Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
Summary
This is an open label phase I study of Inotuzumab Ozogamicin, an antibody-targeted
intravenous chemotherapy agent composed of a CD22-targeted antibody linked to calicheamicin,
in combination with the mammalian target of rapamycin (mTOR) inhibitor Temsirolimus, in
patients with relapsed/refractory CD22+ B-cell non Hodgkin's lymphomas (NHLs). Both
Inotuzumab Ozogamicin and Temsirolimus have been evaluated as single agents as well as in
combination with rituximab in patients with NHLs. This is the first study combining the two
agents together. In the present study Inotuzumab Ozogamicin will be administered
intravenously on d1 at the starting dose of 0.8 /m2. Temsirolimus will be administered
intravenously on days 1,8,15 and 22 at the starting dose of 15mg. Cycles will be repeated
every 28 days.