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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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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
Sponsor:
Information provided by:
National Cancer Institute (NCI)

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.


Condition or disease Intervention/treatment
Long-term Effects Secondary to Cancer Therapy in Adults Lymphoma Other: clinical observation Procedure: management of therapy complications

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 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





Primary Outcome Measures :
  1. Time to treatment failure

Secondary Outcome Measures :
  1. Complete remission rate
  2. Relapse rate
  3. Overall survival
  4. Tumor control
  5. Disease-free survival
  6. Time to progression
  7. Time to relapse
  8. Late toxicities, particularly organ function deficiencies (e.g., cardiomyopathies), infections, and secondary neoplasms


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00400907


Sponsors and Collaborators
German High-Grade Non-Hodgkin's Lymphoma Study Group
Investigators
Study Chair: Michael G.M. Pfreundschuh, MD Universitaetsklinikum des Saarlandes

Publications of Results:
ClinicalTrials.gov Identifier: NCT00400907     History of Changes
Other Study ID Numbers: CDR0000514350
DSHNHL-MINT-FU
EU-20656
DSHNHL-M39045
First Posted: November 17, 2006    Key Record Dates
Last Update Posted: December 20, 2011
Last Verified: January 2007

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases