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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01117441
Registration number
NCT01117441
Ethics application status
Date submitted
3/05/2010
Date registered
5/05/2010
Date last updated
24/05/2022
Titles & IDs
Public title
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia
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Scientific title
International Collaborative Treatment Protocol For Children And Adolescents With Acute Lymphoblastic Leukemia
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Secondary ID [1]
0
0
AIEOP-BFM ALL 2009
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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:
Leukemia
0
0
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Condition category
Condition code
Cancer
0
0
0
0
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Leukaemia - Acute leukaemia
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
0
0
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Children's - Leukaemia & Lymphoma
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Cancer
0
0
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
0
0
0
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 - PEG-L-asparaginase
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - cytarabine
Treatment: Drugs - daunorubicin hydrochloride
Treatment: Drugs - dexamethasone
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - etoposide
Treatment: Drugs - ifosfamide
Treatment: Drugs - mercaptopurine
Treatment: Drugs - methotrexate
Treatment: Drugs - prednisone
Treatment: Drugs - thioguanine
Treatment: Drugs - vincristine sulfate
Treatment: Drugs - vindesine
Treatment: Drugs - daunoxome
Treatment: Drugs - fludarabine
Treatment: Other - Radiation Therapy
Active comparator: R1 control arm - see detailed protocol description
Experimental: R1 experimental arm - see detailed protocol description
Active comparator: R2 control arm - see detailed protocol description
Experimental: R2 experimental arm - see detailed protocol description
Active comparator: R-HR control arm - see detailed protocol description
Experimental: R-HR experimental arm - see detailed protocol description
Treatment: Drugs: PEG-L-asparaginase
see detailed protocol description
Treatment: Drugs: cyclophosphamide
see detailed protocol description
Treatment: Drugs: cytarabine
see detailed protocol description
Treatment: Drugs: daunorubicin hydrochloride
see detailed protocol description
Treatment: Drugs: dexamethasone
see detailed protocol description
Treatment: Drugs: doxorubicin hydrochloride
see detailed protocol description
Treatment: Drugs: etoposide
see detailed protocol description
Treatment: Drugs: ifosfamide
see detailed protocol description
Treatment: Drugs: mercaptopurine
see detailed protocol description
Treatment: Drugs: methotrexate
see detailed protocol description
Treatment: Drugs: prednisone
see detailed protocol description
Treatment: Drugs: thioguanine
see detailed protocol description
Treatment: Drugs: vincristine sulfate
see detailed protocol description
Treatment: Drugs: vindesine
see detailed protocol description
Treatment: Drugs: daunoxome
see detailed protocol description; only given by patients with poor MRD-response during the high risk treatment
Treatment: Drugs: fludarabine
see detailed protocol description; only given by patients with poor MRD-response during the high risk treatment
Treatment: Other: Radiation Therapy
for eligibility for radiotherapy see detailed protocol description
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Treatment: Other
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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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Event-free survival
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Assessment method [1]
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* Randomization R1: Event-free survival from time of randomization
* Historical comparison non-HR T-ALL: Event-free survival from diagnosis
* Historical comparison "MRD Non-Responders": Event-free survival from start of DNX-FLA (morphological non-response after HR-3' is no event for this study question)
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Timepoint [1]
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0
10 years from the start of recruitment
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Primary outcome [2]
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0
Disease-free survival
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Assessment method [2]
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* Randomization R2: Disease-free survival from time of randomization
* Historical comparison SR: Disease-free survival from start of Protocol M
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Timepoint [2]
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0
10 years from the start of recruitment
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Primary outcome [3]
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0
minimal residual disease (MRD)
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Assessment method [3]
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Randomization RHR: rate of MRD highly positive patients (MRD = 10-3) at TP2 (week 12)
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Timepoint [3]
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0
week 12 of treatment
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Secondary outcome [1]
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0
survival
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Assessment method [1]
0
0
All randomized and historical comparisons: Survival
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Timepoint [1]
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10 years from the start of recruitment
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Secondary outcome [2]
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treatment-related mortality
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Assessment method [2]
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All randomized and historical comparisons: treatment-related mortality in induction or CCR (overall and by chemotherapy/SCT)
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Timepoint [2]
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up to 25 months from the diagnosis
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Secondary outcome [3]
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0
adverse events
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Assessment method [3]
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0
All randomized and historical comparisons: incidence and frequency of adverse events of interest and serious adverse events
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Timepoint [3]
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0
up to 25 months from the diagnosis
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Secondary outcome [4]
0
0
event-free survival
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Assessment method [4]
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0
Randomization R-HR: Event-free survival from time of randomization
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Timepoint [4]
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0
10 years from the start of recruitment
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Secondary outcome [5]
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0
minimal residual disease
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Assessment method [5]
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"MRD Non-Responders": MRD levels after DNX-FLA
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Timepoint [5]
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after 24 weeks of treatment
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Eligibility
Key inclusion criteria
* newly diagnosed acute lymphoblastic leukemia
* age = 1 year (> 365 days) and < 18 years old (up to 17 years old and 365 days)
* no Ph+ (BCR/ABL or t(9;22)-positive) ALL
* no evidence of pregnancy or lactation period
* no participation in another clinical study
* patient enrolled in a participating center
* written informed consent
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Minimum age
1
Year
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Maximum age
18
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
* pre-treatment with cytostatic drugs
* pre-treatment with cytostatic drugs
* steroid pre-treatment with = 1 mg/kg/d for more than two weeks during the last month before diagnosis
* treatment started according to another protocol
* underlying diseases that prohibit treatment according to the protocol
* ALL diagnosed as second malignancy steroid pre-treatment with = 1 mg/kg/d for more than two weeks during the last month before diagnosis
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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
Factorial
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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
1/06/2010
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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
31/12/2021
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Sample size
Target
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Accrual to date
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Final
6136
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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The Sydney Children's Hospital, Centre for Children's Cancer and Blood Disorders - Randwick
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Recruitment hospital [2]
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The Children's Hospital at Westmead, Department of Oncology - Westmead
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Recruitment postcode(s) [1]
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NSW 2031 - Randwick
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Recruitment postcode(s) [2]
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NSW 2145 - Westmead
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Recruitment outside Australia
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Austria
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State/province [1]
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Dornbirn
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Austria
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Graz
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Austria
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Innsbruck
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Austria
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Klagenfurt
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Austria
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Leoben
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Austria
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Linz
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Austria
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Salzburg
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Austria
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Wien
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Czechia
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Brno
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Czechia
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Hradec Králové
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Olomouc
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Czechia
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Ostrava-Poruba
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Czechia
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Plzen
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Czechia
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Praha 5
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Czechia
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Ústí nad Labem
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Czechia
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Ceské Budejovice
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Aachen
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Augsburg
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Bayreuth
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Chemnitz
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Zürich
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Funding & Sponsors
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University Hospital Schleswig-Holstein
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Other
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Deutsche Krebshilfe e.V., Bonn (Germany)
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Summary
Brief summary
Rationale/Purpose: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. It is not yet known which combination chemotherapy regimen is more effective in treating young patients with acute lymphoblastic leukemia (ALL). This trial is studying several different combination chemotherapy regimens to compare how well they work in treating young patients with ALL. Study objectives Primary study questions: * Non high-risk (non-HR) precursor-B ALL (pB-ALL) patients with TEL/AML1-negative ALL or unknown TEL/AML1 status and flow cytometry minimal residual disease (MRD) in bone marrow on day 15 \<0.1% or with TEL/AML1-positive ALL (randomized study question R1): Can the daunorubicin dose in Protocol IA be safely reduced by 50 % with a non-inferior EFS and a reduction of toxicity (treatment-related mortality and AE/SAE in Protocol I)? * Patients with pB-ALL and risk group medium risk (MR) (randomized study question R2): Can the clinical outcome be improved by protracted asparagine depletion achieved through application of intensified PEG-L-asparaginase during reintensification and early maintenance? * High-risk (HR) patients (as identified by day 33 - randomized study question RHR): Can the clinical outcome be improved by protracted exposure to PEG-L-asparaginase during Protocol IB? Secondary study questions: * Standard risk (SR) patients identified by at least one sensitive marker: Is the clinical outcome comparable to that obtained in SR patients (identified with two sensitive markers) in AIEOP-BFM ALL 2000, or can the outcome even be improved with the use of PEG-L-asparaginase instead of native E. coli L-ASP? * T-ALL non-HR patients: Can the high level of outcome which was obtained for these patients in study AIEOP-BFM ALL 2000 be preserved or even improved with the use of PEG-L-ASP instead of native E. coli L-ASP? * HR patients with persisting high MRD levels despite the use of the HR blocks in the intensified consolidation phase "MRD Non-Responders": Is it possible to improve the outcome and to achieve a further reduction of leukemic cell burden by administration of an innovative treatment schedule (DNX-FLA)? * Patients participating in the randomized asparaginase studies (pB-ALL/MR, HR): Are asparaginase activity and asparaginase antibodies associated with development of allergic reactions, and do they have an effect on the outcome of the patients? * What is the relative value of different methods of MRD monitoring in the definition of alternative stratification systems within a BFM-oriented protocol?
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Trial website
https://clinicaltrials.gov/study/NCT01117441
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Trial related presentations / publications
Conter V, Bartram CR, Valsecchi MG, Schrauder A, Panzer-Grumayer R, Moricke A, Arico M, Zimmermann M, Mann G, De Rossi G, Stanulla M, Locatelli F, Basso G, Niggli F, Barisone E, Henze G, Ludwig WD, Haas OA, Cazzaniga G, Koehler R, Silvestri D, Bradtke J, Parasole R, Beier R, van Dongen JJ, Biondi A, Schrappe M. Molecular response to treatment redefines all prognostic factors in children and adolescents with B-cell precursor acute lymphoblastic leukemia: results in 3184 patients of the AIEOP-BFM ALL 2000 study. Blood. 2010 Apr 22;115(16):3206-14. doi: 10.1182/blood-2009-10-248146. Epub 2010 Feb 12. Flohr T, Schrauder A, Cazzaniga G, Panzer-Grumayer R, van der Velden V, Fischer S, Stanulla M, Basso G, Niggli FK, Schafer BW, Sutton R, Koehler R, Zimmermann M, Valsecchi MG, Gadner H, Masera G, Schrappe M, van Dongen JJ, Biondi A, Bartram CR; International BFM Study Group (I-BFM-SG). Minimal residual disease-directed risk stratification using real-time quantitative PCR analysis of immunoglobulin and T-cell receptor gene rearrangements in the international multicenter trial AIEOP-BFM ALL 2000 for childhood acute lymphoblastic leukemia. Leukemia. 2008 Apr;22(4):771-82. doi: 10.1038/leu.2008.5. Epub 2008 Jan 31. Moricke A, Zimmermann M, Reiter A, Henze G, Schrauder A, Gadner H, Ludwig WD, Ritter J, Harbott J, Mann G, Klingebiel T, Zintl F, Niemeyer C, Kremens B, Niggli F, Niethammer D, Welte K, Stanulla M, Odenwald E, Riehm H, Schrappe M. Long-term results of five consecutive trials in childhood acute lymphoblastic leukemia performed by the ALL-BFM study group from 1981 to 2000. Leukemia. 2010 Feb;24(2):265-84. doi: 10.1038/leu.2009.257. Epub 2009 Dec 10. Wurthwein G, Lanvers-Kaminsky C, Siebel C, Gerss J, Moricke A, Zimmermann M, Stary J, Smisek P, Schrappe M, Rizzari C, Zucchetti M, Hempel G, Wicha SG, Boos J; AIEOP-BFM ALL 2009 Asparaginase Working Party. Population Pharmacokinetics of PEGylated Asparaginase in Children with Acute Lymphoblastic Leukemia: Treatment Phase Dependency and Predictivity in Case of Missing Data. Eur J Drug Metab Pharmacokinet. 2021 Mar;46(2):289-300. doi: 10.1007/s13318-021-00670-8. Epub 2021 Feb 17. Tasian SK, Peters C. Targeted therapy or transplantation for paediatric ABL-class Ph-like acute lymphocytic leukaemia? Lancet Haematol. 2020 Dec;7(12):e858-e859. doi: 10.1016/S2352-3026(20)30369-0. No abstract available. Cario G, Leoni V, Conter V, Attarbaschi A, Zaliova M, Sramkova L, Cazzaniga G, Fazio G, Sutton R, Elitzur S, Izraeli S, Lauten M, Locatelli F, Basso G, Buldini B, Bergmann AK, Lentes J, Steinemann D, Gohring G, Schlegelberger B, Haas OA, Schewe D, Buchmann S, Moericke A, White D, Revesz T, Stanulla M, Mann G, Bodmer N, Arad-Cohen N, Zuna J, Valsecchi MG, Zimmermann M, Schrappe M, Biondi A. Relapses and treatment-related events contributed equally to poor prognosis in children with ABL-class fusion positive B-cell acute lymphoblastic leukemia treated according to AIEOP-BFM protocols. Haematologica. 2020 Jul;105(7):1887-1894. doi: 10.3324/haematol.2019.231720. Epub 2019 Oct 10. Kroll M, Kaupat-Bleckmann K, Morickel A, Altenl J, Schewel DM, Stanullal M, Zimmermann M, Schrappe M, Cario G. Methotrexate-associated toxicity in children with Down syndrome and acute lymphoblastic leukemia during consolidation therapy with high dose methotrexate according to ALL-BFM treatment regimen. Haematologica. 2020 Apr;105(4):1013-1020. doi: 10.3324/haematol.2019.224774. Epub 2019 Aug 1. Wurthwein G, Lanvers-Kaminsky C, Hempel G, Gastine S, Moricke A, Schrappe M, Karlsson MO, Boos J. Population Pharmacokinetics to Model the Time-Varying Clearance of the PEGylated Asparaginase Oncaspar(R) in Children with Acute Lymphoblastic Leukemia. Eur J Drug Metab Pharmacokinet. 2017 Dec;42(6):955-963. doi: 10.1007/s13318-017-0410-5.
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Public notes
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Contacts
Principal investigator
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Martin Schrappe, MD PhD
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Department of Pediatrics, University Hospital of Schleswig-Holstein, Campus Kiel
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https://clinicaltrials.gov/study/NCT01117441
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