An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Lymphoma, Non-Hodgkin
Both
Lymphoma, Non-Hodgkin
Trial Information
An Open-Label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin Administered In Combination With Rituximab Compared To Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory CD22-Positive Aggressive Non-Hodgkin Lymphoma Who Are Not Candidates For Intensive High-Dose Chemotherapy
Inclusion Criteria:
- relapsed/refractory/persistent CD20+/CD22+ aggressive NHL (DLBCL, transformed
indolent lymphoma with DLBCL, primary mediastinal large B-cell lymphomas)
- up to 3 prior regimens containing cytotoxic chemotherapies
- not candidates for intensive high-dose chemotherapy, with or without an autologous
stem cell transplant
Exclusion Criteria:
- Any prior allogeneic hematopoietic stem cell transplant; autotransplant within prior
4 months
- anti-CD22 treatment or radioimmunotherapy within prior 6 months
- contraindication to both investigator choice regimens
- chronic liver disease, history of veno-occlusive disease
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Overall Survival
Outcome Time Frame:
5 years
Safety Issue:
No
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
United States: Food and Drug Administration
Study ID:
B1931008
NCT ID:
NCT01232556
Start Date:
April 2011
Completion Date:
August 2018
Related Keywords:
- Lymphoma, Non-Hodgkin
- inotuzumab ozogamicin
- aggressive Non-Hodgkin lymphoma
- diffuse large b-cell lymphoma
- relapsed/refractory lymphoma
- Aggression
- Lymphoma
- Lymphoma, Non-Hodgkin
Name | Location |
|---|---|
| Pfizer Investigational Site | Blendora, California 91740 |
| Pfizer Investigational Site | Atlanta, Georgia 30342 |
| Pfizer Investigational Site | Crestview Hills, Kentucky 41017 |
| Pfizer Investigational Site | Detroit, Michigan 48201 |
| Pfizer Investigational Site | Rochester, Minnesota 55905 |
| 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 | Federal Way, Washington 98003 |
| Pfizer Investigational Site | Clearwater, Florida 33761 |
| Pfizer Investigational Site | Carmel, Indiana 46032 |
| Pfizer Investigational Site | Cedar Rapids, Iowa 52403 |
| Pfizer Investigational Site | Kansas City, Kansas 66112 |
| Pfizer Investigational Site | Columbia, Missouri 65201 |
| Pfizer Investigational Site | Bartlesville, Oklahoma 74006 |
| Pfizer Investigational Site | Eugene, Oregon 97401 |
| Pfizer Investigational Site | Kingston, Pennsylvania 18704-5535 |
| Pfizer Investigational Site | Shreveport, Louisiana 71103 |
| Pfizer Investigational Site | Omaha, Nebraska 68198 |
| Pfizer Investigational Site | Bristol, Tennessee 37620 |
| Pfizer Investigational Site | Washington, District of Columbia 20007-2197 |
| Pfizer Investigational Site | Lebanon, New Hampshire 03766 |
| Pfizer Investigational Site | Lewistown, Idaho 83501 |
| Pfizer Investigational Site | Morgantown, West Virginia 26506 |
