Trial Information
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
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
number of participants with adverse events based on the CTCAE v.4
Outcome Description:
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
Outcome Time Frame:
toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks
Safety Issue:
Yes
Principal Investigator
Anastasios Stathis, Dr.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Oncology Institute of Southern Switzerland
Authority:
Switzerland: Swissmedic
Study ID:
IOSI-LND-001
NCT ID:
NCT01535989
Start Date:
December 2011
Completion Date:
December 2013
Related Keywords:
- B-cell Lymphoma Refractory
- B-cell Non Hodgkin's Lymphomas
- CD22 positive
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell