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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04666038
Registration number
NCT04666038
Ethics application status
Date submitted
7/12/2020
Date registered
14/12/2020
Date last updated
20/04/2025
Titles & IDs
Public title
Study of LOXO-305 (Pirtobrutinib) Versus Investigator's Choice (Idelalisib Plus Rituximab or Bendamustine Plus Rituximab) in Patients With Previously Treated Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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Scientific title
A Phase 3 Open-Label, Randomized Study of LOXO-305 Versus Investigator's Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab in BTK Inhibitor Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-321)
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Secondary ID [1]
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0
J2N-OX-JZNN
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Secondary ID [2]
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18073
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Universal Trial Number (UTN)
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Trial acronym
BRUIN CLL-321
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
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Small Lymphocytic Lymphoma
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Condition category
Condition code
Cancer
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Pirtobrutinib
Treatment: Drugs - Idelalisib
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab
Experimental: Arm A - Pirtobrutinib - Participants received 200 milligrams (mg) of pirtobrutinib administered orally once daily (QD) on Days 1 through 28 of a 28-day cycle. The treatment was continued until progressive disease, a discontinuation criterion, or unacceptable toxicity.
Active comparator: Arm B - Idelalisib plus Rituximab or Bendamustine plus Rituximab - Participants received either 150 mg of idelalisib administered twice-daily (BID) orally on Days 1 through 28 of a 28-day cycle in combination with 375 milligram per square meter (mg/m\^2) of rituximab by intravenous (IV) infusion on day 1 of cycle 1, then 4 IV infusions of rituximab 500 mg/m\^2 every 2 weeks (Q2W) and 3 IV infusions of rituximab 500 mg/m\^2 every 4 weeks (Q4W) or 70 mg/m\^2 of bendamustine administered IV on day 1 and 2 of each 28-day cycle from cycles 1 to 6 in combination with 375 mg/m\^2 of rituximab IV on day 1 of cycle 1, then 500 mg/m\^2 of rituximab on day 1 of each 28-day cycle from cycles 2 to 6.
Treatment: Drugs: Pirtobrutinib
Oral Pirtobrutinib
Treatment: Drugs: Idelalisib
Oral
Treatment: Drugs: Bendamustine
IV
Treatment: Drugs: Rituximab
IV
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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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Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
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Assessment method [1]
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PFS is defined as the time from the date of randomization to the date of first documentation of progressive disease (PD) or death from any cause, as evaluated by an IRC according to International Workshop on Chronic Lymphocytic Leukemia (iwCLL) 2018.
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Timepoint [1]
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Randomization to Disease Progression or Death Due to Any Cause (Up to 29 Months)
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Secondary outcome [1]
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PFS Assessed by Investigator
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Assessment method [1]
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PFS is defined as time from the date of randomization to the date of first documentation of PD or death from any cause, as evaluated by an investigator according to iwCLL 2018.
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Timepoint [1]
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Randomization to Disease Progression or Death Due to Any Cause (Up to 36 Months)
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS was defined as time from randomization to death due to any cause.
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Timepoint [2]
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Randomization to Death from Any Cause (Up to 36 months)
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Secondary outcome [3]
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Time to Next Treatment (TTNT)
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Assessment method [3]
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TTNT was defined as time from the date of randomization to the date of initiation of the subsequent anticancer therapy for chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), therapy of pirtobrutinib for Arm B patients, or death due to any cause, whichever occurs first.
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Timepoint [3]
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Randomization to Subsequent Anticancer Therapy, Therapy of Pirtobrutinib or Death Due to Any Cause (Up to 36 Months)
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Secondary outcome [4]
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Event Free Survival (EFS)
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Assessment method [4]
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EFS is defined as the time from randomization to the first occurrence of: * Documented disease progression per iwCLL 2018 criteria as assessed by Investigator; or * Initiation of subsequent anticancer therapy for CLL/SLL; or * Unacceptable toxicity leading to treatment discontinuation as assessed by the Investigator; or * Death (due to any cause).
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Timepoint [4]
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Randomization to Disease Progression, Subsequent Anticancer Therapy, Unacceptable Toxicity Leading to Treatment Discontinuation, or Death Due to Any Cause (Up to 36 Months)
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Secondary outcome [5]
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Percentage of Participants With Overall Response Rate (ORR) Assessed by Investigator
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Assessment method [5]
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ORR according to investigator-assessed best overall response (BOR) based on iwCLL 2018 is defined as the number of participants who achieve a BOR of complete response (CR), complete response with incomplete bone marrow recovery (CRi), nodular partial response (nPR) or partial response (PR) at or before the initiation of subsequent anticancer therapy divided by the total number of participants randomized to each treatment arm.
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Timepoint [5]
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Randomization to Subsequent Anticancer Therapy, Disease Progression or Death Due to Any Cause (Up to 36 Months)
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Secondary outcome [6]
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Time to Worsening (TTW) of CLL/SLL Related Symptoms
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Assessment method [6]
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TTW was defined as a change in score greater than the meaningful within-person change for worsening in score. Scores were furthermore required to be sustained. To meet the requirement for sustained change, the assessment following the first observation of a meaningful worsening of the score (event date) was also required to show a meaningful worsening compared to baseline. The event date was defined as the first of these consecutive events. The European Organization for Research and Treatment of Cancer Item Library 87 was used, which is scored from 0-100, with higher scores reflecting more symptoms. The time to sustained patient-reported outcome (PRO) deterioration was calculated using all on-treatment assessment time points up to the Week 25 (Arm A \& Arm B - Idelalisib plus Rituximab) and up to Week 21 + Safety follow-up of up to 5 weeks (Arm B - Bendamustine plus Rituximab) assessment time point prior to disease progression.
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Timepoint [6]
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Baseline up to Week 25 (Arm A and Arm B - Idelalisib plus Rituximab) & Baseline up to Week 21 + Safety Follow-Up of up to 5 Weeks (Arm B - Bendamustine plus Rituximab)
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Secondary outcome [7]
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Time to Worsening (TTW) of Physical Function
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Assessment method [7]
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0
Time of worsening was defined as a change in score greater than the meaningful within-person change for worsening in score. Scores were furthermore required to be sustained. To meet the requirement for sustained change, the assessment following the first observation of a meaningful worsening of the score (event date) was also required to show a meaningful worsening compared to baseline. The event date was defined as the first of these consecutive events. The European Organization for Research and Treatment of Cancer Item Library 87 was used, which is scored from 0-100, with higher scores reflecting more symptoms. The time to sustained PRO deterioration was calculated using all on-treatment assessment time points up to the Week 25 (Arm A and IdelaR) and up to Week 21 + Safety follow-up (BR) assessment time point prior to disease progression.
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Timepoint [7]
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Baseline up to Week 25 (Arm A and Arm B - Idelalisib plus Rituximab) & Baseline up to Week 21 + Safety Follow-Up of up to 5 Weeks (Arm B - Bendamustine plus Rituximab)
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Eligibility
Key inclusion criteria
* Confirmed diagnosis of CLL/SLL requiring therapy as defined by iwCLL 2018 criteria.
* Previously treated with a covalent BTK inhibitor.
* Eastern Cooperative Oncology Group (ECOG) 0-2.
* Absolute neutrophil count = 0.75 × 10^9/L without granulocyte-colony-stimulating factor support, or = 0.50 × 10^9/L in patients with documented bone marrow involvement considered to impair hematopoiesis. Granulocyte-colony-stimulating factor support is permitted in patients with documented bone marrow involvement.
* Hemoglobin = 8 g/dL or = 6 g/dL in patients with documented bone marrow involvement considered to impair hematopoiesis. Transfusion support is permitted in patients with bone marrow involvement.
* Platelets = 50 × 10^9/L. If an investigator has chosen bendamustine/rituximab as the Arm B treatment, platelets must be = 75 × 10^9/L. Patients may enroll below these thresholds if the Investigator determines the cytopenia is related to bone marrow involvement considered to impair hematopoiesis. Patients with a platelet count < 30 x 10^9/L are excluded.
* AST and ALT = 3.0 x upper limit of normal (ULN).
* Total bilirubin = 1.5 x ULN.
* Estimated creatinine clearance of = 30 mL/min.
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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
* Known or suspected Richter's transformation at any time preceding enrollment.
* Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.
* Ongoing drug-induced liver injury.
* Active uncontrolled auto-immune cytopenia.
* Significant cardiovascular disease.
* History of allogeneic or stem cell transplantation (SCT) or chimeric antigen receptor-modified T cells (CAR-T) therapy within the past 60 days.
* Active hepatitis B or hepatitis C.
* Known active cytomegalovirus (CMV) infection.
* Active uncontrolled systemic bacterial, viral, fungal or parasitic infection.
* Known Human Immunodeficiency Virus (HIV) infection, regardless of CD4 count.
* Clinically significant active malabsorption syndrome or inflammatory bowel disease
* Prior exposure to non-covalent (reversible) BTK inhibitor.
* Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist.
* Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers.
* Vaccination with a live vaccine within 28 days prior to randomization.
* Patients with the following hypersensitivity:
1. Known hypersensitivity, including anaphylaxis, to any component or excipient of LOXO-305. For patients planned to receive idelalisib, known hypersensitivity, including anaphylaxis, to any component or excipient of idelalisib. For patients planned to receive bendamustine, known hypersensitivity, including anaphylaxis, to any component or excipient of bendamustine.
2. Prior significant hypersensitivity to rituximab.
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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
Active, not recruiting
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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
9/03/2021
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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
1/05/2027
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Actual
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Sample size
Target
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Accrual to date
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Final
238
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,VIC,WA
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Recruitment hospital [1]
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Canberra Hospital - Garran
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St Vincent's Hospital - Darlinghurst
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The St. George Hospital - Kogarah
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Ingham Institute of Medical Research - Liverpool
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Westmead Hospital - Wentworthville
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The Alfred Hospital - Melbourne
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2605 - Garran
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Recruitment postcode(s) [2]
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2010 - Darlinghurst
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2217 - Kogarah
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NSW2170 - Liverpool
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2145 - Wentworthville
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3004 - Melbourne
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Recruitment postcode(s) [7]
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6000 - Perth
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Recruitment outside Australia
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Brno
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Praha 2
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La Roche Sur Yon
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Politiers
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Germany
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Baden-Württemberg
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Köln
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Mainz
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Germany
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München
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Budapest
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Debrecen
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Nyiregyhaza
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Hungary
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Pecs
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Ireland
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Dublin 7
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Ireland
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Dublin 8
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Ireland
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Dublin
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HaMerkaz
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Israel
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Beer Sheva
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Israel
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Netanya
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Israel
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Tel Aviv
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Israel
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?eifa
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Italy
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Bari
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Italy
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Piano 2
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Italy
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PI
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Italy
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Potenza
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Country [91]
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Italy
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State/province [91]
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Veneto
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Italy
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Alessandria
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Italy
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Bergamo
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Italy
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Brescia
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Italy
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Catania
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Italy
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Catanzaro
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Italy
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Firenze
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Italy
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Genova
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Italy
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Messina
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Italy
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Milano
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Italy
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Modena
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Italy
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Pavia
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Italy
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Perugia
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Italy
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Ravenna
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Italy
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Roma
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Italy
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Terni
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Country [107]
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Italy
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Torino
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Country [108]
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Italy
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State/province [108]
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Tricase
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Country [109]
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Italy
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Trieste
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Country [110]
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Italy
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Verona
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Country [111]
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Japan
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Aichi
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Country [112]
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Japan
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Gifu
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Japan
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Hokkaido
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Japan
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Hyogo
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Japan
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Kanagawa
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Japan
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Kochi
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Japan
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Miyagi-Ken
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Japan
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Miyagi
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Tokyo
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Japan
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Fukoka-ken
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Japan
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Kumamoto
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Japan
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Okayama
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Korea, Republic of
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Incheon-gwangyeoksi [Incheon]
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Korea, Republic of
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Pusan-Kwangyokshi
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Korea, Republic of
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Seoul, Korea
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Korea, Republic of
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Seoul-teukbyeolsi [Seoul]
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Korea, Republic of
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Seoul
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Korea, Republic of
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Busan
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Poland
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Legnica
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Lubelskie
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Pomorskie
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Poland
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Brzozów
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Bydgoszcz
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Poland
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Katowice
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Poland
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Krakow
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Poland
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Walbrzych
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Poland
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Warszawa
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Poland
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Wroclaw
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Poland
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Lódz
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Russian Federation
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Omskaya Oblast'
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Russian Federation
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Saint Petersburg
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Russian Federation
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Sochi
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Singapore
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Central Singapore
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Spain
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Barcelona
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Spain
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Castilla La Mancha
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Spain
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La Coruna
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Spain
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Madrid, Comunidad De
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Spain
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Madrid
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Spain
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Planta Baja
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Spain
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Albacete
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Spain
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Caceres
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Vitoria
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Switzerland
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Svizzera
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Taipei City
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Taiwan
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Taoyuan, (r.o.c.)
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Turkey
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Ankara
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Turkey
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Istanbul
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Country [164]
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Turkey
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Melikgazi
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Turkey
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Yenimahalle
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Turkey
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Izmir
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United Kingdom
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Aberdeen City
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United Kingdom
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Cornwall
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United Kingdom
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Devon
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United Kingdom
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East Yorkshire
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United Kingdom
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Greater London
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Norfolk
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United Kingdom
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Sa2 8qa
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United Kingdom
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Scotland
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United Kingdom
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Surrey
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United Kingdom
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West Lothian
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United Kingdom
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Leeds
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United Kingdom
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Milton Keynes
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United Kingdom
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Newmarket
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Loxo Oncology, Inc.
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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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Eli Lilly and Company
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a study for patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have previously received treatment with at least a BTK inhibitor. The main purpose is to compare LOXO-305 to idelalisib plus rituximab or bendamustine plus rituximab. Participation could last up to four years, and possibly longer, if the disease does not progress.
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Trial website
https://clinicaltrials.gov/study/NCT04666038
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Marisa Hill, MD
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Address
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0
Loxo Oncology, Inc.
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0
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/38/NCT04666038/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/38/NCT04666038/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT04666038
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