B-cell Lymphoma Refractory
Conditions
Keywords
B-cell Non Hodgkin's Lymphomas, CD22 positive
Brief 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.
Interventions
DRUGInotuzumab Ozogamicin
starting dose 0.8 mg/m2, d1 administration, q4wks
DRUGTemsirolimus
starting dose of 15mg, weekly administration, q4ws
Sponsors
Cristiana Sessa
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Key inclusion criteria * Histologically and/or cytologically confirmed relapsed or refractory CD22+ B-cell Non Hodgkin's Lymphomas * No limitations on prior treatments. Patients must have progressed after at least one prior therapy. * Adult patients (aged \> 18yrs old). * ECOG status ≤ 1. * Life expectancy greater than 3 months. * Adequate organ and marrow function. Key
Exclusion criteria
* Uncontrolled intercurrent illness * Chronic obstructive or chronic restrictive pulmonary disease * Hepatitis B, C and HIV * Patients with known known central nervous system lymphoma involvement.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with adverse events based on the CTCAE v.4 | toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Antitumor activity based on Cheson criteria | after 12-18 months form the first patient in |
Countries
Switzerland
Outcome results
None listed