Diagnostic Study of Patients With Aggressive Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003863
First received: November 1, 1999
Last updated: April 11, 2009
Last verified: May 2006
  Purpose

RATIONALE: Determination of genetic markers for aggressive non-Hodgkin's lymphoma may help identify patients with this disease and help predict the outcome of treatment.

PURPOSE: Diagnostic study to determine the genetic markers in patients who have aggressive non-Hodgkin's lymphoma.


Condition Intervention
Lymphoma
Genetic: comparative genomic hybridization
Genetic: cytogenetic analysis
Genetic: fluorescence in situ hybridization
Genetic: gene rearrangement analysis

Study Type: Interventional
Study Design: Primary Purpose: Diagnostic
Official Title: Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma

Resource links provided by NLM:


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

Study Start Date: June 1999
Detailed Description:

OBJECTIVES:

  • Estimate the proportions of patients with diffuse aggressive non-Hodgkin's lymphoma who have rearrangements affecting the MYC, BCL2, and BCL6 genes (determined by fluorescent in situ hybridization), overtly amplified chromosomal regions, and nonrandom copy number changes of chromosomal regions (determined by comparative genomic hybridization).
  • Investigate the prognostic importance of these genetic markers by studying their relationships with clinical outcomes (e.g., response to therapy, failure-free survival, and overall survival) in these patients.
  • Investigate the interrelationships among these genetic and biological markers and their relationships with clinical features of the disease, such as disease site (nodal vs extranodal) and stage, in these patients.

OUTLINE: This is a multicenter study.

Tissue samples are obtained before treatment and at the time of documentation of refractory disease in patients who do not achieve complete remission after induction therapy or at the time of first relapse in patients who achieve a complete remission.

Samples are examined for rearrangements in the MYC, BCL2, BCL6, and IGH genes using fluorescent in situ hybridization. DNA is examined by comparative genomic hybridization, which allows cytogenetic detection of losses and gains of chromosomal regions in tumor cells.

Patients do not receive the results of the genetic testing and the results do not influence the type or duration of treatment.

PROJECTED ACCRUAL: A total of 391 patients will be accrued for this study within 5 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically proven aggressive non-Hodgkin's lymphoma and registered to front-line CALGB protocols (e.g, CLB-59903, 59909, 10002, and 50103)

    • Diffuse small cleaved cell lymphoma
    • Diffuse mixed small and large cell lymphoma
    • Diffuse large cell lymphoma
    • Diffuse large cell immunoblastic lymphoma
    • Small noncleaved cell lymphoma
    • Mantle cell lymphoma OR
  • Previously entered on similar curative CALGB protocols (CLB-8852, CLB-8854, and CLB-9351) with blocks or unstained slides of initial diagnosis available

PATIENT CHARACTERISTICS:

Age:

  • Adult

Performance status:

  • Not specified

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • Not specified

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003863

  Show 69 Study Locations
Sponsors and Collaborators
Cancer and Leukemia Group B
Investigators
Study Chair: Raju S. K. Chaganti, PhD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003863     History of Changes
Other Study ID Numbers: CDR0000067027, CALGB-9764
Study First Received: November 1, 1999
Last Updated: April 11, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult Burkitt lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse large cell lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult Burkitt lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult Burkitt lymphoma
recurrent adult diffuse small cleaved cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult immunoblastic large cell lymphoma
recurrent adult Burkitt lymphoma
stage I mantle cell lymphoma
contiguous stage II adult diffuse small cleaved cell lymphoma
contiguous stage II mantle cell lymphoma
contiguous stage II adult diffuse mixed cell lymphoma
contiguous stage II adult immunoblastic large cell lymphoma
contiguous stage II adult diffuse large cell lymphoma
contiguous stage II adult Burkitt lymphoma
noncontiguous stage II adult diffuse small cleaved cell lymphoma
noncontiguous stage II mantle cell lymphoma
noncontiguous stage II adult diffuse mixed cell lymphoma

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

ClinicalTrials.gov processed this record on September 16, 2014