Clinical Trial for Untreated MDS
This study is being conducted in two stages (phases). During Phase I of the trial, multiple dose levels of vadastuximab talirine (SGN-CD33A) in combination with azacitidine will be prescribed to treat subjects with previously untreated intermediate or high risk MDS. The Phase I stage of the study is to determine the best dose of vadastuximab talirine to use with azacitidine when treating subjects with MDS.
In Phase II of this study, subjects will be assigned randomly to one of two treatment arms: azacitidine plus vadastuximab talirine or azacitidine plus placebo. The assigned arm will be double-blinded (the study doctor nor the participating subject will know whether the subject is getting vadastuximab talirine or placebo along with azacitidine). This part of the study is designed to compare the overall response rate of MDS to vadastuximab talirine added to azacitidine versus receiving azacitidine alone.
Study treatment consists of repeated 4-week cycles of combination treatment. Subjects may continue to receive treatment until they experience disease progression, relapse, or unacceptable side effects. All subjects will be contacted for survival status every 2 months after an end of treatment visit until death or the study closure, whichever comes first.
In order to participate you must meet the following criteria:
- Have cytologically/histologically confirmed intermediate-2 or high risk MDS with greater than or equal to 5% and less than 20% bone marrow blasts.
- Be previously untreated for MDS with the exception of transfusions, hematopoietic growth factors, or immunosuppressive therapy.
- Be 18 years old or older.
- Be eligible for therapy with azacitidine.
- Have a life expectancy of at least 12 weeks.
You will be excluded from the study if any of the following criteria apply to you:
- Have received lenalidomide or hypomethylating agents as prior treatment for MDS.
- Have a history of one of the following myeloproliferative neoplasms: Essential thrombocythemia, polycythemia vera, or primary myelofibrosis.
- Have a second malignancy currently requiring active therapy (except for hormonal/anti-hormonal treatment for prostate or breast cancer).
- Are positive for HIV, hepatitis B or active hepatitis C.
This is a partial list of inclusion and exclusion criteria.