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Spots Global Cancer Trial Database for Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma

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Trial Identification

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

Official Title: 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

Study ID: NCT01195766

Conditions

Hodgkin Disease

Interventions

Ofatumumab

Study Description

Brief 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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

Instituto Catalan de Oncologia, L'Hospitalet, Barcelona, Spain

Hospital Son Espases, Palma de Mallorca, Mallorca, Spain

Hospital de Navarra, Pamplona, Navarra, Spain

Hospital Sant Pau, Barcelona, , Spain

Hospital Clinic, Barcelona, , Spain

Hospital Clinico San Carlos, Madrid, , Spain

Hospital Ramon y Cajal, Madrid, , Spain

Hospital Carlos Haya, Malaga, , Spain

Hospital Morales Messeguer, Murcia, , Spain

Hospital Clinico de Salamanca, Salamanca, , Spain

Hospital Universitario de Canarias, Tenerife, , Spain

Hospital Clinico de Valencia, Valencia, , Spain

Hospital Rio Hortega, Valladolid, , Spain

Contact Details

Name: Carmen Martínez, MD

Affiliation: Hospital Clinic i provincial de Barcelona

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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