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

Alliance for Clinical Trials in Oncology

Status: Completed

Conditions: Lymphoma

Treatments: Genetic: fluorescence in situ hybridization; Genetic: cytogenetic analysis; Genetic: comparative genomic hybridization; Genetic: gene rearrangement analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00003863

CDR0000067027 (Registry Identifier)

CALGB-9764

U10CA076001 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 391 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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:

• 18 years and older

Trial design

391 participants in 1 patient group

Group 1

Description:

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.

Treatment:

Genetic: cytogenetic analysis

Genetic: comparative genomic hybridization

Genetic: fluorescence in situ hybridization

Genetic: gene rearrangement analysis