R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma
This research is being done to see if a PET scan that is obtained after 3 cycles of a standard chemotherapy regimen can help guide treatment for patients with a blood disease called Non-Hodgkin's Lymphoma.
The standard treatment for newly diagnosed lymphoma is 6 to 8 cycles of chemotherapy like the CHOP combination (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone). This regimen can cure about half of patients with lymphoma, but in many others disease relapses (comes back). Relapses are generally treated with more chemotherapy.
We believe that a PET scan (a type of imaging study that "lights up" in areas of cells with high activity such as lymphoma), may identify patients early who are at high risk of relapse.
The purpose of this research study is to find out if people whose treatment is changed early to an intensification regimen (high dose chemotherapy) based on a positive PET scan will have longer remissions than they would if they did not receive that high dose chemotherapy.
|Non-Hodgkin's Lymphoma||Drug: R-CHOP, R-CHOEP, R-EPOCH Drug: R-ICE, Cyclophosphamide||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Treatment Intensification With R-ICE and High-Dose Cyclophosphamide for Diffuse Large B-Cell Non-Hodgkin's Lymphoma Based on Early [18F] FDG-PET Scanning|
- Estimate survival in patient receiving early treatment intensification based on a positive mid-treatment PET scan compared to the historical event-free survival of mid-treatment PET positive patients not given early treatment intensification. [ Time Frame: 2 years ]
- Estimate overall survival in patients whose treatment is determined on the basis of a mid-treatment [18F] FDG-PET scan result. [ Time Frame: 5 years ]
|Study Start Date:||January 2009|
|Study Completion Date:||April 2014|
|Primary Completion Date:||April 2014 (Final data collection date for primary outcome measure)|
Active Comparator: PET Negative
PET negative patients will complete conventional therapy under a treatment plan formulated by their primary oncologist. Decisions regarding subsequent therapy, including BMT for disease relapse, will also be at the discretion of the primary oncologist.
Drug: R-CHOP, R-CHOEP, R-EPOCH
Based on the PET-CT scan results patients will complete standard chemotherapy consisting of R-CHOP (or equivalent anthracycline-containing regimen (e.g. R-CHOEP, R-EPOCH)
Active Comparator: PET Positive
R-ICE x 2 cycles (outpatient regimen; Pre-high dose therapy evaluations during R-ICE cycles; Cyclophosphamide 50mg/kg/day day2-5; rituximab d1, 30, 37
Drug: R-ICE, Cyclophosphamide
Two cycles of R-ICE, followed by high dose cyclophosphamide and Rituximab
Patients will receive 3 cycles of chemotherapy prior to mid-treatment PET-CT. Rituximab-CHOP, or an equivalent regimen must be used. During the third cycle of Rituximab-CHOP chemotherapy, a PET-CT scan will be performed. The PET scan will be designated as negative or positive. Based on the results, patients will either complete standard dose therapy or receive two cycles of R-ICE followed by high dose cyclophosphamide and rituximab.
A repeat PET-CT is required between 4 to 6 weeks following treatment completion. Patients will be followed-up every 4 months for 2 years, then every 6 months for one year, then annually until 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00809341
|United States, Maryland|
|The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231|
|Principal Investigator:||Lode Swinnen, MD||Johns Hopkins University|