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
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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Analysis of the global response rate (complete responses + partial responses) after O-ESHAP treatment
4 years follow-up
Yes
Spain: Spanish Agency of Medicines
O-ESHAP-LH-2009
NCT01195766
July 2010
May 2014
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