Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL)
NCT00562965
ABOUT THIS STUDY
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Pfizer Clinical Trials Contact Center
1-800-718-1021
- Subjects with a diagnosis of CD20 and CD22-positive, follicular lymphoma, who have received 1 or 2 prior regimens, at least 1 of which should have contained administration of rituximab (either as a single agent or in combination).
- Age 18 years or older.
- ECOG performance status <= 2.
- ANC >= 1.5 x 10^9/L (1500/mL) and platelets >= 75 x 10^9/L (75,000/mL), serum creatinine <= 1.5 x ULN and urine protein to creatinine ratio of <= 0.5, total bilirubin <= 1.5 x ULN, AST and ALT <= 2.5 x ULN.
- At least 1 measurable disease lesion that is >= 1.5 cm x 1.5 cm by CT or MRI, in an area of no prior radiation therapy, or documented progression in an area that was previously irradiated.
- Subjects with clinical evidence of transformation to a more aggressive subtype of
lymphoma or grade 3b follicular lymphoma.
- Subjects whose disease is rituximab refractory, meaning that they did not have a CR or
PR, or that they experienced disease progression within 6 months from the initiation
of the rituximab or rituximab containing treatment regimen administered immediately
preceding study enrollment.
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Descriptive Information | ||||
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Brief Title ICMJE | Study Comparing Inotuzumab Ozogamicin In Combination With Rituximab Versus Defined Investigator's Choice In Follicular Non-Hodgkin's Lymphoma (NHL) | |||
Official Title ICMJE | An Open-label, Randomized, Phase 3 Study Of Inotuzumab Ozogamicin (Cmc-544) Administered In Combination With Rituximab Compared To A Defined Investigator's Choice Therapy In Subjects With Relapsed Or Refractory, Cd22- Positive, Follicular B-cell Non Hodgkin's Lymphoma | |||
Brief Summary | This protocol is designed to assess the efficacy and safety of inotuzumab ozogamicin given with rituximab compared to a defined investigator's choice therapy. Subjects will be randomized to one of these two arms of the study. | |||
Detailed Description | On January 14th 2009, enrollment in the study was discontinued because of poor enrollment and because it was unlikely that the study would meet the estimated enrollment of approximately 978 subjects. The decision was not prompted by the identification of any safety signals in this or other studies. Active treatment and follow-up of the already enrolled subjects was continued. On July, 22th 2010 , the study was amended to shorten the long-term follow-up to one year after active treatment. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Health Services Research | |||
Condition ICMJE | Lymphoma, Follicular | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE | 29 | |||
Original Estimated Enrollment ICMJE | 978 | |||
Actual Study Completion Date ICMJE | April 2011 | |||
Actual Primary Completion Date | April 2011 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Argentina, Belgium, Canada, Hong Kong, India, Italy, Korea, Republic of, Mexico, Poland, Portugal, Russian Federation, South Africa, Spain, United States | |||
Removed Location Countries | Australia, Brazil, Chile, Colombia, Costa Rica, Croatia, Czech Republic, Former Serbia and Montenegro, France, Germany, Guatemala, Hungary, Panama, Peru, Puerto Rico, Serbia, Singapore, Slovakia, Taiwan, Thailand | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00562965 | |||
Other Study ID Numbers ICMJE | 3129K4-3301 B1931006 ( Other Identifier: Alias Study Number ) 2007-000219-27 ( EudraCT Number ) | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | UCB Pharma | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | December 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |