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Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma (SYSTHER)

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ClinicalTrials.gov Identifier: NCT01021800
Recruitment Status : Unknown
Verified November 2009 by Blood Transfusion Centre of Slovenia.
Recruitment status was:  Recruiting
First Posted : November 30, 2009
Last Update Posted : January 13, 2010
Sponsor:
Information provided by:

November 27, 2009
November 30, 2009
January 13, 2010
April 2009
December 2011   (Final data collection date for primary outcome measure)
PROGRESSION FREE SURVIVAL [ Time Frame: 1 YEAR ]
Not Provided
Complete list of historical versions of study NCT01021800 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Modulation of the Immune Response in Patients With Pancreatic Tubular Adenocarcinoma
Not Provided
Interventional study of modulation of immune response in patients with pancreatic tubular adenocarcinoma after resection and gemcitabine treatment. When included, patients are pre-treated with moderate doses of cyclophosphamide. Then infusions of allogeneic mononuclear cells are given.
Not Provided
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Pancreatic Tubular Adenocarcinoma
Biological: MIS
Cell infusion
Experimental: Cell infusion
Intervention: Biological: MIS
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
30
December 2012
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • ECOG performance status 0-2 at the time of inclusion
  • Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment

Exclusion Criteria:

  • Pregnancy
  • Less than 3 mths expected survival
  • Serious comorbidity
  • Age above 70 yrs
Sexes Eligible for Study: All
30 Years to 70 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Slovenia
 
 
NCT01021800
MIS
Yes
Not Provided
Not Provided
Primoz Rozman, MD PhD, Blood Transfusion Centre of Slovenia
Blood Transfusion Centre of Slovenia
Not Provided
Not Provided
Blood Transfusion Centre of Slovenia
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP