A Phase 1 Study Of CMC-544 Administered As A Single Agent 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 CMC-544 Administered As A Single Agent In Subjects With B-Cell Non-Hodgkin's Lymphoma
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence and severity of adverse events, dose-limiting toxicities, and changes in laboratory test results.
Outcome Time Frame:
4 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:
3129K1-103
NCT ID:
NCT00717925
Start Date:
March 2007
Completion Date:
July 2008
Related Keywords:
- Lymphoma, B-Cell
- B-cell Non-Hodgkin's Lymphoma
- NHL
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
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