Status:
COMPLETED
Cytokine Induced Killer (CIK) Cells In Leukemia Patients
Lead Sponsor:
A.O. Ospedale Papa Giovanni XXIII
Collaborating Sponsors:
Regional Hospital of Bolzano
Azienda Ospedaliera San Gerardo di Monza
Conditions:
Hematologic Malignancies
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The purpose of the Phase IIA study are to: 1. define the safety profile 2. evaluate the efficacy of a sequential infusion of unmanipulated Donor Lymphocyte Infusions (DLI) and Cytokine Induced Killer...
Detailed Description
This study is an open-label, multicenter, exploratory phase IIA study to evaluate the safety (dose-finding) and efficacy of a sequential administration of donor derived unmanipulated DLI and in vitro ...
Eligibility Criteria
Inclusion
- Patients with haematologic malignancies (excluding chronic myeloid Leukemia- CML) with a molecular, cytogenetic or haematologic relapse after allogeneic transplantation.
- Patients with an available donor willing to donate peripheral blood lymphocytes
- Immunosuppression must be withdrawn at the beginning of the cell therapy program
- Written informed consent prior to any study procedures being performed
Exclusion
- Donors positive for HIV, HBV or HCV, or unfit to undergo leukapheresis
- Patients with active acute or chronic Graft versus host disease (GvHD)
- Patients with rapidly progressive disease or not controlled by palliative supportive treatments including chemotherapy and with a life expectancy less than 8 weeks
- Patients with severe psychiatric illness or any disorder that compromises ability to give truly informed consent for participation in this study
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2017
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT01186809
Start Date
July 1 2009
End Date
May 15 2017
Last Update
January 23 2019
Active Locations (3)
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1
Azienda Ospedaliera Papa Giovanni XXIII (Former:Ospedali Riuniti di Bergamo) Bergamo
Bergamo, Italy, 24127
2
Ospedale Centrale di Bolzano
Bolzano, Italy
3
Ospedale San Gerardo
Monza, Italy