Skip to main content
OpenTrials
Completed

NCT Number: NCT00003863

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 18 years and older

Treatment and study plan

comparative genomic hybridization

Genetic

cytogenetic analysis

Genetic

fluorescence in situ hybridization

Genetic

gene rearrangement analysis

Genetic

Primary outcomes

  1. response to therapy

    Time frame: Up to 5 years

Secondary outcomes

  1. failure-free survival

    Time frame: Up to 5 years

  2. overall survival

    Time frame: Up to 5 years

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Genetic Changes in Diffuse Aggressive Non-Hodgkin's Lymphoma

Important dates

Study start
1999
Primary completion
2005
Study completion
2005
First posted
Jan 27, 2003
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.