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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/NCT03590171
Registration number
NCT03590171
Ethics application status
Date submitted
23/05/2018
Date registered
18/07/2018
Date last updated
9/02/2024
Titles & IDs
Public title
International Study for Treatment of High Risk Childhood Relapsed ALL 2010
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Scientific title
International Study for Treatment of High Risk Childhood Relapsed ALL 2010 A Randomized Phase II Study Conducted by the Resistant Disease Committee of the International Berlin, Frankfurt, Münster (BFM) Study Group
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Secondary ID [1]
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IntReALL HR 2010
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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 (ALL)
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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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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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bortezomib
No Intervention: Arm HR-A - Induction: Backbone ALL R3
Experimental: Arm HR-B - Induction: Backbone ALL R3 + Bortezomib
Treatment: Drugs: Bortezomib
Patients randomised to the HR-B arm receive induction, consolidation with the modified ALL R3 protocol. In this arm, patients are randomized to receive Bortezomib together with the ALL R3 protocol during induction. Administration of Bortezomib: 1.3 mg/m2 as intravenous bolus or subcutaneously (SC, at the discretion of the treating physician) on days 1 and 4 of weeks 1 and 3.
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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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Rate of Complete Remission
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Assessment method [1]
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Rate of complete second remission (CR2) quantified by cytology after induction with standard chemotherapy + bortezomib (arm B) compared with standard chemotherapy (arm A).
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Timepoint [1]
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Week 4
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Secondary outcome [1]
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Event-free Survival
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Assessment method [1]
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Improvement of three years event-free survival (EFS)
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Timepoint [1]
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Year 3
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Secondary outcome [2]
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Overall Survival
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Assessment method [2]
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Improvement of three years overall survival (OS)
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Timepoint [2]
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Year 3
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Secondary outcome [3]
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Minimal Residual Disease Reduction (MRD)
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Assessment method [3]
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Improvement of Minimal Residual Disease (MRD) reduction after induction with versus without bortezomib
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Timepoint [3]
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Week 4
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Secondary outcome [4]
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Minimal Residual Disease Load
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Assessment method [4]
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Improvement of MRD load prior to stem cell transplantation (SCT).
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Timepoint [4]
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Week 15
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Secondary outcome [5]
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Minimal Residual Disease (MRD)
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Assessment method [5]
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Prognostic relevance of MRD pre stem cell transplantation (SCT). MRD will be quantified before stem cell transplantation with polymerase chain reaction (PCR) and will be related to EFS after SCT. Multicolour flow cytometry will be used in parallel with PCR. Flow cytometry is used instead of PCR if PCR based MRD-quantification cannot be performed, because criteria for a reliable and reproducible sensitive quantification are not fulfilled.
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Timepoint [5]
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Week 15
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Secondary outcome [6]
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Complete Remission/Minimal Residual Disease Rates During Consolidation
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Assessment method [6]
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Improvement of CR2 and/or MRD rates during consolidation
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Timepoint [6]
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Week 5, 8, 11, 15
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Secondary outcome [7]
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Toxicity of induction classified with the COMMON TOXICITY CRITERIA (CTC)
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Assessment method [7]
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Toxicity of induction with versus without bortezomib. Toxicity of the central nervous system and peripheral neuropathy will be classified with the COMMON TOXICITY CRITERIA (CTC).
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Timepoint [7]
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At induction up to week 5
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Eligibility
Key inclusion criteria
- Morphologically confirmed diagnosis of 1st relapsed precursor B-cell or T-cell ALL
- Children less than 18 years of age at date of inclusion into the study
- Meeting HR criteria any BM relapse, early/very early isolated BM relapse, very early
isolated/combined extramedullary relapse)
- Patient enrolled in a participating centre
- Written informed consent
- Start of treatment falling into the study period
- No participation in other clinical trials 30 day prior to study enrolment that
interfere with this protocol, except trials for primary ALL
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Minimum age
No limit
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Maximum age
17
Years
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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
- Breakpoint cluster region-Abelson (BCR-ABL)/ t(9;22) positive ALL
- Pregnancy or positive pregnancy test (urine sample positive for ß-humane
choriongonadotropin (HCG) > 10 U/l)
- Sexually active adolescents not willing to use highly effective contraceptive method
(pearl index <1) until 12 months after end of anti-leukemic therapy
- Breast feeding
- Relapse post allogeneic stem-cell transplantation
- Neuropathy > II°
- The whole protocol or essential parts are declined either by patient himself/herself
or the respective legal guardian
- Objection to the study participation by a minor patient, able to object
- Any patient being dependent on the investigator
- No consent is given for saving and propagation of pseudonymized medical data for study
reasons
- Severe concomitant disease that does not allow treatment according to the protocol at
the investigator's discretion (e.g. malformation syndromes, cardiac malformations,
metabolic disorders)
- Subjects unwilling or unable to comply with the study procedures
- Subjects who are legally detained in an official institute
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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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
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
1/09/2017
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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
31/12/2027
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Actual
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Sample size
Target
250
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Australian & New Zealand Childhood Hematology & Oncology Group - Clayton
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment outside Australia
Country [1]
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Austria
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State/province [1]
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Vienna
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Belgium
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State/province [2]
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Bruxelles
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Czechia
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Prague
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Denmark
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Copenhagen
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Finland
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Turku
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France
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State/province [6]
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Nice
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Israel
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State/province [7]
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Tel Aviv
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Italy
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State/province [8]
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Roma
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Netherlands
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State/province [9]
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Utrecht
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Norway
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Oslo
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Poland
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State/province [11]
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Wroclaw
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Portugal
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State/province [12]
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Lisboa
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Sweden
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Stockholm
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United Kingdom
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State/province [14]
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Manchester
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Funding & Sponsors
Primary sponsor type
Other
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Name
Charite University, Berlin, Germany
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Australian & New Zealand Children's Haematology/Oncology Group
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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St. Anna Kinderkrebsforschung, CCRI (co-sponsor, Austria)
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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European Organisation for Research and Treatment of Cancer - EORTC
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Address [3]
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Other collaborator category [4]
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Other
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Name [4]
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University Hospital Motol (Co-Sponsor Czech Republic)
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Address [4]
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Other collaborator category [5]
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Other
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Name [5]
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Copenhagen University Hospital, Rigshospitalet (co-sponsor, Denmark)
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Other collaborator category [6]
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Other
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Name [6]
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Turku University Central Hospital (co-sponsor, Finland)
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Address [6]
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Other collaborator category [7]
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Other
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Name [7]
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Centre Hospitalier Universitaire de Nice
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Address [7]
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Other collaborator category [8]
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Other
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Name [8]
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Our Lady's Chilrden's Hospital (Co-Sponsor Ireland)
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Other collaborator category [9]
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Other
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Tel Aviv Sourasky Medical Centre (Co-Sponsor Israel)
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Other collaborator category [10]
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Other
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Ospedale Pediatrico Bambino (co-sponsor, Italy)
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Other collaborator category [11]
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Other
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Name [11]
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Prinses Máxima Centrum (Co-Sponsor Netherlands)
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Other collaborator category [12]
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Other
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Oslo University Hospital (co-sponsor, Norway)
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Other collaborator category [13]
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Other
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Medical University of Wroclaw (Co-Sponsor Poland)
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Other collaborator category [14]
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Other
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Instituto Português de Oncologia de Lisboa (co-sponsor, Portugal)
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Address [14]
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Other collaborator category [15]
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Other
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Name [15]
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Karolinska University Hospital Stockholm (co-sponsor, Sweden)
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Address [15]
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Other collaborator category [16]
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Other
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Name [16]
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Spanish Society of Pediatric Hematology and Oncology (SEHOP) (Co-Sponsor Spain)
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Address [16]
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Other collaborator category [17]
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Other
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University Children's Hospital, Zurich
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Other collaborator category [18]
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Other
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Central Manchester University Hospitals NHS Foundation Trust (co-sponsor, UK)
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Ethics approval
Ethics application status
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Summary
Brief summary
The main goal of this study is to improve the outcome of children and adolescents with acute
lymphoblastic leukemia with high risk first relapse by optimization of treatment strategies
within a large international trial and the integration of new agents.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03590171
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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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Arend von Stackelberg, MD
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Address
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Charite University, Berlin, Germany
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Arend von Stackelberg, MD
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Address
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Phone
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+49(0)30-450666
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03590171
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