A Dose Range Finding Study of Lenalidomide in Non-5q Chromosome Deletion in Low and Intermediate Risk Myelodysplastic Syndrome (MDS) Patients
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|ClinicalTrials.gov Identifier: NCT00699842|
Recruitment Status : Terminated (Administratively terminated per FDA recommendation)
First Posted : June 18, 2008
Results First Posted : June 3, 2014
Last Update Posted : November 29, 2016
|Condition or disease||Intervention/treatment||Phase|
|Myelodysplastic Syndrome MDS Low to Intermediate-1 MDS Non-deletion 5q||Drug: Lenalidomide||Phase 1 Phase 2|
There are little options for non deletion 5q Low and INT-1 patients. This study aims to find an early clinical signal for higher activity and better response with lenalidomide in patients with non deletion 5q Low and INT-1 MDS patients. Lenalidomide is an immunomodulatory agent. Thalidomide, the parent compound, has both immunomodulatory and anti-angiogenic properties which could confer anti-tumor and anti-metastatic efforts. Lenalidomide has been demonstrated to possess anti-angiogenic activity through inhibition of basic fibroblast growth factor (bFGF), vascular endothelial growth factor (VEGF) and tumor necrosis factor-alpha (TNF-alpha) induced endothelial cell migration (movement of cells in preparation to form new abnormal blood vessels for cancer cells), due at least in part to inhibition of Akt phosphorylation response to bFGF.
In addition, lenalidomide has a variety of immunomodulatory effects. Lenalidomide stimulates T cell proliferation, and the production of interleukin-2 (IL-2), IL-10 and interferon-gamma (IFN-gamma), inhibits IL-1 beta and IL-6 and modulated IL-12 production.
Although the exact anti-tumor mechanism of action of lenalidomide is unknown, a number of mechanisms are postulated for the activity of Lenalidomide in MDS.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Optimal Dose Study of Lenalidomide in the Non-5q- LOW and INT-1 Risk MDS Patients|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||January 2011|
|Actual Study Completion Date :||May 2012|
Lenalidomide will be given orally on day 1-21, followed by a 7day rest (28 day cycle). Cycles will be repeated every 28 days.
Dose Level Lenalidomide Schedule
Other Name: Revlimid
- Determine CR, PR, and Rate of Stable Disease in MDS Patients [ Time Frame: 2 years ]Determine CR, PR, and rate of stable disease in MDS patients, IPSS Score LOW or INT-1 who do not have the 5q- cytogenetic abnormality according to the IWG criteria for response in >10mg doses of lenalidomide
- Safety With Dose Escalation [ Time Frame: 2 years ]Safety (type, frequency, severity, and relationship of adverse events to study treatment) with dose escalation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00699842
|United States, Pennsylvania|
|Associates in Hematology-Oncology, PC|
|Chester, Pennsylvania, United States, 19130|
|Thomas Jefferson University|
|Philadelphia, Pennsylvania, United States, 19107|
|Principal Investigator:||Emmanuel Besa, MD||Thomas Jefferson University|