drugset / Trial / NCT00816959

Study Evaluating the Effect of R-mabHDI in Lymphocytic Predominant Hodgkin's Lymphoma

NCT00816959

RandomizedParallel-groupOpen-labelTreatment

Summary

Objective: The primary objective of the study is to evaluate the effect of R-mabHDI in patients with late stage, widespread stage and recurrent Lymphocytic Predominant Hodgkin's Lymphoma. The hypothesis is that the combination of R-mabHDI with the standard ABVD therapy in patients with late stage (Stage III and Stage IV) and recurrent stage Lymphocytic Predominant Hodgkin's Lymphoma will have a favorable outcome on the response and progress free survival. The study is also aimed at evaluating the safety of R-mabHDI . The aim of the study is to test this hypothesis by evaluating the clinical outcome in 1200 patients receiving combination of R-mabHDI once a week for 8 weeks and ABVD therapy every other week for 12 treatments.

Timeline

Start
2011-07
Primary completion
2014-04
Completion
2014-04

Drugs

EvaluationDrugModalityDoseRoute
Comparator R-mabHDI Unknown Intravenous
Comparator Bleomycin Unknown Intravenous
Comparator Dacarbazine Small molecule Intravenous
Comparator Doxorubicin Other / unclassified Intravenous
Comparator Vinblastine Small molecule Intravenous

Indications