pancreatic cancer MedDRA version: 17.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864
Conditions
Interventions
Product Name: Allogeneic hematopoietic stem cells
Pharmaceutical Form: Suspension for injection
Sponsors
Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically proven diagnosis of pancreatic ductal adenocarcinoma having undergone radical resection (R1/R0 local resection) within the last 4-6 months• Hartwig score 1 or 2 (Millenium paper 1) • Measurable tumor serum marker (i.e. CA 19-9) prior to resection • Age at registration 18 to 65 years • Karnofsky index > /=70 • Hematopoietic cell transplantation comorbidity index (HCT-CI) score 0-1 (pancreatic carcinoma does not count against the score) • HLA-identical (10/10 intermediate-resolution) related donor • Written informed consent, signed and dated Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 12 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Hartwig score = 0 (Millenium paper 1) • HIV, HBV, HCV seropositivity • Organ dysfunction - Symptomatic coronary artery disease or ejection fraction 1.5 X ULN, or AST/ALT >2.5XULN - Chronic renal dysfunction defined by a creatinine clearance <50 ml/min. • Fertile men and women unwilling to use contraceptive techniques during and for 12 months following treatment • Females who are pregnant or breastfeeding • Active other malignancies and/or a history of another malignancy treated by chemotherapy or radiotherapy within the last five years prior to inclusion • Patients with systemic, uncontrolled infections • current alcohol or drug abuse • Previously known contraindication and/or intolerance against study-related substances including medication for immunosuppression • inability to understand the scope of the study and intent of treatment. Dementia or altered mental status that would prohibit understanding informed consent • participation in another interventional clinical trial according to the Arzneimittelgesetz within 30 days prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall objective of this trial is to generate for the first time state-of-the-art scientific clinical evidence that allo-HSCT is feasible and can provide long-term disease control in patients with effectively resected pancreatic adenocarcinoma and may have the potential to change the natural course of this otherwise fatal malignancy.;Secondary Objective: n.a.;Primary end point(s): 2-year progression-free survival (PFS) from registration.;Timepoint(s) of evaluation of this end point: after 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2-year PFS and overall survival (OS) after surgical resection; 2-year overall survival (OS) from registration; Minimal residual disease kinetics at S, R, 1, 3, 6, 12, 18 and 24 months according to study protocol (MRD; measured by tumor serum marker levels) and their correlation with immune events; impact of important explanatory variables on PFS and OS.;Timepoint(s) of evaluation of this end point: after 2 years | — |
Countries
Germany
Contacts
Public ContactClinic of General Surgery
University Hospital Heidelberg
Outcome results
None listed