This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
- CD22 expression
- Adequate liver and renal functions
- Isolated extramedullary disease
- Active Central Nervous System [CNS] disease
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | |||||||
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| Brief Title ICMJE | A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia | ||||||
| Official Title ICMJE | AN OPEN-LABEL, RANDOMIZED PHASE 3 STUDY OF INOTUZUMAB OZOGAMICIN COMPARED TO A DEFINED INVESTIGATOR'S CHOICE IN ADULT PATIENTS WITH RELAPSED OR REFRACTORY CD22-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) | ||||||
| Brief Summary | This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Phase 3 | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
| Condition ICMJE | Acute Lymphoblastic Leukemia | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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| * 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 | Completed | ||||||
| Actual Enrollment ICMJE | 326 | ||||||
| Original Estimated Enrollment ICMJE | 292 | ||||||
| Actual Study Completion Date ICMJE | January 4, 2017 | ||||||
| Actual Primary Completion Date | March 8, 2016 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| 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, Australia, Canada, China, Czechia, Finland, France, Germany, Hungary, Italy, Japan, Korea, Republic of, Netherlands, Poland, Singapore, Spain, Sweden, Taiwan, United Kingdom, United States | ||||||
| Removed Location Countries | Belgium, Brazil, Croatia, Czech Republic, Serbia, Slovakia | ||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT01564784 | ||||||
| Other Study ID Numbers ICMJE | B1931022 2011-005491-41 ( EudraCT Number ) | ||||||
| Has Data Monitoring Committee | Yes | ||||||
| U.S. FDA-regulated Product | Not Provided | ||||||
| IPD Sharing Statement ICMJE |
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| Responsible Party | Pfizer | ||||||
| Study Sponsor ICMJE | Pfizer | ||||||
| Collaborators ICMJE | UCB Pharma | ||||||
| Investigators ICMJE |
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| PRS Account | Pfizer | ||||||
| Verification Date | December 2018 | ||||||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | |||||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
