NCT01021800

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2009

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 30, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

January 13, 2010

Status Verified

November 1, 2009

Enrollment Period

2.7 years

First QC Date

November 27, 2009

Last Update Submit

January 12, 2010

Conditions

Pancreatic Tubular Adenocarcinoma

Keywords

Pancreatic tubular adenocarcinoma adjuvant setting

Outcome Measures

Primary Outcomes (1)

  • PROGRESSION FREE SURVIVAL

    1 YEAR

Study Arms (1)

Cell infusion

EXPERIMENTAL
Biological: MIS

Interventions

MISBIOLOGICAL

Cell infusion

Cell infusion

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Following R0 or R1 pancreatic tubular adenocarcinoma resection and adjuvant gemcitabine treatment

You may not qualify if:

  • Pregnancy
  • Less than 3 mths expected survival
  • Serious comorbidity
  • Age above 70 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Ljubljana, Department for Gastroenterolgy

Ljubljana, Ljubljana, 1000, Slovenia

RECRUITING

Central Study Contacts

Borut Stabuc, MD PhD

CONTACT

+38615222210borut.stabuc@kclj.si

Lojze Smid, MD

CONTACT

lojze.smid.jr@mf.uni-lj.si

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

November 27, 2009

First Posted

November 30, 2009

Study Start

April 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

January 13, 2010

Record last verified: 2009-11

Locations

SL(1)