drugset / Trial / NCT00324467

Tailoring Treatment for B Cell Non-hodgkin's Lymphoma Based on PET Scan Results Mid Treatment

NCT00324467

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard salvage regimen R-ICE (rituximab, ifosfamide, carboplatin, etoposide). Patients who have a negative PET scan after 4 cycles of R-CHOP have an excellent prognosis (\>85% chance of cure) and should complete treatment with 6 cycles of standard R-CHOP. Patients who have a positive PET scan after 4 cycles of R-CHOP have a very poor prognosis (\~10% chance of cure) and may have an improved outcome if switched to a non-cross resistant chemotherapy combination R-ICE.

Timeline

Start
2006-08
Primary completion
2021-12
Completion
2021-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule 800 mg Intravenous
Comparator Cyclophosphamide Other / unclassified 750 mg/m2 Intravenous
Comparator Doxorubicin Other / unclassified 50 mg/m2 Intravenous
Comparator Etoposide Small molecule 100 mg/m2 Intravenous
Comparator Ifosfamide Small molecule 5000 mg/m2 Intravenous
Comparator Prednisone Other / unclassified 45 mg/m2 Intravenous
Comparator Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Comparator Vincristine Small molecule 1.4 mg/m2 Intravenous
Comparator 2-MERCAPTOETHANESULFONIC ACID Small molecule 2 g Intravenous
Comparator 2-MERCAPTOETHANESULFONIC ACID Small molecule 5000 mg/m2 Intravenous
Comparator Acetaminophen Small molecule 650 mg Oral
Comparator Dexamethasone Small molecule 8 mg Oral
Comparator Dexamethasone Small molecule 12 mg Oral
Comparator Diphenhydramine Unknown 50 mg Oral
Comparator Ondansetron Other / unclassified 8 mg Oral