A Phase 1 Study Of Inotuzumab Ozogamicin (CMC-544) Administered In Combination With Rituximab In Subjects With B-Cell Non-Hodgkin's Lymphoma
Phase 1
20 Years
74 Years
20 Years
74 Years
Not Enrolling
Both
Lymphoma, B-Cell
Both
Lymphoma, B-Cell
Trial Information
A Phase 1 Study Of Inotuzumab Ozogamicin (CMC-544) Administered In Combination With Rituximab In Subjects With B-Cell Non-Hodgkin's Lymphoma
Inclusion Criteria:
- CD20 and CD22-positive, B-cell NHL which has progressed after 1 or 2 prior therapies.
- Prior therapy must have contained at least one dose of Rituximab therapy. Patients
can not be refractory to Rituximab (refractory = PD under treatment or within 6 month
- Eastern Cooperative Oncology Group (ECOG) performance status: 0/ 1.
- Patients must not have received previous radioimmunotherapy.
- Patients tolerant to Rituximab.
- Patients must not have received chemotherapy, cancer immunosuppressive therapy,
growth factors (except erythropoietin), or investigational agents within 28 days
before first dose of test article.
Exclusion Criteria:
- Candidate for potentially curative therapies
- Subjects must not have received previous radioimmunotherapy.
- Subjects with autologous hematopoietic stem cell transplant within the last 6 months
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Safety: physical examinations (with vital signs) and laboratory test measurements.
Outcome Time Frame:
A maximum of 16 months
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
3129K3-1104
NCT ID:
NCT00724971
Start Date:
July 2008
Completion Date:
March 2010
Related Keywords:
- Lymphoma, B-Cell
- B-cell Non-Hodgkin's Lymphoma
- NHL
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
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