stem cell transplantation in pancreatic cancer after surgical resectio
- Conditions
- pancreatic cancerMedDRA version: 17.0 Level: LLT Classification code 10033604 Term: Pancreatic cancer System Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-003528-19-DE
- Lead Sponsor
- Ruprecht-Karls-University Heidelberg, Medical Faculty represented by Universitätsklinikum Heidelberg and its Commercial
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 12
•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
•Hartwig score = 0 (Millenium paper 1)
•HIV, HBV, HCV seropositivity
•Organ dysfunction
-Symptomatic coronary artery disease or ejection fraction <35%
-DLCO =60%, FEV1 <65% of predicted FEV1 despite appropriate treatment or receiving supplementary continuous oxygen
-Liver function abnormalities: Patients with will be excluded if total serum bilirubin >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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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