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Sponsors and Collaborators: |
Dresden University of Technology Celgene Corporation |
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Information provided by: | Dresden University of Technology |
ClinicalTrials.gov Identifier: | NCT00720850 |
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.
Condition | Intervention | Phase |
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Myelodysplastic Syndromes Acute Myelogenous Leukemia |
Drug: lenalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
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) |
Estimated Enrollment: | 50 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | September 2011 |
Estimated Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
lenalidomide therapy
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Drug: lenalidomide
p.o. 10 mg/d for 21 days every 4 weeks for 1 year (12 cycles) after HSCT
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory test results within these ranges:
Exclusion Criteria:
Contact: Uwe Platzbecker, PD Dr. med. | +49 (0)351 458-4577 | Uwe.Platzbecker@uniklinikum-dresden.de |
Germany | |
Universitätsklinikum Essen, Klinik für Knochenmarktransplantation | Active, not recruiting |
Essen, Germany, 45122 | |
Universitätsklinikum Ulm, Klinik für Innere Medizin III | Active, not recruiting |
Ulm, Germany, 89081 | |
Universitätsklinikum Würzburg, Medizinische Klinik und Poliklinik II | Not yet recruiting |
Würzburg, Germany, 97080 | |
Contact: H. Einsele, Prof. Dr. +49 (0)931 / 201-70010 Einsele_H@medizin.uni-wuerzburg.de | |
Principal Investigator: H. Einsele, Prof. Dr. | |
Medizinische Hochschule Hannover, Zentrum Innere Medizin, Hämatologie | Active, not recruiting |
Hannover, Germany, 30625 | |
Universitätsklinikum Düsseldorf, Medizinische Klinik und Poliklinik, Klinik für Hämatologie, Onkologie und klinische Immunologie | Active, not recruiting |
Düsseldorf, Germany, 40225 | |
Universitätsklinikum Hamburg-Eppendorf, Onkologisches Zentrum | Active, not recruiting |
Hamburg, Germany, 20246 | |
Germany, Saxony | |
Dresden University of Technology, Medizinische Klinik und Poliklinik 1 | Recruiting |
Dresden, Saxony, Germany, 01307 | |
Contact: Uwe Platzbecker, PD Dr. med. +49 (0)351 458-4577 Uwe.Platzbecker@uniklinikum-dresden.de | |
Principal Investigator: Uwe Platzbecker, PD Dr. med. |
Study Chair: | Uwe Platzbecker, PD Dr. med. | Dresden University of Technology, Medizinische Klinik und Poliklinik 1 |
Responsible Party: | Dresden University of Technology, Medizinische Klinik und Poliklinik 1 ( PD Dr. med. Uwe Platzbecker ) |
Study ID Numbers: | TUD-LENAMA-022 |
Study First Received: | July 17, 2008 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00720850 History of Changes |
Health Authority: | Germany: Ethics Commission; Germany: Federal Institute for Drugs and Medical Devices |
MDS AML Lenalidomide monosomy 5 monosomy del5q |
Monosomy Precancerous Conditions Hematologic Diseases Myelodysplastic Syndromes Lenalidomide Leukemia, Myeloid Leukemia, Myeloid, Acute |
Leukemia Preleukemia Acute Myelocytic Leukemia Acute Myeloid Leukemia, Adult Chromosome Aberrations Congenital Abnormalities Bone Marrow Diseases |
Disease Neoplasms by Histologic Type Precancerous Conditions Antineoplastic Agents Hematologic Diseases Myelodysplastic Syndromes Lenalidomide Leukemia, Myeloid Leukemia, Myeloid, Acute |
Pharmacologic Actions Leukemia Preleukemia Neoplasms Pathologic Processes Therapeutic Uses Syndrome Chromosome Aberrations Bone Marrow Diseases |