Trial Information
A Phase 1/2 Study Of CMC-544 Administered In Combination With Rituximab In Subjects With Follicular Or Diffuse Large B-Cell Non-Hodgkin's Lymphoma
Inclusion Criteria:
- Subjects with CD20 and CD22-positive, follicular or diffuse large B-cell NHL who have
not responded or progressed after 1 or 2 prior therapies; or subjects with CD20 and
CD22-positive intermediate/aggressive NHL (diffuse large B-cell, mantle cell,
transformed follicular or follicular grade 3b NHL) who have not responded or
progressed after 1 or more prior therapies and are refractory to a previous rituximab
containing therapy.
- Prior therapy must contain at least one course of rituximab therapy, as single agent
or in combination.
- Measurable disease.
Exclusion Criteria:
- Subjects who are candidates for other potentially curative therapies.
- Subjects must not have received previous radioimmunotherapy.
- Subjects who have undergone a prior bone marrow transplantation within the last 6
months.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determination of MTD and safety as measured by the incidence of AEs
Outcome Time Frame:
Up to 5 years
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
3129K3-101
NCT ID:
NCT00299494
Start Date:
May 2006
Completion Date:
May 2014
Related Keywords:
- Lymphoma, B-Cell
- Lymphoma
- NHL
- Lymphoma
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
Name | Location |
Pfizer Investigational Site |
Birmingham, Alabama 35205 |
Pfizer Investigational Site |
Blendora, California 91740 |
Pfizer Investigational Site |
Atlanta, Georgia 30342 |
Pfizer Investigational Site |
Cincinnait, Ohio 45236 |
Pfizer Investigational Site |
Springfield, Illinois 62701-1014 |
Pfizer Investigational Site |
Bronx, New York 10461 |
Pfizer Investigational Site |
Houston, Texas 77030 |
Pfizer Investigational Site |
Las Vegas, Nevada 89128 |
Pfizer Investigational Site |
Kingston, Pennsylvania 18704-5535 |