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Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma

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Trial Information

Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma


OBJECTIVES:

- Determine whether molecular risk assessment can identify groups of patients with
diffuse large B-cell non-Hodgkin's lymphoma (NHL) who will demonstrate at least 50%
difference in early response rates to treatment as determined by positron-emission
tomography (PET) imaging.

- Determine, by PET imaging, the response rate of patients treated with cyclophosphamide,
doxorubicin, vincristine, prednisone, and rituximab.

- Determine whether early response rates can be predicted by gene expression profiles at
diagnosis in these patients.

- Compare gene expression profiles of patients with refractory or relapsed large cell NHL
with profiles of the disease at diagnosis.

- Determine relapse-free and overall survival rates of these patients.

- Determine the feasibility of a new NHL treatment algorithm based on prognostic index
and molecular risk, and early response assessment by PET imaging.

OUTLINE: Molecular risk assessment is performed using lymph node tissue from initial
diagnosis to test for "activated" genes before starting treatment.

Patients receive rituximab IV over 3-6 hours, cyclophosphamide IV over 30 minutes,
doxorubicin IV over 5 minutes, and vincristine IV over 5 minutes on day 1 and oral
prednisone on days 1-5. Treatment repeats every 21 days for 3-8 courses. Patients undergo
whole-body positron-emission tomography (PET) scanning at baseline and after course 3 to
determine response. Results from the genetic testing and PET scans are used to determine
further treatment recommendations.

Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

PROJECTED ACCRUAL: A total of 36-50 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed diffuse large B-cell non-Hodgkin's lymphoma

- CD20 and/or CD19 positive by immunohistochemistry or flow cytometry

- Disease evaluable by positron-emission tomography scan

- Diagnostic tissue (either frozen or fresh unfixed) available for molecular testing or
willing to undergo a repeat procedure to obtain such tissue

- No CNS involvement by lymphoma

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Not specified

Life expectancy

- Not specified

Hematopoietic

- Not specified

Hepatic

- Bilirubin no greater than 3 mg/dL

Renal

- Creatinine no greater than 3 mg/dL

Cardiovascular

- LVEF at least 40%

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception

- No significant organ dysfunction that would preclude study chemotherapy

- HIV negative

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior immunotherapy

- No prior biological response modifier therapy

Chemotherapy

- No prior chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior radiotherapy

- No prior radioimmunotherapy

Surgery

- Not specified

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Molecular risk assessment to see how well it works in predicting response to therapy in patients who are receiving treatment for non-Hodgkin's lymphoma.

Outcome Time Frame:

Results from the genetic testing and PET scans at baseline and after course 3 to determine response.

Safety Issue:

No

Principal Investigator

Omer N. Koc, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CWRU1402

NCT ID:

NCT00055640

Start Date:

October 2002

Completion Date:

March 2006

Related Keywords:

  • Lymphoma
  • stage I adult diffuse large cell lymphoma
  • contiguous stage II adult diffuse large cell lymphoma
  • stage III adult diffuse large cell lymphoma
  • noncontiguous stage II adult diffuse large cell lymphoma
  • stage IV adult diffuse large cell lymphoma
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell

Name

Location

Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065