NCT02207985

Brief Summary

Aim: To study the antitumour effect of reduced intensity conditioning (RIC) with allogeneic stem cell transplantation (HSCT) in patients with pancreatic adenocarcinoma after radical resection of the tumour and adjuvant treatment with standard chemotherapy. Importance: If investigators can accomplish an anti-tumour effect using RIC with HSCT as adjuvant treatment in patients with pancreatic adenocarcinoma, it might increase the survival or even cure patients in this group with very poor prognosis. Primary scientific question: Can investigators demonstrate an anti-tumour effect against pancreatic adenocarcinoma using adjuvant treatment with HSCT? Can investigators demonstrate an anti-tumour effect against pancreatic adenocarcinoma using adjuvant treatment with HSCT?

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
7.5 years until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 4, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

10.4 years

First QC Date

June 18, 2014

Last Update Submit

July 4, 2023

Conditions

Pancreatic Adenocarcinoma

Keywords

Pancreatic adenocarcinomaHematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (1)

  • disease free survival

    Five years

Study Arms (1)

Hematopoetic stem cell transplantation

EXPERIMENTAL

Patients with pancreatic adenocarcinoma that have undergone Whipple surgery and show no sign of disease recurrence can be treated with hematopoietic stem cell transplantation to achieve an immunological anti-tumor effect.

Procedure: Allogeneic hematopoietic stem cell transplantation

Interventions

Allogeneic hematopoietic stem cell transplantationPROCEDURE
Hematopoetic stem cell transplantation

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with pancreatic adenocarcinoma who have undergone curative surgery ad modum Whipple with radical resection of the tumor, R0 or R1.

You may not qualify if:

  • Pancreatic adenocarcinoma with metastasis or non-radical resection.
  • Recurrence of the malignancy after curative surgery and adjuvant chemotherapy.
  • Age above 70 years.
  • Severe heart disease, liver disease, impaired renal function or other organ failure or underlying diseases that would exclude the patient from undergoing hematopoietic stem cell transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for allogeneic stem cell transplantation, Karolinska University hospital

Stockholm, 141 86, Sweden

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D, PhD

Study Record Dates

First Submitted

June 18, 2014

First Posted

August 4, 2014

Study Start

January 1, 2007

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

SE(1)