NCT01195766

Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma

Phase II-study Using Ofatumumab and ESHAP Followed by Autologous Trasplant of Hemopoietic Precursors for the Treatment of Classic Hodgkin's Lymphoma on Relapse, Partial Response or Refractory to First Line Treatment

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to analyze the efficacy of O-ESHAP treatment for Hodgkin's lymphome patients that have a first line chemotherapy treatment failure due to refractoriness, partial response or relapsed. In the same way, mortality, global survival and free-progression survival after O-ESHAP treatment and TAPH will also analyzed.

Detailed description

In addition to the above: * To asses the complete response rate after O-ESHAP. * To asses the toxicity of O-ESHAP regimen * To asses the stem cells mobilization capacity of O-ESHAP regimen * To evaluate the final results of the whole procedure (O-ESHAP followed by high-dose chemotherapy and ASCT): transplant-related mortality (TRM), overall survival (OS), and progression free survival (PFS) * To investigate the correlation between the overall response and CD20 expression by tumoral cells.

Conditions

• Hodgkin Disease

Interventions

Type	Name	Description
DRUG	Ofatumumab	Ofatumumab in addition with ESHAP therapy

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-09-01
• Completion: 2015-05-01
• First posted: 2010-09-06
• Last updated: 2016-02-24

Locations

14 sites across 1 country: Spain