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New stem cell research, transplant strategies show promise to improve outcomes, reduce complications
Date:12/9/2012

n Arbor, Mich. and Washington University in St. Louis to compare results of a standard regimen with vorinostat to historical controls. The primary endpoint of the single-arm, Phase I/II trial was the cumulative incidence of grade 2-4 acute GHVD (grade 1 is mildest; grade 4 is most severe). They aimed for an incidence of no more than 25 percent, compared with historical average rates of 42 percent.

Patients participating in the study received oral vorinostat daily in addition to standard preventive treatments prior to, during, and for 100 days after transplantation. After treatment, these patients had a significantly lower incidence of GVHD than their historical controls (22 % vs. 42%) and had lower rates of severe (grade 3-4) GVHD (4% vs. 19% in controls) and transplant-related mortality at one year (13% vs. 19% in controls). There were no differences in rates of infectious complications or incidence of relapse, indicating that vorinostat helped reduce the risk of GVHD in patients without further compromising their immune systems.

"While GVHD remains a challenging complication that affects a large proportion of patients who receive stem cell transplants, we are encouraged by the significant reduction in both the incidence and severity of this life-threatening condition that we observed in this trial," said Pavan Reddy, MD, senior author and Co-Director of the University of Michigan Bone Marrow Transplant and Hematologic Malignancies Program. "In order to increase the use of transplants and make them safer for more patients who need them, we need to see if this treatment approach may be successful in patients who receive stem cells from unrelated donors, and whether it may work among patients who are at high risk for severe GVHD. Moreover, we would like to confirm our findings in a larger, Phase III clinical trial."

Sung W. Choi, MD, lead author, will present this study in an oral presentation on Monday, December 10, at 4:45 p.m. EST a
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Contact: Andrea Slesinski
aslesinski@hematology.org
614-352-5096
American Society of Hematology
Source:Eurekalert

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