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
Key inclusion criteria
- Histologically and/or cytologically confirmed relapsed or refractory CD22+ B-cell Non
- No limitations on prior treatments. Patients must have progressed after at least one
- 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:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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
Outcome Time Frame:
toxicities will be assessed during the participation of each patient in the study, an expected average of 8 weeks
Anastasios Stathis, Dr.
Oncology Institute of Southern Switzerland
- B-cell Lymphoma Refractory
- B-cell Non Hodgkin's Lymphomas
- CD22 positive
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell