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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intravenous | Experimental | dose escalation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inotuzumab Ozogamicin | Drug | starting dose 0.8 mg/m2, d1 administration, q4wks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Antitumor activity based on Cheson criteria | after 12-18 months form the first patient in |
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Key inclusion criteria
Key exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Anastasios Stathis, Dr. | Oncology Institute of Southern Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| InselSpital, Universitätsspital Bern | Bern | Canton of Bern | 3010 | Switzerland | ||
| Oncology Institute of Southern Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34407735 | Derived | Pirosa MC, Zhang L, Hitz F, Novak U, Hess D, Terrot T, Pascale M, Mazzucchelli L, Bertoni F, Cavalli F, Zucca E, Stathis A. A phase I trial of inotuzumab ozogamicin in combination with temsirolimus in patients with relapsed or refractory CD22-positive B-cell non-Hodgkin lymphomas. Leuk Lymphoma. 2022 Jan;63(1):117-123. doi: 10.1080/10428194.2021.1966780. Epub 2021 Aug 19. |
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| ID | Term |
|---|---|
| D000080045 | Inotuzumab Ozogamicin |
| C401859 | temsirolimus |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
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| Temsirolimus | Drug | starting dose of 15mg, weekly administration, q4ws |
|
|
| Bellinzona |
| Canton Ticino |
| 6500 |
| Switzerland |
| Kantonsspital St.Gallen | San Gallen | San Gallen | 9007 | Switzerland |
| D061067 |
| Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |