-FUEU
• Status: Active, not recruiting
• Phase: N/A
• First received: November 16, 2006
• Last updated: December 17, 2011
• Start date: January 2006

Study information

• Verified date: January 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 667
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

N/A

Related Conditions & MeSH terms

• Long-term Effects Secondary to Cancer Therapy in Adults
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin

Intervention

Other:
• clinical observation

Procedure:
• management of therapy complications

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
German High-Grade Non-Hodgkin's Lymphoma Study Group

References & Publications (1)

Pfreundschuh M, Kuhnt E, Trümper 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, López-Guillermo A, Poeschel V, Grass S, Loeffler M, Murawski N; M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to treatment failure
Secondary	Complete remission rate
Secondary	Relapse rate
Secondary	Overall survival
Secondary	Tumor control
Secondary	Disease-free survival
Secondary	Time to progression
Secondary	Time to relapse
Secondary	Late toxicities, particularly organ function deficiencies (e.g., cardiomyopathies), infections, and secondary neoplasms