Lymphoma, B-Cell
Conditions
Keywords
B-cell Non-Hodgkin's Lymphoma, NHL
Brief summary
To assess the tolerability and the initial safety profile of Inotuzumab Ozogamicin (CMC-544) in patients with B-Cell Non-Hodgkin's Lymphoma (NHL).
Interventions
Intravenous (IV) infusion, 1.3 - 1.8 mg/m2, every 28 days, 4 cycles
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
* CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies. * Patients who have progressed after at least 1 prior chemotherapy regimen for indolent lymphoma, or 1/ 2 chemotherapy regimens, which include anthracylin or anthraquinon for aggressive lymphoma. * Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
Exclusion criteria
* Patients must not have received monoclonal antibodies or radioimmunoconjugates within 3 months before first dose of test article. * Patients must not have received bilateral pelvic irradiation. * Patients must not have received chemotherapy, cancer immunosuppressive therapy, growth factors (except erythropoietin), or investigational agents within 4 weeks before first dose of test article.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results. | 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Tumor response (according to the International Response Criteria for Non-Hodgkin's Lymphomas). | 4 months |
Outcome results
None listed