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

No results posted yet for this study

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

Interventions

DRUG

lenalidomide

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00720850 on ClinicalTrials.gov