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

Sponsored by:	German High-Grade Non-Hodgkin's Lymphoma Study Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00400907

Purpose

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	Intervention
Long-Term Effects Secondary to Cancer Therapy in Adults Lymphoma	Procedure: management of therapy complications Procedure: observation

Study Type:	Observational
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]

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to treatment failure

Secondary Outcome Measures:

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

Estimated Enrollment:	667
Study Start Date:	January 2006

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00400907

Sponsors and Collaborators

German High-Grade Non-Hodgkin's Lymphoma Study Group

Investigators

Study Chair:

Michael G.M. Pfreundschuh, MD

Universitaetsklinikum des Saarlandes

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000514350, DSHNHL-MINT-FU, EU-20656, DSHNHL-M39045
Study First Received:	November 16, 2006
Last Updated:	May 9, 2009
ClinicalTrials.gov Identifier:	NCT00400907 History of Changes
Health Authority:	United States: Federal Government

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

Study placed in the following topic categories:

Lymphoma, Large B-Cell, Diffuse
Immunoproliferative Disorders
Rituximab
Lymphoma, B-Cell
Lymphoma, Small Cleaved-cell, Diffuse
Lymphatic Diseases
Antibodies

B-cell Lymphomas
Neoplasm Metastasis
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Lymphoma, Large-cell
Lymphoma
Immunoglobulins

Additional relevant MeSH terms:

Lymphoma, B-Cell
Lymphatic Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Immunoproliferative Disorders

Neoplasms by Histologic Type
Immune System Diseases
Neoplasm Metastasis
Lymphoproliferative Disorders
Lymphoma, Non-Hodgkin
Lymphoma

ClinicalTrials.gov processed this record on September 03, 2009