Study of Inotuzumab Ozogamicin + Temsirolimus in Patients With Relapsed or Refractory CD22+ B-cell NHLymphoma
Conditions
B-cell Lymphoma Refractory
Conditions: official terms
Lymphoma, B-Cell
Conditions: Keywords
B-cell Non Hodgkin's Lymphomas, CD22 positive
Study Type
Interventional
Study Phase
Phase 1
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Inotuzumab Ozogamicin Type: Drug
Name: Temsirolimus Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Locations
Dr. Anastasios Stathis
Bellinzona, Ticino, Switzerland
Status: Recruiting
Contact: Anastasios Stathis, Dr - +41918118931 - anastasios.stathis@eoc.ch
Dr. Urban Novak
Bern, Switzerland
Status: Recruiting
Contact: Urban Novak, MD - +41316321992 - urban.novak@insel.ch
Dr. Felicitas Hitz
San Gallen, Switzerland
Status: Recruiting
Contact: Felicitas Hitz, Dr - +41714941111 - felicitas.hitz@kssg.ch
Start Date
December 2011
Completion Date
December 2015
Sponsors
Cristiana Sessa
Source
Oncology Institute of Southern Switzerland
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page