Ignite Creation Date:
2025-12-24 @ 4:11 PM
Ignite Modification Date:
2025-12-28 @ 3:58 PM
Study NCT ID:
NCT01195766
Status:
COMPLETED
Last Update Posted:
2016-02-24
First Post:
2010-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Ofatumumab and ESHAP for the Treatment of Hodgkin's Lymphoma
Sponsor:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2016-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2009-016026-13 | EUDRACT_NUMBER | None | View |