Spots Global Cancer Trial Database for Lenalidomide Maintenance Therapy in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
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Trial Identification
Brief Title: Lenalidomide Maintenance Therapy in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
Official Title: Lenalidomide Maintenance Therapy in Patients With MDS or AML With Cytogenetic Abnormalities Involving Monosomy 5 or del5q After Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
Study ID: NCT00720850
Interventions
Study Description
Brief Summary: The hypothesis of this study is that lenalidomide can be an effective drug in preventing relapse of MDS and AML patients with chromosomal abnormalities involving monosomy 5 or del5q after allogeneic HSCT. Due to its immunomodulatory action it might also be able to enhance a T - or NK cell mediated graft versus leukemia (GVL) effects. Nevertheless, one has to keep in mind a possible, yet unknown influence on modulation of clinical GVHD.
Detailed Description: Cytogenetics are main predictors of outcome in patients with MDS and AML. In fact, a monosomy 5 (-5) or del5q (excluding typical 5q-syndrome) are mostly poor prognostic markers also because being frequently part of a complex karyotype. Together, these patients often do not respond to conventional chemotherapy and can only be cured by allogeneic HSCT. Nevertheless, even after transplantation the relapse rate is considerably high and in the majority of patient's relapses occur within the first year after HSCT. Lenalidomide has been successfully used in MDS patients with del5q, irrespective of additional cytogenetic abnormalities. Furthermore, in vitro studies have demonstrated also impressive anti-proliferative effects of the compound in cell lines harbouring a monosomy 5. Therefore, it seems to be a promising compound in preventing relapse of high-risk MDS or AML patients with chromosomal abnormalities involving del5q or -5 after allogeneic HSCT. Due to its immunomodulatory action it might also be able to enhance T - or NK cell mediated graft versus leukemia effects. Nevertheless, it is unknown whether lenalidomide could modulate or enhance clinical graft versus host disease.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Dresden University of Technology, Medizinische Klinik und Poliklinik 1, Dresden, Saxony, Germany
Universitätsklinikum Dßsseldorf, Medizinische Klinik und Poliklinik, Klinik fßr Hämatologie, Onkologie und klinische Immunologie, Dßsseldorf, , Germany
Universitätsklinikum Essen, Klinik fßr Knochenmarktransplantation, Essen, , Germany
Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum, Hamburg, , Germany
Medizinische Hochschule Hannover, Zentrum Innere Medizin, Hämatologie, Hannover, , Germany
Universitätsklinikum Ulm, Klinik fßr Innere Medizin III, Ulm, , Germany
Universitätsklinikum Wßrzburg, Medizinische Klinik und Poliklinik II, Wßrzburg, , Germany
Contact Details
Name: Uwe Platzbecker, PD Dr. med.
Affiliation: Dresden University of Technology, Medizinische Klinik und Poliklinik 1
Role: STUDY_CHAIR
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