Multi-site, non-randomized Phase I/II study involving children and adults.
This is a phase I/II multicenter-study to investigate the feasibility safety and efficacy of interleukin (IL)-15 activated CIK cells in patients with acute leukemia or myelodysplastic syndrome (MDS) showing evidence of relapse after allogeneic stem cell transplantation (SCT). CIK cell infusions will be given with an interval of 4-6 weeks according to a dose escalation schedule in patients with impending relapse after allogeneic SCT. In presence of acute graft versus host disease (aGvHD) ≥ grade II, the next scheduled infusion will not be administered.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
32
IL-15 activated CIK cells individually generated from PB mononuclear cells of the original stem cell donors.
University Hospital Heidelberg, Ruprecht Karls University, Hospital for children and adolescents, Pediatrics III, Department of Oncology, Haematology, Immunology and Pneumology
Heidelberg, Baden-Wurttemberg, Germany
Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt
Frankfurt am Main, Hesse, Germany
Internal Medicine II, Department of Hematology, Oncology, Rheumatology and Infectious Diseases, Goethe-University Frankfurt/Main
Frankfurt am Main, Hesse, Germany
The occurrence of grade three or four acute Graft versus Host Disease (aGvHD)
Time frame: two until four weeks after CIK-Cell Infusion
Extensive chronic Graft versus Host Disease (cGvHD)
Time frame: two until four weeks after CIK-Cell Infusion
Efficacy of CIK-Cells analyzed by progression free survival
Time frame: one year
Overall survival
Time frame: one year
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University Medicine Duesseldorf, Department of Paediatric Oncology, Haematology and Immunology, Bone Marrow Transplantation Unit
Düsseldorf, North Rhine-Westphalia, Germany
Internal Medicine III, Department of Hematology and Oncology, Johannes Gutenberg University
Mainz, Rhineland-Palatinate, Germany