Spots Global Cancer Trial Database for CIK-Cells in Relapsing Patients With Acute Leukemia or Myelodysplastic Syndromes After SCT.
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Trial Identification
Brief Title: CIK-Cells in Relapsing Patients With Acute Leukemia or Myelodysplastic Syndromes After SCT.
Official Title: A Prospective Phase I/II Study to Investigate the Feasibility, Safety and Efficacy of IL-15 Activated Cytokine Induced Killer (CIK) Cells in Relapsing Patients With Acute Leukemia or Myelodysplastic Syndromes After Allogeneic SCT
Study ID: NCT02752243
Interventions
Study Description
Brief Summary: Multi-site, non-randomized Phase I/II study involving children and adults.
Detailed Description: 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.
Eligibility
Minimum Age: 0 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University Hospital Heidelberg, Ruprecht Karls University, Hospital for children and adolescents, Pediatrics III, Department of Oncology, Haematology, Immunology and Pneumology, Heidelberg, Baden-Württemberg, Germany
Division for Stem Cell Transplantation and Immunology, Department for Children and Adolescents, University Hospital Frankfurt, Frankfurt / Main, Hessen, Germany
Internal Medicine II, Department of Hematology, Oncology, Rheumatology and Infectious Diseases, Goethe-University Frankfurt/Main, Frankfurt / Main, Hessen, Germany
University Medicine Duesseldorf, Department of Paediatric Oncology, Haematology and Immunology, Bone Marrow Transplantation Unit, Duesseldorf, North Rhine-Westphalia, Germany
Internal Medicine III, Department of Hematology and Oncology, Johannes Gutenberg University, Mainz, Rhineland Palatinate, Germany
Contact Details
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