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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01564784
Registration number
NCT01564784
Ethics application status
Date submitted
26/03/2012
Date registered
28/03/2012
Date last updated
9/01/2019
Titles & IDs
Public title
A Study Of Inotuzumab Ozogamicin Versus Investigator's Choice Of Chemotherapy In Patients With Relapsed Or Refractory Acute Lymphoblastic Leukemia
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Scientific 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)
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Secondary ID [1]
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2011-005491-41
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Secondary ID [2]
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B1931022
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Acute Lymphoblastic Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - inotuzumab ozogamicin
Treatment: Drugs - FLAG (fludarabine, cytarabine and G-CSF)
Treatment: Drugs - HIDAC (high dose cytarabine)
Treatment: Drugs - cytarabine and mitoxantrone
Experimental: Arm A -
Active Comparator: Arm B -
Treatment: Drugs: 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
Treatment: Drugs: 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
Treatment: Drugs: HIDAC (high dose cytarabine)
cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants With Hematologic Remission (Complete Remission [CR]/Complete Remission With Incomplete Hematologic Recovery [CRi]) as Assessed by the Endpoint Adjudication Committee (EAC)
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Assessment method [1]
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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.
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Timepoint [1]
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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 outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 5 years after randomization or 2 years from randomization of the last participant, whichever occurs first.
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Secondary outcome [1]
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Duration of Remission (DoR) for Participants Who Achieved CR/CRi (Per Investigator Assessment)
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Assessment method [1]
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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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Timepoint [1]
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Up to 2 years from randomization
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Secondary outcome [2]
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Progression-Free Survival (PFS)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 2 years from randomization
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Secondary outcome [3]
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Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)
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Assessment method [3]
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HSCT rate was defined as the percentage of participants who underwent SCT following treatment with inotuzumab ozogamicin or Investigator's choice of chemotherapy.
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Timepoint [3]
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Up to 19 weeks from last dose
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Secondary outcome [4]
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Percentage of Participants Achieving MRD Negativity (Based on Central Laboratory Analysis) in Participants Achieving a CR/CRi (Per EAC Assessment)
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Assessment method [4]
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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.
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Timepoint [4]
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Up to approximately 4 weeks (EoT) from last dose of study drug
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Secondary outcome [5]
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Cytogenetic Status (Based on Local Laboratory Analysis) of Participants With CR/CRi (Per EAC Assessment)
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Assessment method [5]
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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.
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Timepoint [5]
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Up to approximately 4 weeks (EoT) from last dose of study drug
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Secondary outcome [6]
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Maximum Observed Inotuzumab Ozogamicin Serum Concentration (Cmax) and Pre-Dose Inotuzumab Ozogamicin Serum Concentration (Ctrough) Following Single and Multiple Dosing
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Assessment method [6]
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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).
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Timepoint [6]
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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 outcome [7]
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Change From Baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Core 30 (EORTC QLQ-C30) Score
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Assessment method [7]
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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.
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Timepoint [7]
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Day 1 of each cycle prior to dosing and EoT
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Secondary outcome [8]
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Change From Baseline in EuroQol 5 Dimension Health Questionnaire (EQ-5D) Index Score
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Assessment method [8]
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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).
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Timepoint [8]
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Day 1 of each cycle prior to dosing and EoT
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Secondary outcome [9]
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Change From Baseline in EQ-5D VAS
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Assessment method [9]
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0
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.
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Timepoint [9]
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Day 1 of each cycle prior to dosing and EoT
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Secondary outcome [10]
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Percentage of Participants With Veno-Occlusive Liver Disease (VOD)/Sinusoidal Obstruction Syndrome (SOS) Following Post Study HSCT
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Assessment method [10]
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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.
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Timepoint [10]
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Up to 2 years from randomization
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Eligibility
Key inclusion criteria
- CD22 expression
- Adequate liver and renal functions
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Isolated extramedullary disease
- Active Central Nervous System [CNS] disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/08/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/01/2017
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Sample size
Target
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Accrual to date
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Final
326
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [2]
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Eastern Clinical Research Unit, Box Hill Hospital - Box Hill
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment outside Australia
Country [1]
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0
United States of America
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California
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0
United States of America
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0
Colorado
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0
United States of America
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Connecticut
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Iowa
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Maryland
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United States of America
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Massachusetts
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United States of America
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Michigan
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New Jersey
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New Mexico
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Oklahoma
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Pennsylvania
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South Carolina
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Texas
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Utah
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Washington
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United States of America
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West Virginia
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Argentina
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Cordoba
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Canada
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Ontario
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China
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Guangdong
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China
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Henan
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China
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Jilin
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China
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Beijing
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China
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Tianjin
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Czechia
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Brno
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Czechia
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Hradec Kralove
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Czechia
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Praha 10
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Finland
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Helsinki
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France
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Dijon
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France
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Grenoble Cedex 09
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France
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Le Chesnay Cedex
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France
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Limoges Cedex
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France
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Marseille
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France
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Paris Cedex 10
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France
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Pierre Benite Cedex
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France
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Saint Priest en Jarez Cedex
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France
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Toulouse Cedex 9
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France
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Vandoeuvre-les-Nancy
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Germany
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Nordrhein-westfalen
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Germany
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Frankfurt
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Germany
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Heidelberg
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Germany
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Köln
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Germany
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Muenchen
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Germany
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Muenster
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Hungary
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Budapest
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Hungary
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Debrecen
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Italy
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CA
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0
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Italy
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FC
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0
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Italy
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Bologna
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Italy
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Catania
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Italy
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Cona, Ferrara
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Italy
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Genova
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0
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Italy
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Milano
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Italy
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Monza
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Italy
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Napoli
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Italy
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Pavia
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Italy
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Ravenna
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Italy
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Udine
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Japan
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Aichi
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Japan
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Hyogo
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Japan
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Miyagi
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0
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Japan
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Osaka
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0
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Japan
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Tokyo
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0
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Japan
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0
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Akita
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0
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Japan
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Fukuoka
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0
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Japan
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Kanagawa
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Korea, Republic of
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Jeonnam
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Korea, Republic of
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Seoul
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0
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Netherlands
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South Holland
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0
0
Poland
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0
Gdansk
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0
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Poland
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Lodz
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0
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Poland
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0
0
Warsaw
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0
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Poland
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Wroclaw
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0
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Singapore
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0
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Singapore
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0
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Spain
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State/province [82]
0
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Barcelona
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Country [83]
0
0
Spain
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State/province [83]
0
0
Castille AND LION
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Country [84]
0
0
Spain
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State/province [84]
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0
Catalonia
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Country [85]
0
0
Spain
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State/province [85]
0
0
Mallorca
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Country [86]
0
0
Spain
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State/province [86]
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0
Madrid
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Country [87]
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0
Spain
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State/province [87]
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0
Murcia
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Country [88]
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0
Spain
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State/province [88]
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0
Sevilla
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Country [89]
0
0
Spain
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State/province [89]
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0
Valencia
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Country [90]
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0
Sweden
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State/province [90]
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0
Lund
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Country [91]
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0
Sweden
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State/province [91]
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0
Stockholm
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Country [92]
0
0
Taiwan
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State/province [92]
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0
Kaohsiung
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Country [93]
0
0
Taiwan
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State/province [93]
0
0
Taipei
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Country [94]
0
0
United Kingdom
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State/province [94]
0
0
Hampshire
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Country [95]
0
0
United Kingdom
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State/province [95]
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0
Bristol
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Country [96]
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0
United Kingdom
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State/province [96]
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0
Hull
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Country [97]
0
0
United Kingdom
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State/province [97]
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0
London
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Country [98]
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0
United Kingdom
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State/province [98]
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0
Manchester
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Country [99]
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0
United Kingdom
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State/province [99]
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0
Nottingham
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Country [100]
0
0
United Kingdom
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State/province [100]
0
0
Oxford
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
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0
UCB Pharma
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Address [1]
0
0
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Country [1]
0
0
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Ethics approval
Ethics application status
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Summary
Brief summary
This study will compare the efficacy, in terms of complete responses and overall survival, of
inotuzumab ozogamicin versus investigator's choice of chemotherapy.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01564784
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Pfizer CT.gov Call Center
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Address
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Pfizer
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for public queries
Name
0
0
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Address
0
0
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Country
0
0
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Phone
0
0
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Fax
0
0
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Email
0
0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01564784
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