Lenalidomide Maintenance Therapy in Patients With Myelodysplastic Syndromes (MDS) or Acute Myelogenous Leukemia (AML)
NCT00720850 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2013-09-27
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.
Conditions
- Myelodysplastic Syndromes
- Acute Myelogenous Leukemia
Interventions
- DRUG
-
p.o. 10 mg/d for 21 days every 4 weeks for 1 year (12 cycles) after HSCT
Sponsors & Collaborators
-
Celgene Corporation
collaborator INDUSTRY -
Technische Universität Dresden
lead OTHER
Principal Investigators
-
Uwe Platzbecker, PD Dr. med. · Dresden University of Technology, Medizinische Klinik und Poliklinik 1
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2011-01-31
- Completion
- 2011-01-31
Countries
- Germany
Study Locations
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