drugset / Trial / NCT00816959
Study Evaluating the Effect of R-mabHDI in Lymphocytic Predominant Hodgkin's Lymphoma
Phase 3
Unknown
1200 enrolled
American Scitech International
Bristol-Myers Squibb · collabEli Lilly and Company · collab
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | R-mabHDI | Unknown | — | Intravenous |
| Comparator | Bleomycin | Unknown | — | Intravenous |
| Comparator | Dacarbazine | Small molecule | — | Intravenous |
| Comparator | Doxorubicin | Other / unclassified | — | Intravenous |
| Comparator | Vinblastine | Small molecule | — | Intravenous |