drugset / Trial / NCT00809341

R-ICE and High-Dose Cyclophosphamide With PET/CT for Diffuse Large B-Cell Non-Hodgkin's Lymphoma

NCT00809341

Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2009-01
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule
Comparator Cyclophosphamide Other / unclassified 50 mg/kg
Comparator Cyclophosphamide Other / unclassified 750 mg/m2
Comparator Doxorubicin Other / unclassified 50 mg/m2
Comparator Etoposide Small molecule 100 mg/m2
Comparator Ifosfamide Small molecule 2000 mg/m2
Comparator Prednisone Other / unclassified 100 mg
Comparator Rituximab Monoclonal antibody 375 mg/m2
Comparator Vincristine Small molecule 1.4 mg/m2

Indications