This trial is active, not recruiting.

Conditions long-term effects secondary to cancer therapy in adults, lymphoma
Treatments clinical observation, management of therapy complications
Sponsor German High-Grade Non-Hodgkin's Lymphoma Study Group
Start date January 2006
Trial size 667 participants
Trial identifier NCT00400907, CDR0000514350, DSHNHL-M39045, DSHNHL-MINT-FU, EU-20656


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.

United States No locations recruiting
Other countries No locations recruiting

Primary Outcomes

Time to treatment failure
time frame:

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

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]
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).