Clinical Trial: Safety of Lenalidomide and Markers for Disease Progression in Patients With International Prognostic Scoring System (IPSS) Low- or Intermediate-1 Risk Myelodysplastic Syndromes (MDS) With Isolated del5q

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Multicenter, Single-arm, Open-label Phase II Study of the Safety of Lenalidomide Monotherapy and Markers for Disease Progression in Patients With IPSS Low- or Intermediate-1 Risk Myelodysplastic Syn

Brief Summary: The purpose of this study is to determine the safety of lenalidomide and markers for disease progression in the treatment of IPSS low- or intermediate-1 risk MDS with isolated del5q.

Detailed Summary: Lenalidomide has been successfully used in patients with MDS in several studies. A small proportion of patients with MDS and del(5q) developed leukemia while treated with Lenalidomide. Up to now it is unknown what patients are at risk to progress while being treated with Lenalidomid. Therefore it is planned to examine not only the traditional clinical parameters like disease status and proportion of blasts, but also cytogenetic findings, gene expression, antiangiogenic effect, marrow fibrosis, mesenchymal stem cell as well as mitochondrial DNA mutation at baseline and in the course of the study performed by central laboratories. Moreover, long-term data are required, e.g., with regard to the development of AML. Therefore, it is planned to collect data from all patients with MDS and del 5q (isolated, blast count <5%) in whom treatment with lenalidomide is the best therapeutic option according to the investigator's assessment in a structured fashion.
Sponsor: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH

Current Primary Outcome: To identify predictive factors for disease progression in patients with MDS and an isolated deletion del(5q), blast count <5%, undergoing treatment with lenalidomide [ Time Frame: maximum 4 years ]

Original Primary Outcome: To identify predictive factors for disease progression in patients with MDS and an isolated deletion del(5q), blast count <5%, undergoing treatment with lenalidomide [ Time Frame: 2 years ]

Current Secondary Outcome:

  • Transfusion Independency on 56 consecutive days after enrollment [ Time Frame: maximum 4 years ]
  • Cytologic Review [ Time Frame: maximum 4 years ]
    Investigation of bone marrow to identify blasts, ringed sideroblasts and dysplastic changes


Original Secondary Outcome:

  • Transfusion Independency on 56 consecutive days after enrollment [ Time Frame: 2 years ]
  • Cytologic Review [ Time Frame: 2 years ]
    Investigation of bone marrow to identify blasts, ringed sideroblasts and dysplastic changes


Information By: Gesellschaft fur Medizinische Innovation – Hamatologie und Onkologie mbH

Dates:
Date Received: March 2, 2010
Date Started: March 2010
Date Completion:
Last Updated: March 11, 2013
Last Verified: March 2013