Clinical trial NCT01535989: Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma
Official title: A Phase I Study of Inotuzumab Ozogamicin (CMC-544) in Combination With Temsirolimus (CCI-779) in Patients With Relapsed or Refractory CD22-positive B-cell Non Hodgkin's Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: B-cell Lymphoma Refractory
Keywords: B-cell Non Hodgkin's Lymphomas
CD22 positive
Lead sponsor: Oncology Institute of Southern Switzerland
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: number of participants with adverse events based on the CTCAE v.4
timeFrame: toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks
Secondary outcomes:
measure: Antitumor activity based on Cheson criteria
timeFrame: after 12-18 months form the first patient in
Other outcomes:
Locations:
city: Bellinzona
country: Switzerland
facility: Oncology Institute of Southern Switzerland
state: Ticino
city: Bern
country: Switzerland
facility: InselSpital, Universitätsspital Bern
city: San Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
Study officials:
affiliation: Oncology Institute of Southern Switzerland
name: Anastasios Stathis, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.