Spots Global Cancer Trial Database for Safety Study of 5-Azacitidine and Standard Donor Lymphocyte Infusion (DLI) to Treat Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing After Allogeneic Stem Cell Transplantation
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Trial Identification
Brief Title: Safety Study of 5-Azacitidine and Standard Donor Lymphocyte Infusion (DLI) to Treat Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS) Relapsing After Allogeneic Stem Cell Transplantation
Official Title: Phase-II Trial to Assess the Efficacy and Toxicity of 5-Azacitidine in Addition to Standard DLI for the Treatment of Patients With AML or MDS Relapsing After Allogeneic Stem Cell Transplantation
Study ID: NCT00795548
Interventions
Study Description
Brief Summary: This open label phase-II trial evaluates hematological response of an additional treatment with 5-Azacitidine to common DLI in patients with MDS or AML relapsing after allogeneic stem cell transplantation.
Detailed Description: Relapse after allogeneic stem cell transplantation is a major problem in patients with poor prognosis AML or MDS. Donor lymphocyte infusions alone re-induce remission in a minority of these patients, which may be the result of poor differentiation of the leukemic cells. The study drug 5-Aza is effective in AML and MDS.In addition to direct cytotoxicity, it alters gene expression and induces differentiation of leukemic blast cells. Furthermore, DNA-demethylating treatment results in an induction of transcription and cell surface expression of formerly unexpressed KIRs (killer Ig-like receptors) in NK cells, which are involved in the specific recognition of leukemic target cells and who are able to generate a specific graft-versus leukemia effect. The increased expression of MHC class I and II molecules on the surface of the recipient's leukemic cells and the de novo expression of formerly silenced KIR genes in donor NK cells due to treatment with 5-Aza may result in an increased susceptibility of myeloid leukemic cells to the allogeneic graft versus leukemia effect. Therefore, the graft-versus leukemia effect by donor lymphocyte infusions and NK cells from the original donor may be supported by additional therapy with 5-Azacitidine.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Universitaetsklinik Heidelberg, Medizinische Klinik und Poliklinik V, Heidelberg, Baden-Wuertemberg, Germany
Klinikum der Johann-Wolfgang-Goethe Universität, Medizinische Klinik II, Frankfurt, Hessen, Germany
Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf, Duesseldorf, NW, Germany
Universitaetsklinikum Dresden, Medizinische Klinik und Poliklinik I, Dresden, Sachsen, Germany
Charite´-Campus Benjamin Franklin, Medizinische Klinik III, Berlin, , Germany
Bone Marrow Transplantation Unit, University Hospital Hamburg-Eppendorf, Hamburg, , Germany
Contact Details
Name: Guido Kobbe, PD Dr.
Affiliation: Department of Hematology, Oncology and Clinical Immunology
Role: PRINCIPAL_INVESTIGATOR
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