Lenalidomide Clinical Trial
I was offered the opportunity to participate in a Phase I clinical trial today. The consent form states:
The purpose of this research study is to evaluate the safety and maximum tolerated dose of a drug called lenalidomide in patients with acute myelogenous leukemia (AML) and myelodysplastic syndrome (MDS), with minimal residual disease (MRD) following allogeneic hematopoietic stem cell transplant (allo-HSCT). This study will look at: any side effects that occur, the effectiveness of the study drug, and how your disease reacts to lenalidomide. This study will try to find the highest tolerated dose of this drug without causing serious side effects. This study will also look to see how your cancer responds to the drug using laboratory tests. Allogeneic HSCT is an effective treatment for high risk AML and MDS, however relapse following transplant continues to be a major obstacle to treatment success and cure. Treatment of relapsed disease is more successful if started earlier when disease levels are lower. This study will use a laboratory test called CD34+ donor chimerism to detect MRD following your allogeneic HSCT. MRD is the name given to small numbers of leukemic cells that remain in your body during and after treatment, even when you are considered to be disease free. The CD34+ donor chimerism test may be able to detect relapsed disease earlier than traditional methods and allow us to treat you sooner.
Has anyone heard of using lenalidomide in this manner? I believe this particular trial is only being conducted at UF Health, Gainesville, FL. My dose would be 2.5 mg once daily orally on Days 1-21 of repeated 28-day cycles ( the study would only consist of two cycles). One aspect of the trail that intrigued me was the CD34+ donor chimerism because it might give me a better indication of my chances of relapsing.
Any comments are greatly appreciated!!
Prostate Cancer: Treated in early 2013 with HDR Brachytherapy. MDS-RCMD: Oct 2014. Biopsies: 46,XY,t(7;18): 46,XY,del(7)( q22): 45,XY,-7: 45,XY,-7: 45,XY,-7. HSCT in April 2016.
Last edited by Data : Mon Jun 20, 2016 at 03:07 PM.
Reason: 2.5 mg vice 25 mg