Molecular Risk Guided Treatment Of Diffuse Large B-Cell Non-Hodgkin's Lymphoma
- 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.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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.
Results from the genetic testing and PET scans at baseline and after course 3 to determine response.
Omer N. Koc, MD
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
United States: Federal Government
|Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|