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

Blood Transfusion Centre of Slovenia

Status and phase: Unknown; Phase 2

Conditions: Pancreatic Tubular Adenocarcinoma

Treatments: Biological: MIS

Study type: Interventional

Funder types: Other

Identifiers

NCT01021800

MIS

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Cell infusion

Experimental group

Treatment:

Biological: MIS