A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Pfizer
Collaborator:
Union Chimique Belge
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01564784
First received: March 26, 2012
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Lymphoblastic Leukemia |
Drug: inotuzumab ozogamicin Drug: FLAG (fludarabine, cytarabine and G-CSF) Drug: HIDAC (high dose cytarabine) Drug: cytarabine and mitoxantrone |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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) |
Resource links provided by NLM:
Drug Information available for:
Cytarabine
Fludarabine
Mitoxantrone
Mitoxantrone hydrochloride
Fludarabine phosphate
U.S. FDA Resources
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Response to therapy (percentage of patients achieving a complete response and complete response with incomplete platelet and/or neutrophil recovery). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Overall Survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
- Progression free survival [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
- Volume of distribution (Vd) for inotuzumab ozogamicin in serum [ Time Frame: Cycle 1, Days 1, 3, 8 and 15; Cycle 2 , Days 1 and 8; Cycle 4, Days 1 and 8 ] [ Designated as safety issue: No ]
- Systemic clearance (CL) for inotuzumab ozogamicin in serum [ Time Frame: Cycle 1, Days 1, 3, 8 and 15; Cycle 2 , Days 1 and 8; Cycle 4, Days 1 and 8 ] [ Designated as safety issue: No ]
- Duration of response [ Time Frame: Baseline to 24 months ] [ Designated as safety issue: No ]
- Rate of stem-cell transplantation: percentage of patients having stem-cell transplant [ Time Frame: Baseline to 8 months ] [ Designated as safety issue: No ]
- Minimal residual disease (MRD): number of leukemic cells in bone marrow after CR/CRi [ Time Frame: Baseline to 7 months ] [ Designated as safety issue: No ]
- Cytogenetics: quantitate t(9;22), MLL, and IGH rearrangements in leukemia cells [ Time Frame: Baseline to 7 months ] [ Designated as safety issue: No ]
- Quality of life: . EORTC QLQ-C30 = European Organization for Research and Treatment of Cancer. Quality of Life Questionnaire, Core-30 [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
- Quality of life: EQ-5D = EuroQual -5D Health Questionnaire [ Time Frame: Baseline to 6 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 292 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | March 2015 |
| Estimated Primary Completion Date: | June 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm A |
Drug: inotuzumab ozogamicin
Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
|
| Active Comparator: Arm B |
Drug: FLAG (fludarabine, cytarabine and G-CSF)
Dose: cytarabine 2.0 g/m^2/day IV days 1-6 fludarabine30 mg/m^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4
Drug: HIDAC (high dose cytarabine)
cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
Drug: cytarabine and mitoxantrone
mitoxantrone 12 mg/m^2 IV days 1-3 cytarabine 200 mg/m^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- CD22 expression
- Adequate liver and renal functions
Exclusion Criteria:
- Isolated extramedullary disease
- Active Central Nervous System [CNS] disease
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01564784
Hide Study Locations
Contacts
| Contact: Pfizer CT.gov Call Center | 1-800-718-1021 |
Hide Study LocationsLocations
| United States, California | |
| Pfizer Investigational Site | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Pfizer Investigational Site | Recruiting |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| Pfizer Investigational Site | Recruiting |
| Aurora, Colorado, United States, 80045 | |
| United States, Florida | |
| Pfizer Investigational Site | Recruiting |
| Orlando, Florida, United States, 32806 | |
| United States, Georgia | |
| Pfizer Investigational Site | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Pfizer Investigational Site | Not yet recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Pfizer Investigational Site | Recruiting |
| Augusta, Georgia, United States, 30912 | |
| United States, Illinois | |
| Pfizer Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Pfizer Investigational Site | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| United States, Kansas | |
| Pfizer Investigational Site | Recruiting |
| Kansas City, Kansas, United States, 66160 | |
| Pfizer Investigational Site | Recruiting |
| Westwood, Kansas, United States, 66205 | |
| United States, Maryland | |
| Pfizer Investigational Site | Recruiting |
| Baltimore, Maryland, United States, 21287 | |
| United States, Massachusetts | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02215 | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Pfizer Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| United States, Michigan | |
| Pfizer Investigational Site | Recruiting |
| Ann Arbor, Michigan, United States, 48109 | |
| Pfizer Investigational Site | Recruiting |
| Detroit, Michigan, United States, 48201 | |
| United States, New Jersey | |
| Pfizer Investigational Site | Recruiting |
| Hackensack, New Jersey, United States, 07601 | |
| United States, New Mexico | |
| Pfizer Investigational Site | Recruiting |
| Albuquerque, New Mexico, United States, 87106 | |
| United States, New York | |
| Pfizer Investigational Site | Not yet recruiting |
| Lake Success, New York, United States, 11042 | |
| Pfizer Investigational Site | Not yet recruiting |
| Manhasset, New York, United States, 11030 | |
| Pfizer Investigational Site | Recruiting |
| New York, New York, United States, 10065 | |
| Pfizer Investigational Site | Recruiting |
| New York, New York, United States, 10021 | |
| Pfizer Investigational Site | Recruiting |
| Stony Brook, New York, United States, 11794 | |
| United States, Ohio | |
| Pfizer Investigational Site | Recruiting |
| Cleveland, Ohio, United States, 44106 | |
| Pfizer Investigational Site | Recruiting |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Pfizer Investigational Site | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, South Carolina | |
| Pfizer Investigational Site | Recruiting |
| Easley, South Carolina, United States, 29640 | |
| Pfizer Investigational Site | Recruiting |
| Greenville, South Carolina, United States, 29615 | |
| Pfizer Investigational Site | Recruiting |
| Greenville, South Carolina, United States, 29605 | |
| Pfizer Investigational Site | Recruiting |
| Greer, South Carolina, United States, 29650 | |
| Pfizer Investigational Site | Recruiting |
| Seneca, South Carolina, United States, 29672 | |
| Pfizer Investigational Site | Recruiting |
| Spartanburg, South Carolina, United States, 29307 | |
| United States, Texas | |
| Pfizer Investigational Site | Recruiting |
| Dallas, Texas, United States, 75246 | |
| Pfizer Investigational Site | Recruiting |
| Houston, Texas, United States, 77030 | |
| Pfizer Investigational Site | Recruiting |
| Laredo, Texas, United States, 78041 | |
| Pfizer Investigational Site | Recruiting |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Pfizer Investigational Site | Recruiting |
| Salt Lake City, Utah, United States, 84103 | |
| United States, West Virginia | |
| Pfizer Investigational Site | Recruiting |
| Morgantown, West Virginia, United States, 26506 | |
| Australia, Victoria | |
| Pfizer Investigational Site | Recruiting |
| Box Hill, Victoria, Australia, 3128 | |
| Canada, Ontario | |
| Pfizer Investigational Site | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Croatia | |
| Pfizer Investigational Site | Not yet recruiting |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| Pfizer Investigational Site | Not yet recruiting |
| Prague, CZ, Czech Republic, 100-34 | |
| Pfizer Investigational Site | Recruiting |
| Bmo, Czech Republic, 62500 | |
| Pfizer Investigational Site | Recruiting |
| Hradec Kralove, Czech Republic, 50005 | |
| Pfizer Investigational Site | Not yet recruiting |
| Olomouc, Czech Republic, 77520 | |
| Finland | |
| Pfizer Investigational Site | Recruiting |
| Helsinki, Finland, 00290 | |
| France | |
| Pfizer Investigational Site | Not yet recruiting |
| Le Chesnay, France, 78157 | |
| Pfizer Investigational Site | Not yet recruiting |
| Marseille, France, 13009 | |
| Pfizer Investigational Site | Not yet recruiting |
| Paris CEDEX 10, France, 75475 | |
| Pfizer Investigational Site | Not yet recruiting |
| Toulouse, Cedex 9, France, 31059 | |
| Germany | |
| Pfizer Investigational Site | Not yet recruiting |
| Kiel, Germany, 24116 | |
| Pfizer Investigational Site | Not yet recruiting |
| Muenchen, Germany, 81675 | |
| Pfizer Investigational Site | Recruiting |
| Muenster, Germany, 48149 | |
| Pfizer Investigational Site | Not yet recruiting |
| Oldenburg, Germany, 26133 | |
| Hungary | |
| Pfizer Investigational Site | Not yet recruiting |
| Budapest, Hungary, 1097 | |
| Pfizer Investigational Site | Not yet recruiting |
| Debrecen, Hungary, 4032 | |
| Italy | |
| Pfizer Investigational Site | Recruiting |
| Bologna, Italy, 40138 | |
| Pfizer Investigational Site | Not yet recruiting |
| Catania, Italy | |
| Pfizer Investigational Site | Not yet recruiting |
| Genova, Italy, 16132 | |
| Pfizer Investigational Site | Not yet recruiting |
| Monza, Italy, 20052 | |
| Pfizer Investigational Site | Not yet recruiting |
| Udine, Italy, 33100 | |
| Japan | |
| Pfizer Investigational Site | Recruiting |
| Sendai, Miyagi, Japan | |
| Pfizer Investigational Site | Not yet recruiting |
| Chuo-ku, Tokyo, Japan | |
| Pfizer Investigational Site | Not yet recruiting |
| Itabashi, Tokyo, Japan | |
| Pfizer Investigational Site | Not yet recruiting |
| Koto-Ku, Tokyo, Japan | |
| Pfizer Investigational Site | Recruiting |
| Aichi, Japan | |
| Pfizer Investigational Site | Recruiting |
| Akita, Japan | |
| Pfizer Investigational Site | Recruiting |
| Fukuoka, Japan | |
| Pfizer Investigational Site | Not yet recruiting |
| Hyogo, Japan | |
| Pfizer Investigational Site | Recruiting |
| Kanagawa, Japan | |
| Pfizer Investigational Site | Not yet recruiting |
| Tokyo, Japan | |
| Korea, Republic of | |
| Pfizer Investigational Site | Not yet recruiting |
| Hwasun-Gun, Jeonnam, Korea, Republic of, 519-763 | |
| Pfizer Investigational Site | Not yet recruiting |
| Busan, Korea, Republic of, 614-735 | |
| Pfizer Investigational Site | Not yet recruiting |
| Incheon, Korea, Republic of, 405-760 | |
| Pfizer Investigational Site | Not yet recruiting |
| Seoul, Korea, Republic of, 135 710 | |
| Pfizer Investigational Site | Not yet recruiting |
| Seoul, Korea, Republic of, 110 744 | |
| Pfizer Investigational Site | Not yet recruiting |
| Seoul, Korea, Republic of, 137-701 | |
| Pfizer Investigational Site | Not yet recruiting |
| Seoul, Korea, Republic of, 138-736 | |
| Pfizer Investigational Site | Not yet recruiting |
| Seoul, Korea, Republic of, 140-743 | |
| Poland | |
| Pfizer Investigational Site | Not yet recruiting |
| Warsaw, Poland, 02-776 | |
| Singapore | |
| Pfizer Investigational Site | Recruiting |
| Singapore, Singapore, 169608 | |
| Pfizer Investigational Site | Not yet recruiting |
| Singapore, Singapore, 119074 | |
| Slovakia | |
| Pfizer Investigational Site | Not yet recruiting |
| Bratislava, Slovakia, 851 07 | |
| Pfizer Investigational Site | Not yet recruiting |
| Kosice, Slovakia, 041 66 | |
| Spain | |
| Pfizer Investigational Site | Not yet recruiting |
| Badalona, Barcelona, Spain, 08916 | |
| Pfizer Investigational Site | Not yet recruiting |
| L'Hospitalet de Llobregat, Barcelona, Spain, 08908 | |
| Pfizer Investigational Site | Not yet recruiting |
| Barcelona, Catalunya, Spain, 00 | |
| Pfizer Investigational Site | Not yet recruiting |
| Palma de Mallorca, Illes Balears, Spain, 07198 | |
| Pfizer Investigational Site | Not yet recruiting |
| Barcelona, Spain | |
| Pfizer Investigational Site | Not yet recruiting |
| Madrid, Spain, 28007 | |
| Pfizer Investigational Site | Not yet recruiting |
| Madrid, Spain, 28041 | |
| Pfizer Investigational Site | Not yet recruiting |
| Madrid, Spain | |
| Pfizer Investigational Site | Not yet recruiting |
| Madrid, Spain, 28046 | |
| Pfizer Investigational Site | Not yet recruiting |
| Murcia, Spain, 30008 | |
| Pfizer Investigational Site | Not yet recruiting |
| Salamanca, Spain | |
| Pfizer Investigational Site | Not yet recruiting |
| Sevilla, Spain, 41013 | |
| Pfizer Investigational Site | Not yet recruiting |
| Valencia, Spain, 46010 | |
| Sweden | |
| Pfizer Investigational Site | Recruiting |
| Lund, Sweden, 221 85 | |
| Pfizer Investigational Site | Recruiting |
| Stockholm, Sweden, 171 76 | |
| Pfizer Investigational Site | Not yet recruiting |
| Uppsala, Sweden, 751 85 | |
| Taiwan | |
| Pfizer Investigational Site | Not yet recruiting |
| Kaohsiung, Taiwan, 83301 | |
| Pfizer Investigational Site | Not yet recruiting |
| Taichung, Taiwan, 40705 | |
| Pfizer Investigational Site | Not yet recruiting |
| Taipei, Taiwan, 100 | |
| United Kingdom | |
| Pfizer Investigational Site | Not yet recruiting |
| Oxford, Oxon, United Kingdom, OX3 7LJ | |
| Pfizer Investigational Site | Not yet recruiting |
| Bristol, United Kingdom, BS2 8BJ | |
| Pfizer Investigational Site | Not yet recruiting |
| Bristol, United Kingdom, BS2 8ED | |
| Pfizer Investigational Site | Not yet recruiting |
| London, United Kingdom, NW3 2QG | |
| Pfizer Investigational Site | Not yet recruiting |
| Manchester, United Kingdom, M20 4BX | |
| Pfizer Investigational Site | Not yet recruiting |
| NorthHumberside, United Kingdom, Hu16 5JQ | |
| Pfizer Investigational Site | Not yet recruiting |
| Southampton, United Kingdom, SO16 6YD | |
Sponsors and Collaborators
Pfizer
Union Chimique Belge
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01564784 History of Changes |
| Other Study ID Numbers: | B1931022 |
| Study First Received: | March 26, 2012 |
| Last Updated: | June 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Leukemia Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Cytarabine Fludarabine monophosphate Fludarabine Mitoxantrone Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiviral Agents Anti-Infective Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 18, 2013