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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Blood Transfusion Centre of Slovenia.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Blood Transfusion Centre of Slovenia
ClinicalTrials.gov Identifier:
NCT01021800
First received: November 27, 2009
Last updated: January 12, 2010
Last verified: November 2009

November 27, 2009
January 12, 2010
April 2009
December 2011   (final data collection date for primary outcome measure)
PROGRESSION FREE SURVIVAL [ Time Frame: 1 YEAR ] [ Designated as safety issue: No ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Recruiting
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
Both
30 Years to 70 Years
No
Contact: Borut Stabuc, MD PhD +38615222210 borut.stabuc@kclj.si
Contact: Lojze Smid, MD lojze.smid.jr@mf.uni-lj.si
Slovenia
 
NCT01021800
MIS
Yes
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