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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-005491-41 | EudraCT Number |
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| Name | Class |
|---|---|
| UCB Pharma | INDUSTRY |
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This study will compare the efficacy, in terms of complete responses and overall survival, of inotuzumab ozogamicin versus investigator's choice of chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental |
| |
| Arm B | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| inotuzumab ozogamicin | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) | CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL. | Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose |
| Overall Survival (OS) | OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact. | Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) | DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Drug Services - UC San Diego Moores Cancer Center | La Jolla | California | 92037-0845 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38607410 | Derived | Zhao Y, Laird AD, Roberts KG, Yafawi R, Kantarjian H, DeAngelo DJ, Stelljes M, Liedtke M, Stock W, Gokbuget N, O'Brien S, Jabbour E, Cassaday RD, Loyd MR, Olsen S, Neale G, Liu X, Vandendries E, Advani A, Mullighan CG. Association of leukemic molecular profile with efficacy of inotuzumab ozogamicin in adults with relapsed/refractory ALL. Blood Adv. 2024 Jun 25;8(12):3226-3236. doi: 10.1182/bloodadvances.2023012430. | |
| 35643855 |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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164 participants were randomized to Inotuzumab Ozogamicin and 162 to Defined Investigator's Choice of Chemotherapy. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the intention-to-treat (ITT) population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Inotuzumab Ozogamicin | Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| FLAG (fludarabine, cytarabine and G-CSF) | Drug | 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 |
|
| HIDAC (high dose cytarabine) | Drug | cytarabine 3 g/m^2 IV every 12 hours for up to 12 times |
|
| cytarabine and mitoxantrone | Drug | 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 |
|
| Up to 2 years from randomization |
| Progression-Free Survival (PFS) | PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method. | Up to 2 years from randomization |
| Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) | HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy. | Up to 19 weeks from last dose |
| Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) | MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was <1 × 10^-4 blasts/nucleated cells. | Up to approximately 4 weeks (EoT) from last dose of study drug |
| Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) | Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening. | Up to approximately 4 weeks (EoT) from last dose of study drug |
| Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing | Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations). | Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4 |
| Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score | This questionnaire comprised 30 questions within which are 9 multi-item scales & 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional & social, 3 symptom scales; fatigue, pain, & nausea & vomiting, & a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, & dyspnea) & a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged & transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms. | Day 1 of each cycle prior to dosing and EoT |
| Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score | The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). | Day 1 of each cycle prior to dosing and EoT |
| Change From Baseline in EQ-5D VAS | The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. | Day 1 of each cycle prior to dosing and EoT |
| Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT | VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules. | Up to 2 years from randomization |
| UC San Diego Medical Center - La Jolla |
| La Jolla |
| California |
| 92037 |
| United States |
| UC San Diego Moores Cancer Center | La Jolla | California | 92093-0698 | United States |
| Children's Center for Cancer and Blood Diseases, Childrens Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Keck Hospital of USC | Los Angeles | California | 90033 | United States |
| LAC+USC Medical Center | Los Angeles | California | 90033 | United States |
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| USC/Norris Comprehensive Cancer Center / Investigational Drug Services | Los Angeles | California | 90033 | United States |
| USC/Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States |
| UCLA Drug Information/Investigation Drug | Los Angeles | California | 90095 | United States |
| UCLA Hematology/Oncology Clinic | Los Angeles | California | 90095 | United States |
| UCLA Ronald Reagan Medical Center | Los Angeles | California | 90095 | United States |
| UCLA Rrmc | Los Angeles | California | 90095 | United States |
| UC Irvine Medical Center | Orange | California | 92868-3201 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| UC Irvine Medical Center | Orange | California | 92868 | United States |
| Freidenrich Center for Translational Research (CTRU), Stanford University | Palo Alto | California | 94304 | United States |
| UC San Diego Medical Center - Hillcrest | San Diego | California | 92103 | United States |
| Martha Hamilton, Investigational Drug Services, Dept of Pharmacy | Stanford | California | 94305 | United States |
| Stanford Cancer Institute | Stanford | California | 94305 | United States |
| Stanford University Hospital and Clinics | Stanford | California | 94305 | United States |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital, Cancer Center Infusion Center | Aurora | Colorado | 80045 | United States |
| University of Colorado Hospital | Aurora | Colorado | 80045 | United States |
| Yale-New Haven Hospital & Smilow Cancer Center | New Haven | Connecticut | 06510 | United States |
| Miami Children's Hospital | Miami | Florida | 33155 | United States |
| MD Anderson Cancer Center Orlando - 5th Floor Investigational Pharmacy | Orlando | Florida | 32806 | United States |
| MD Anderson Cancer Center Orlando | Orlando | Florida | 32806 | United States |
| Orlando Heart Health Institute | Orlando | Florida | 32806 | United States |
| Orlando Regional Medical Center | Orlando | Florida | 32806 | United States |
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| Investigational Drug Service, Emory University Clinic | Atlanta | Georgia | 30322 | United States |
| The Emory Clinic | Atlanta | Georgia | 30322 | United States |
| Winship Cancer Institute, Emory University | Atlanta | Georgia | 30322 | United States |
| Blood and Marrow Transplant Group of Georgia | Atlanta | Georgia | 30342 | United States |
| Northside Hospital | Atlanta | Georgia | 30342 | United States |
| Georgia Regents Medical Center Pharmacy, Georgia Regents University Cancer Center | Augusta | Georgia | 30912 | United States |
| Georgia Regents University | Augusta | Georgia | 30912 | United States |
| Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | United States |
| Northwestern Medicine Developmental Therapeutics Institute | Chicago | Illinois | 60611 | United States |
| Northwestern Memorial Hospital | Chicago | Illinois | 60611 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Chicago Medical Center, Dept. of Pharmacy | Chicago | Illinois | 60637 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| University of Kansas Hospital | Kansas City | Kansas | 66160 | United States |
| University of Kansas Cancer Center | Westwood | Kansas | 66205 | United States |
| Norton Cancer Institute | Louisville | Kentucky | 40202 | United States |
| Norton Cancer Institute, Suburban | Louisville | Kentucky | 40207 | United States |
| University of Maryland | Baltimore | Maryland | 21201 | United States |
| Oncology Investigational Drug Service | Baltimore | Maryland | 21231-2410 | United States |
| The Sidney Kimmel Comprehensive Cancer Center | Baltimore | Maryland | 21231-2410 | United States |
| Massachusetts General Hospital (MGH) | Boston | Massachusetts | 02114 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02215 | United States |
| University of Michigan Health System- | Ann Arbor | Michigan | 48109 | United States |
| Karmanos Cancer Institute | Detroit | Michigan | 48201 | United States |
| Karmanos Cancer Institute Weisberg Cancer Treatment Center | Farmington Hills | Michigan | 48334 | United States |
| Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| John Theurer Cancer Center at Hackensack University Medical Center | Hackensack | New Jersey | 07601 | United States |
| Rutgers Cancer Institute of New Jersey | New Brunswick | New Jersey | 08903 | United States |
| University of New Mexico Comprehensive Cancer Center | Albuquerque | New Mexico | 87131-0001 | United States |
| UNM Cancer Center | Albuquerque | New Mexico | 87131 | United States |
| Monter Cancer Center | Lake Success | New York | 11042 | United States |
| North Shore University Hospital | Manhasset | New York | 11030 | United States |
| New York Presbyterian Hospital-Weill Cornell Medical College | New York | New York | 10021 | United States |
| NewYork-Presbyterian Hospital | New York | New York | 10065 | United States |
| Weill Cornell Medical College - New York-Presbyterian Hospital | New York | New York | 10065 | United States |
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794-7007 | United States |
| Stony Brook University Medical Center, The Cancer Center | Stony Brook | New York | 11794-9447 | United States |
| Division of Hematology/Oncology, Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Stony Brook University Medical Center | Stony Brook | New York | 11794 | United States |
| UNC Cancer Hospital Infusion Pharmacy | Chapel Hill | North Carolina | 27514 | United States |
| UNC Hospitals - The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599-7600 | United States |
| Wake Forest Baptist Health | Winston-Salem | North Carolina | 27157 | United States |
| University of Cincinnati Medical Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| OU Medical Center Presbyterian Tower | Oklahoma City | Oklahoma | 73104 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| IDS-investigational drug pharmacy Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Penn State Milton S. Hershey Medical Center, | Hershey | Pennsylvania | 17033 | United States |
| Hollings Cancer Center | Charleston | South Carolina | 29425 | United States |
| MUSC Hospital | Charleston | South Carolina | 29425 | United States |
| Parkland Health and Hospital System | Dallas | Texas | 75235 | United States |
| Baylor Charles A. Sammons Cancer Center | Dallas | Texas | 75246 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |
| University of Texas Southwestern Universtiy Hospital - William P Clements Jr. | Dallas | Texas | 75390 | United States |
| UT Southwestern Medical Center at Dallas | Dallas | Texas | 75390 | United States |
| UT Southwestern University Hospital- Zale Lipshy | Dallas | Texas | 75390 | United States |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| LDS Hospital | Salt Lake City | Utah | 84143 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| West Virginia University Hospitals Pharmaceutical Services | Morgantown | West Virginia | 26506 | United States |
| West Virginia University Hospitals | Morgantown | West Virginia | 26506 | United States |
| Sanatorio Allende | Córdoba | 5000 | Argentina |
| Royal Adelaide Hospital | Adelaide | South Australia | 5000 | Australia |
| Eastern Clinical Research Unit, Box Hill Hospital | Box Hill | Victoria | 3128 | Australia |
| Princess Margaret Cancer Centre | Toronto | Ontario | M5G 2M9 | Canada |
| Guangdong General Hospital | Guangzhou | Guangdong | 510080 | China |
| Henan Cancer Hostipal | Zhengzhou | Henan | 450008 | China |
| The first hospital of jilin university | Changchun | Jilin | 130021 | China |
| Beijing Chao-yang Hospital | Beijing | 100020 | China |
| Peking University People's Hospital | Beijing | 100044 | China |
| The 307th Hospital of PLA | Beijing | 100071 | China |
| Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences, | Tianjin | 300020 | China |
| Interni Hematologicka a Onkologicka Klinika | Brno | 62500 | Czechia |
| Fakultni Nemocnice Hradec Kralove | Hradec Králové | 50005 | Czechia |
| Fakultni nemocnice Kralovske Vinohrady | Prague | 10034 | Czechia |
| HUS-Kuvantaminen | Helsinki | 00290 | Finland |
| HYKS/Hematologian klinikka | Helsinki | 00290 | Finland |
| CHU de Dijon-Hopital d'Enfants-Service d'hematologie Clinique | Dijon | 21000 | France |
| C.H.U. de Grenoble, Hopital Albert Michallon | Grenoble | 38043 | France |
| Hopital Universitaire Andre Mignot | Le Chesnay | 78157 | France |
| CHU Dupuytren | Limoges | 87042 | France |
| Institut Paoli-Calmettes | Marseille | 13009 | France |
| Hôpital Saint-Louis | Paris | 75475 | France |
| Centre Hospitalier Lyon Sud | Pierre-Bénite | 69495 | France |
| Institut de Cancérologie Lucien Neuwirth | Saint-Priest-en-Jarez | 42271 | France |
| Iuct - Oncopole | Toulouse | 31059 | France |
| CHU Brabois- Service d'hematologie | Vandœuvre-lès-Nancy | 54511 | France |
| Zentralapotheke des Universitaetsklinikums Muenster | Münster | North Rhine-Westphalia | 48149 | Germany |
| Universitätsklinikum Köln, Klinik I für Innere Medizin | Cologne | 50937 | Germany |
| Klinikum der Goethe Universitaet | Frankfurt | 60590 | Germany |
| Universitaetsklinikum Heidelberg | Heidelberg | 69120 | Germany |
| Klinikum Rechts der Isar der TU München | München | 81675 | Germany |
| Institut fuer klinische Radiologie | Münster | 48149 | Germany |
| Universitaetsklinikum Muenster | Münster | 48149 | Germany |
| Egyesitett Szent Istvan és Szent Laszlo Korhaz-Rendelointezet; | Budapest | 1097 | Hungary |
| Debreceni Egyetem Orvos-es Egeszsegtudomanyi Centrum II. Belgyogyaszati Klinika | Debrecen | 4032 | Hungary |
| Azienda Ospedaliera Brotzu CTMO P.O. Businco | Cagliari | CA | 09121 | Italy |
| Farmacia | Cagliari | CA | 09121 | Italy |
| U.O. Radiodiagnostica | Cagliari | CA | 09121 | Italy |
| IRST-Ematologia | Meldola (FC) | FC | 47014 | Italy |
| Istituto di Ematologia Seragnoli | Bologna | 40138 | Italy |
| A.O.U. Vittorio Emanuele di Catania-Ospedale Ferrarotto | Catania | 95124 | Italy |
| Radiology (Radiology Only) | Catania | 95124 | Italy |
| U.O. di Ematologia Dip. Medicine Specialistiche A.O.U. Arcispedale Sant'Anna | Cona, Ferrara | 44124 | Italy |
| Clinica Ematologica | Genova | 16132 | Italy |
| Pharmacy | Genova | 16132 | Italy |
| Radiology Department (Radiology ONLY) | Genova | 16132 | Italy |
| Radiology Department | Genova | 16132 | Italy |
| U.O. Ematologia 1 | Genova | 16132 | Italy |
| S.C. Pharmacy | Milan | 20162 | Italy |
| S.C. Radiology | Milan | 20162 | Italy |
| SC Ematologia | Milan | 20162 | Italy |
| A.O. San Gerardo - Farmacia | Monza | 20900 | Italy |
| A.O. San Gerardo di Monza | Monza | 20900 | Italy |
| AORN "A. Cardarelli" | Naples | 80131 | Italy |
| RAdiology Department (RAdiology only) | Naples | 80131 | Italy |
| Clinica Ematologica | Pavia | 27100 | Italy |
| Radiologist Department | Ravenna | 48121 | Italy |
| Servizio di Farmacia | Ravenna | 48121 | Italy |
| U.O. Ematologia, Ospedale S. Maria delle Croci | Ravenna | 48121 | Italy |
| Clinica Ematologica | Udine | 33100 | Italy |
| Radiology (Radiology Only) | Udine | 33100 | Italy |
| Nagoya Daini Red Cross Hospital | Nagoya | Aichi-ken | 4668650 | Japan |
| The Hospital of Hyogo College of Medicine | Nishinomiya-shi | Hyōgo | 6638501 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 9808574 | Japan |
| Osaka City University Hospital | Osaka | Osaka | 5458586 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 1040045 | Japan |
| Akita University Hospital | Akita | 010-8543 | Japan |
| National Hospital Organization Kyushu Cancer Center | Fukuoka | 8111395 | Japan |
| Tokai University Hospital | Kanagawa | 259-1193 | Japan |
| Erasmus Medical Center | Rotterdam | South Holland | 3015 CE | Netherlands |
| Erasmus Medical Center | Rotterdam | South Holland | 3075 EA | Netherlands |
| Klinika Hematologii i Transplantologii | Gdansk | 80-952 | Poland |
| Oddzial Hematologii, Klinika Hematologii, Regionalny Osrodek Onkologiczny Wojewodzki Szpital | Lodz | 93510 | Poland |
| Instytut Hematologii i Transfuzjologii, Klinika Hematologii | Warsaw | 02-776 | Poland |
| Dolnoslaskie Centrum Transplantacji Komorkowych z Krajowym Bankiem Dawcow Szpiku | Wroclaw | 53-439 | Poland |
| National University Hospital/National University Cancer Institute Singapore (NCIS) | Singapore | 119228 | Singapore |
| Singapore General Hospital | Singapore | 169608 | Singapore |
| Chonnam National University, Hwasun Hospital | Hwasun-Gun | Jeollanam-do | 519-763 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| Samsung Medical Center | Seoul | 135 710 | South Korea |
| Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario de Salamanca | Salamanca | Castille and LION | 37007 | Spain |
| Hospital Vall d'Hebron | Barcelona | Catalonia | 08035 | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Mallorca | 07198 | Spain |
| Hospital de la Santa Creu i Sant Pau(Nuevo Hospital) | Barcelona | 08025 | Spain |
| Hospital General Universitario Gregorio Maranon | Madrid | 28007 | Spain |
| Hospital Ramon y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital General Universitario Jose Maria Morales Meseguer | Murcia | 30008 | Spain |
| Hospital Universitario Virgen del Rocio | Seville | 41013 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Universitetssjukhus Lund, Hematologkliniken | Lund | 221 85 | Sweden |
| Hematology Center | Stockholm | 17176 | Sweden |
| Chang Gung Medical Foundation, Kaohsiung Branch | Kaohsiung City | 83301 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Southampton General Hospital | Southampton | Hampshire | SO16 6YD | United Kingdom |
| Bristol Haematology and Oncology Centre | Bristol | BS2 8ED | United Kingdom |
| Castle Hill Hospital | Hull | HU16 5JQ | United Kingdom |
| Department of Academic Oncology | London | NW3 2QG | United Kingdom |
| The Christie NHS Foundation Trust | Manchester | M20 4BX | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Churchill Hospital | Oxford | OX3 7LJ | United Kingdom |
| Derived |
| Stelljes M, Advani AS, DeAngelo DJ, Wang T, Neuhof A, Vandendries E, Kantarjian H, Jabbour E. Time to First Subsequent Salvage Therapy in Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia Treated With Inotuzumab Ozogamicin in the Phase III INO-VATE Trial. Clin Lymphoma Myeloma Leuk. 2022 Sep;22(9):e836-e843. doi: 10.1016/j.clml.2022.04.022. Epub 2022 Apr 27. |
| 35622074 | Derived | Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704. |
| 33602684 | Derived | Kantarjian HM, Stock W, Cassaday RD, DeAngelo DJ, Jabbour E, O'Brien SM, Stelljes M, Wang T, Paccagnella ML, Nguyen K, Sleight B, Vandendries E, Neuhof A, Laird AD, Advani AS. Inotuzumab Ozogamicin for Relapsed/Refractory Acute Lymphoblastic Leukemia in the INO-VATE Trial: CD22 Pharmacodynamics, Efficacy, and Safety by Baseline CD22. Clin Cancer Res. 2021 May 15;27(10):2742-2754. doi: 10.1158/1078-0432.CCR-20-2399. Epub 2021 Feb 18. |
| 33231879 | Derived | Stock W, Martinelli G, Stelljes M, DeAngelo DJ, Gokbuget N, Advani AS, O'Brien S, Liedtke M, Merchant AA, Cassaday RD, Wang T, Zhang H, Vandendries E, Jabbour E, Marks DI, Kantarjian HM. Efficacy of inotuzumab ozogamicin in patients with Philadelphia chromosome-positive relapsed/refractory acute lymphoblastic leukemia. Cancer. 2021 Mar 15;127(6):905-913. doi: 10.1002/cncr.33321. Epub 2020 Nov 24. |
| 32769965 | Derived | DeAngelo DJ, Advani AS, Marks DI, Stelljes M, Liedtke M, Stock W, Gokbuget N, Jabbour E, Merchant A, Wang T, Vandendries E, Neuhof A, Kantarjian H, O'Brien S. Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden. Blood Cancer J. 2020 Aug 7;10(8):81. doi: 10.1038/s41408-020-00345-8. |
| 31790983 | Derived | Jabbour E, Gokbuget N, Advani A, Stelljes M, Stock W, Liedtke M, Martinelli G, O'Brien S, Wang T, Laird AD, Vandendries E, Neuhof A, Nguyen K, Dakappagari N, DeAngelo DJ, Kantarjian H. Impact of minimal residual disease status in patients with relapsed/refractory acute lymphoblastic leukemia treated with inotuzumab ozogamicin in the phase III INO-VATE trial. Leuk Res. 2020 Jan;88:106283. doi: 10.1016/j.leukres.2019.106283. Epub 2019 Nov 25. |
| 31655984 | Derived | Fujishima N, Uchida T, Onishi Y, Jung CW, Goh YT, Ando K, Wang MC, Ono C, Matsumizu M, Paccagnella ML, Sleight B, Vandendries E, Fujii Y, Hino M. Inotuzumab ozogamicin versus standard of care in Asian patients with relapsed/refractory acute lymphoblastic leukemia. Int J Hematol. 2019 Dec;110(6):709-722. doi: 10.1007/s12185-019-02749-0. Epub 2019 Nov 13. |
| 30920645 | Derived | Kantarjian HM, DeAngelo DJ, Stelljes M, Liedtke M, Stock W, Gokbuget N, O'Brien SM, Jabbour E, Wang T, Liang White J, Sleight B, Vandendries E, Advani AS. Inotuzumab ozogamicin versus standard of care in relapsed or refractory acute lymphoblastic leukemia: Final report and long-term survival follow-up from the randomized, phase 3 INO-VATE study. Cancer. 2019 Jul 15;125(14):2474-2487. doi: 10.1002/cncr.32116. Epub 2019 Mar 28. |
| 29381191 | Derived | Jabbour EJ, DeAngelo DJ, Stelljes M, Stock W, Liedtke M, Gokbuget N, O'Brien S, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS, Kantarjian HM. Efficacy and safety analysis by age cohort of inotuzumab ozogamicin in patients with relapsed or refractory acute lymphoblastic leukemia enrolled in INO-VATE. Cancer. 2018 Apr 15;124(8):1722-1732. doi: 10.1002/cncr.31249. Epub 2018 Jan 30. |
| 29330398 | Derived | Kebriaei P, Cutler C, de Lima M, Giralt S, Lee SJ, Marks D, Merchant A, Stock W, van Besien K, Stelljes M. Management of important adverse events associated with inotuzumab ozogamicin: expert panel review. Bone Marrow Transplant. 2018 Apr;53(4):449-456. doi: 10.1038/s41409-017-0019-y. Epub 2018 Jan 12. |
| 28687420 | Derived | Kantarjian HM, DeAngelo DJ, Advani AS, Stelljes M, Kebriaei P, Cassaday RD, Merchant AA, Fujishima N, Uchida T, Calbacho M, Ejduk AA, O'Brien SM, Jabbour EJ, Zhang H, Sleight BJ, Vandendries ER, Marks DI. Hepatic adverse event profile of inotuzumab ozogamicin in adult patients with relapsed or refractory acute lymphoblastic leukaemia: results from the open-label, randomised, phase 3 INO-VATE study. Lancet Haematol. 2017 Aug;4(8):e387-e398. doi: 10.1016/S2352-3026(17)30103-5. Epub 2017 Jul 4. |
| 27292104 | Derived | Kantarjian HM, DeAngelo DJ, Stelljes M, Martinelli G, Liedtke M, Stock W, Gokbuget N, O'Brien S, Wang K, Wang T, Paccagnella ML, Sleight B, Vandendries E, Advani AS. Inotuzumab Ozogamicin versus Standard Therapy for Acute Lymphoblastic Leukemia. N Engl J Med. 2016 Aug 25;375(8):740-53. doi: 10.1056/NEJMoa1509277. Epub 2016 Jun 12. |
| FG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Inotuzumab Ozogamicin | Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status). |
| BG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC) | CR was the disappearance of leukemia indicated by less than (<) 5 percent (%) marrow blasts & absence of peripheral blood leukemic blasts, with recovery of hematopoiesis defined by absolute neutrophil count (ANC) greater than or equal to (≥)1000 per microliter (/μL) & platelets ≥100,000/μL. C1 extramedullary disease status (i.e. complete disappearance of measurable & non-measurable extramedullary disease with the following exceptions: for participants with at least 1 measurable lesion, all nodal masses greater than (>) 1.5 centimeters (cm) in greatest transverse diameter (GTD) at baseline must have regressed to less than or equal to (≤) 1.5 cm in GTD; all nodal masses ≥1 cm & ≤1.5 cm in GTD at baseline must have regressed to <1 cm GTD or reduced by 75% in sum of products of greatest diameters, no new lesions, spleen & other previously enlarged organs must have regressed in size & must not be palpable) was required. CRi was defined as CR except ANC <1000/μL &/or platelets <100,000/μL. | ITT218 population - included the ITT population (all participants randomized) for the initial 218 participants. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Screening, Day 16 to 28 of Cycles 1, 2 and 3, then every 1 to 2 cycles (or as clinically indicated) up to approximately 4 weeks (end of treatment [EoT]) from the last dose |
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| Primary | Overall Survival (OS) | OS was defined as the time from randomization to date of death due to any cause. Participants last known to be alive were censored at date of last contact. | ITT population - included all participants randomized. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Posted | Median | 95% Confidence Interval | Months | Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first. |
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| Secondary | Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment) | DoR was defined as time from date of first response in responders (CR/CRi per Investigator assessment) to date of PFS event (i.e. death, progressive disease [objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status] or starting new induction therapy or post-therapy stem cell transplant [SCT] without achieving CR/CRi). Responders without PFS events were censored at the last valid disease assessment including follow-up. | Participants in the ITT218 population who achieved CR/CRi | Posted | Median | 95% Confidence Interval | Months | Up to 2 years from randomization |
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| Secondary | Progression-Free Survival (PFS) | PFS was defined as time from date of randomization to earliest date of the following events: death, progressive disease (objective progression, relapse from CR/CRi or treatment discontinuation due to global deterioration of health status) and starting new induction therapy or post-therapy SCT without achieving CR/CRi. Participants without a PFS event at time of analysis were censored at the last valid disease assessment. In addition, participants with documentation of an event after an unacceptably long interval (>28 weeks if there was post-baseline disease assessment, or >12 weeks if there was no post-baseline assessment) since the previous disease assessment were censored at the time of the previous assessment (date of randomization if no post-baseline assessment). Post-study treatment follow-up disease assessments was included. Kaplan-Meier method used and 2-sided 95% confidence interval (CI) calculated based on the Brookmeyer and Crowley method. | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Posted | Median | 95% Confidence Interval | Months | Up to 2 years from randomization |
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| Secondary | Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT) | HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy. | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to 19 weeks from last dose |
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| Secondary | Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment) | MRD analysis was performed at least once in participants with prior assessment of CR or CRi. Bone marrow aspirates, collected at screening and during the study, were sent to the central laboratory and analyzed using multiparametric flow cytometry. The antibody combinations were designed to maximize discrimination between normal and abnormal cells of B-cell lineage and similar maturational stage and included antibodies detecting cluster of differentiation (CD) 9, CD10, CD13, CD19, CD20, CD33, CD34, CD38, CD45, CD58, CD66c, and CD123. A peripheral blood sample was provided if a participant had an inadequate bone marrow aspirate at screening. MRD negativity was considered to have been achieved if the lowest value of MRD from the first date of CR/CRi to EoT was <1 × 10^-4 blasts/nucleated cells. | Participants in the ITT218 population achieving CR/CRi (per EAC Assessment) | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 4 weeks (EoT) from last dose of study drug |
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| Secondary | Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment) | Karyotyping was required locally, at screening and at least once during the study in participants who had abnormal cytogenetics at baseline and who achieved CR/CRi. Data presented below are for participants who achieved CR/CRi per EAC and had abnormal karyotype at screening. | Participants in the ITT218 population who had abnormal cytogenetics at baseline and who achieved CR/CRi | Posted | Number | 95% Confidence Interval | Percentage of Participants | Up to approximately 4 weeks (EoT) from last dose of study drug |
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| Secondary | Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing | Blood samples were collected and analyzed for inotuzumab ozogamicin serum concentrations using a validated high performance liquid chromatography with tandem mass spectrometry (HPLC/MS/MS) method with a lower limit of quantification of 1.0 nanograms per milliliter (ng/mL). Cmax was the maximum observed concentration occurring between 0-8 hours post-dose. Ctrough was the concentration prior to subsequent dose (pre-dose) occurring after 8 hours. n = number of observations (non-missing concentrations). | Pharmacokinetic (PK) evaluable population - included all participants with available PK data. | Posted | Mean | Standard Deviation | ng/mL | Days 1, 4, 8, and 15 of Cycle 1, Days 1 and 8 of Cycle 2 and Day 1 of Cycle 4 |
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| Secondary | Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score | This questionnaire comprised 30 questions within which are 9 multi-item scales & 6 single-item measures. There are 5 functional scales; physical, role, cognitive, emotional & social, 3 symptom scales; fatigue, pain, & nausea & vomiting, & a global health status/quality of life (QoL) scale. There are 5 single item measures assessing additional symptoms commonly reported by cancer patients (loss of appetite, insomnia, constipation, diarrhea, & dyspnea) & a single item concerning perceived financial impact of the disease. Most questions used a 4 point scale (1='not at all' to 4='very much'); 2 questions used a 7-point scale (1='very poor' to 7='excellent'). Scores were averaged & transformed to a scale ranging from 0 to 100; a higher score indicates a better level of functioning or greater degree of symptoms. | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population | Posted | Mean | Standard Error | Score on a scale | Day 1 of each cycle prior to dosing and EoT |
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| Secondary | Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score | The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. EQ-5D summary index is obtained with a formula that weights each level of the dimensions. The index-based score is interpreted along a continuum of 0 (death) to 1 (perfect health). | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Posted | Mean | Standard Error | Score on a scale | Day 1 of each cycle prior to dosing and EoT |
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| Secondary | Change From Baseline in EQ-5D VAS | The EQ-5D self-report questionnaire is a standardized measure of health status developed by the EuroQoL Group. It consists of the EQ-5D descriptive system and a visual analogue scale (VAS), EQ-VAS. The EQ-5D descriptive system measures a participants' health state on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 3 levels, reflecting "no problems", "some problems", and "extreme problems". The EQ-VAS records the respondent's self-rated health on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. | ITT population. Although only 143 participants were treated in the Defined Investigator's Choice of Chemotherapy arm, all 162 randomized participants were included in the ITT population. | Posted | Mean | Standard Error | Score on a scale | Day 1 of each cycle prior to dosing and EoT |
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| Secondary | Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT | VOD/SOS was defined as the occurrence of 2 out of the following 3 clinical criteria: 1) total serum bilirubin level >34 micromoles per liter (μmol/L) (>2.0 milligrams per deciliter [mg/dL]), 2) an increase in liver size from baseline or development of right upper quadrant pain of liver origin and 3) sudden weight gain >2.5% (eg, within a 72 hour period) because of fluid accumulation in the weeks following infusion of study drug or chemotherapy, or HSCT conditioning/preparative therapy, or development of ascites not present at baseline following such exposures AND the absence of other explanations for these signs and symptoms, OR development of bilirubin elevation, weight gain, or hepatomegaly plus histologic abnormalities on liver biopsy demonstrating hepatocyte necrosis in zone 3 of the liver acinus, sinusoidal fibrosis, and centrilobular hemorrhage, with or without fibrosis of the terminal hepatic venules. | Participants in the Safety population with post-study HSCT. A site visit in July 2017 (after clinical database lock), confirmed a fourth case of VOD/SOS occurred in the Defined Investigators Choice of Chemotherapy arm in March 2013 (approximately 3 months after the last dose).This was not entered on the CRF and therefore, is not included below. | Posted | Number | Percentage of Participants | Up to 2 years from randomization |
|
SAEs and non-serious AEs are summarized from Cycle 1 Day 1 up to 42 days after last dose, or any time after Cycle 1 Day1 (treatment-related).
An event may appear as both an AE & SAE. However, what is presented are distinct events. An event may be categorized as serious in 1 participant & non-serious in another participant, or 1 participant may have experienced both a serious & non-serious event. Events were reported up to at least 28 days after last dose.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Inotuzumab Ozogamicin | Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m^2 (for a total cycle dose of 1.5 mg/m^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status). | 85 | 164 | 159 | 164 | ||
| EG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. | 72 | 143 | 143 | 143 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Pancytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
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| Acute coronary syndrome | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Cardiac arrest | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Left ventricular dysfunction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Pericarditis | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
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| Blindness unilateral | Eye disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Ascites | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Colitis ischaemic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Dysphagia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Gastritis haemorrhagic | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Ileal perforation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Intestinal ischaemia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Intra-abdominal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Large intestinal ulcer | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Mesenteric haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Proctalgia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
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| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Disease progression | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Mucosal inflammation | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Multiple organ dysfunction syndrome | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
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| Cholecystitis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Hepatic vein thrombosis | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
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| Venoocclusive liver disease | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment | After clinical database lock, a fourth case of VOD/SOS was confirmed in the Defined Investigators Choice of Chemotherapy arm in March 2013 (approximately 3 months after last dose). This was not entered on the CRF and therefore, is not included below. |
|
| Adenoviral upper respiratory infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Bacterial infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Brain abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Bronchopulmonary aspergillosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Candida infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Clostridium difficile colitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Clostridium difficile infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Corona virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Cytomegalovirus chorioretinitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Device related infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Enteritis necroticans | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
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| Enterococcal bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Enterococcal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Escherichia bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Escherichia sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fungaemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fungal infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Klebsiella bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Klebsiella infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Liver abscess | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Lung infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Necrotising fasciitis fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenic sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Parainfluenzae virus infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia pseudomonal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pseudomonal bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pseudomonal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic embolus | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Serratia bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Staphylococcal sepsis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Systemic candida | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Systemic mycosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Urinary tract infection fungal | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Subdural haematoma | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lactic acidosis | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tumour lysis syndrome | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bone infarction | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nervous system disorder | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pharyngeal stenosis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Respiratory tract oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Shock haemorrhagic | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombophlebitis | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mucormycosis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Mucosal inflammation | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 18.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 18.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA 18.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Fluid overload | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 18.1 | Systematic Assessment |
|
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. Investigators will, on request, remove any previously undisclosed Confidential Information (other than the Study results themselves) before disclosure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000080045 | Inotuzumab Ozogamicin |
| C024352 | fludarabine |
| D003561 | Cytarabine |
| D016179 | Granulocyte Colony-Stimulating Factor |
| D008942 | Mitoxantrone |
| ID | Term |
|---|---|
| D000080084 | Calicheamicins |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001087 | Arabinonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D003115 | Colony-Stimulating Factors |
| D006023 | Glycoproteins |
| D006001 | Glycoconjugates |
| D016298 | Hematopoietic Cell Growth Factors |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D001685 | Biological Factors |
| D000880 | Anthraquinones |
| D000095322 | Anthrones |
| D000873 | Anthracenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011809 | Quinones |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
| OG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
| OG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
| OG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
| Defined Investigator's Choice of Chemotherapy |
Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
|
|
| OG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
| OG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
| OG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|
|
| OG001 | Defined Investigator's Choice of Chemotherapy | Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice. |
|
|