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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
25
starting dose 0.8 mg/m2, d1 administration, q4wks
starting dose of 15mg, weekly administration, q4ws
InselSpital, Universitätsspital Bern
Bern, Canton of Bern, Switzerland
Oncology Institute of Southern Switzerland
Bellinzona, Canton Ticino, Switzerland
Kantonsspital St.Gallen
San Gallen, San Gallen, Switzerland
number of participants with adverse events based on the CTCAE v.4
To determine the safety profile, establish the maximum tolerated dose (MTD) and recommended phase II dose (RP2D) of Inotuzumab Ozogamicin in combination with Temsirolimus in patients with relapsed/refractory CD22+ B-cell NHLs
Time frame: toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks
Antitumor activity based on Cheson criteria
Time frame: after 12-18 months form the first patient in
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