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AIEOP BFM ALL 2017 II, Version 1 5 01 07 2018, AIEOP BFM ALL 2017. INTERNATIONAL COLLABORATIVE TREATMENT PROTOCOL FOR CHILDREN. AND ADOLESCENTS WITH ACUTE LYMPHOBLASTIC LEUKEMIA, Collaborative groups National Coordinators. AIEOP Italy Andrea Biondi, Vice Coordinator AIEOP Valentino Conter. Clinica Pediatrica dell Universit di Milano Bicocca. Fondazione MBBM, Via Pergolesi 33, 20900 Monza MI Italy. Tel 39 039 233 6816, E Mail abiondi unimib gmail com.
BFM A Austria Georg Mann, Vice Coordinator BFM A Andishe Attarbaschi. St Anna Kinderspital, Kinderspitalgasse 6, 1090 Wien Austria. Tel 43 1 40470 250, E Mail georg mann stanna at, BFM G Germany Martin Schrappe. Vice Coordinator BFM G Gunnar Cario, Universit tsklinikum Schleswig Holstein Campus Kiel. Klinik f r Kinder und Jugendmedizin I, Arnold Heller Str 3 Haus 9.
24105 Kiel Germany, Tel 49 431 500 20102, E Mail m schrappe pediatrics uni kiel de. BFM CH Switzerland Felix Niggli, Vice Coordinator BFM CH Jean Pierre Bourquin. Universit ts Kinderklinik, Steinwiesstr 75, 8032 Z rich Switzerland. Tel 41 44 266 7823, E Mail felix niggli kispi uzh ch. ANZCHOG Australia Draga Barbaric, Centre for Children s Cancer and Blood Disorders.
Sydney Children s Hospital, High Street Randwick NSW 2031 Australia. Tel 61 2 9382 1721, E Mail draga barbaric sesiahs health nsw gov au. AIEOP BFM ALL 2017 III, Version 1 5 01 07 2018, CPH Czech Republic Jan Stary. Department of Pediatric Hematology and Oncology, University Hospital Motol. V Uvalu 84, 150 06 Praha 5 Czech Republic, Tel 420 2 24436401.
E Mail jan stary lfmotol cuni cz, INS Israel Sarah Elitzur. Schneider Children s Medical Center of Israel, Pediatric Hematology Oncology. Petah Tikva 49202 Israel, Tel 972 3 925 3697, E Mail Sarhae clalit org il. SPHOS Slovakia Alexandra Kolenova, Comenius University Children s Hospital. Department of Pediatric Hematology and Oncology, 83340 Bratislava Slovakia.
Tel 421 2 59371 376, E Mail sasa kolenova gmail com. AIEOP BFM ALL 2017, Version 1 5 01 07 2018, AIEOP BFM ALL 2017 all precB ALL. pB ALL Prot IA Pred, Overview of treatment Clinical biological factors MRD TP1. early non HR early HR, Random eHR, Consol B short Consol B extBZM Consol B ext. SR MR HR Experimental, Prot M Prot M Random HR Experimental therapy.
different treatments, MRD TP HR1, HR 2 1 Blina cycle i th MTX. Prot II Prot II, Blina Poor, MRD TP HR Blina1 d29, Blina Good HR 2. HR 3 2 Blina cycle i th MTX HR 3, MT MT Blina cycle. MRD TP HR3 MRD TP HR Blina2 d29 MRD TP HR3, 5x10 4 5x10 4 neg. DNX FLA 3x Prot III alloHSCT, MRD TP D F MT, For patients with true PCR MRD negativity at.
TP1 MRD analysis at TP2 is not required MRD MRD, 5x10 4 5x10 4 neg. For definition of Blina Response see protocol Only MRD time points are depicted. considered as event molecular non response, AlloHSCT indication of HR patients depends on. Exp ther alloHSCT in this overview that are crucial. genetics and MRD at TP2 alloHSCT, for treatment stratification. AIEOP BFM ALL 2017, Version 1 5 01 07 2018, AIEOP BFM ALL 2017. PGR PPR T ALL, Prot IA Dexa Prot IA Pred CPM, Overview of treatment.
Early Response MRD TP1, early SR early non SR, Prot IB 2 reg Prot IB 2 reg Prot IB 2 long. Prot M HR 1, Prot II HR 3, MRD TP HR3, MT MRD MRD, 5x10 4 5x10 4 neg. DNX FLA 3x Prot III alloHSCT, MRD TP D F, For patients with true PCR MRD negativity. at TP1 MRD analysis at TP2 is not required MRD MRD. considered as event molecular non 5x10 4 5x10 4 neg. response Only MRD time points are depicted, AlloHSCT indication of HR patients Exp ther alloHSCT in this overview that are crucial. depends on genetics and MRD at TP2, for treatment stratification.
AIEOP BFM ALL 2017 Synopsis 6, Version 1 5 01 07 2018. AIEOP BFM ALL 2017 Study Synopsis, Title International collaborative treatment protocol for children and adolescents with acute. lymphoblastic leukemia, Short title AIEOP BFM ALL 2017. National Martin Schrappe Germany Coordinating Principle Investigator. coordinators Andrea Biondi Italy, Georg Mann Austria. Felix Niggli Switzerland, Draga Barbaric Australia.
Jan Stary Czech Republic, Sarah Elitzur Israel, Alexandra Kolenova Slovakia. Sponsor Universit tsklinikum Schleswig Holstein Kiel Germany. Study Study start July 15 2018, timetable 5 years recruitment until July 14 2023. 5 years minimum follow up from start of treatment for each patient until July 14 2028. Patients Children and adolescents 18 years of age with acute lymphoblastic leukemia. Risk pB ALL or unknown immunophenotype, Stratification. early High Risk early HR, no complete remission on day 33 or. positivity for KMT2A AFF1 or, positivity for TCF3 HLF 1 or.
hypodiploidy 45 chromosomes or, FCM MRD in BM on day 15 10 and not ETV6 RUNX1 positive or. IKZF1plus and PCR MRD at TP1 positive or inconclusive and not positive for. ETV6 RUNX1 TCF3 PBX1 or KMT2A rearr other than KMT2A AFF1 or. PCR MRD at TP1 5x10 4 or, age 1 year and any KMT2A rearrangement. High Risk HR, no complete remission on day 33 or, positivity for KMT2A AFF1 or. positivity for TCF3 HLF or, hypodiploidy 45 chromosomes or. FCM MRD in BM on day 15 10 and not ETV6 RUNX1 positive or. IKZF1plus and PCR MRD at TP1 positive or inconclusive and not positive for. ETV6 RUNX1 TCF3 PBX1 or KMT2A rearr other than KMT2A AFF1 or. PCR MRD at TP1 5x10 4 and positive 5x10 4 at TP2 PCR MRD SER or. PCR MRD at TP2 5x10 4 or, age 1 year and any KMT2A rearrangement.
Standard Risk SR, no HR criteria and, PCR MRD at TP1 negative for all investigated markers with at least one marker. with a quantitative range of 10 4 or, inconclusive PCR MRD result at TP1 and PCR MRD not positive at TP2 and. FCM MRD in BM d15 0 1, Medium Risk MR, no HR criteria and no SR criteria. Patients with TCF3 HLF also qualify for experimental treatments e g with BCL2 inhibitors if those. drugs are available not part of this study, AIEOP BFM ALL 2017 Synopsis 7. Version 1 5 01 07 2018, early Standard Risk early SR.
complete remission on day 33 and, FCM MRD in BM on day 15 10 and. Prednisone Good Response and, PCR MRD at TP1 negative for all investigated markers with at least one marker. with a quantitative range of 10 4 or, inconclusive PCR MRD result at TP1 and FCM MRD in BM d15 0 1. High Risk HR, No complete remission on day 33 or, FCM MRD in BM on day 15 10 or. Prednisone Poor Response or, PCR MRD at TP2 5x10 4.
non High Risk non HR, No HR criteria, Experimental groups eligible for possible other treatments not part of this study. Positivity for TCF3 HLF, MRD non response 5x10 4 after DNX FLA. Primary Randomization R eHR Early High risk early HR pB ALL defined by genetics and or. study inadequate treatment response over the course of induction Can the pEFS from time. questions of randomization be improved by additional therapy with the proteasome inhibitor. Bortezomib during an extended consolidation treatment phase compared with. standard extended consolidation, Randomization R HR High risk HR pB ALL defined by genetics and or inadequate. treatment response by the end of consolidation Can the pEFS from time of. randomization be improved by a treatment concept including two cycles of post. consolidation immunotherapy with Blinatumomab 15 g m d for 28 days per cycle. plus 4 doses intrathecal Methotrexate replacing two conventional highly intensive. chemotherapy courses, Randomization R MR Intermediate risk MR pB ALL defined by genetics and. intermediate MRD response Can the probability of disease free survival pDFS from. time of randomization be improved by additional therapy with one cycle of post. reintensification immunotherapy with Blinatomomab 15 g m d for 28 days. Randomization R T Early non standard risk early non SR T ALL patients defined by. treatment response over the course of induction Can the pEFS from time of. randomization be improved by the extension of the standard of care consolidation. phase by 14 days with an increase of the consolidation cumulative doses of. Cyclophosphamide Cytarabine and 6 Mercaptopurine by 50. AIEOP BFM ALL 2017 Synopsis 8, Version 1 5 01 07 2018.
Secondary All randomizations Can the overall survival be improved by the treatment in the. study experimental arm, All randomizations What is the incidence of treatment related toxicities and mortality in. the experimental arm compared to the standard arm, Randomization R eHR Can the MRD load after consolidation treatment be reduced by. the additional treatment with Bortezomib, Randomization R HR Can treatment related life threatening complications and mortality. during the intensified consolidation phase of high risk treatment be reduced when. replacing two intensive chemotherapy courses by two cycles of immunotherapy with. Blinatumomab, Randomization R HR What is the proportion of patients with insufficient MRD response. to Blinatumomab as defined in the protocol as compared to the MRD response after. the HR 2 block in the control arm, Randomization R HR Can the MRD load after the first treatment cycle.
HR 2 Blinatumomab and the second cycle HR 3 Blinatumomab be reduced in the. experimental arm when compared with conventional intensive chemotherapy. Randomization R MR What is the proportion of patients with positive MRD after. reintensification Protocol II who become MRD negative over the Blinatumomab cycle. compared to 4 weeks of standard maintenance therapy. Randomization R T Can the MRD load after consolidation treatment be reduced by. extension of the consolidation phase, Standard risk patients Is the clinical outcome comparable to that obtained for standard. risk patients in study AIEOP BFM ALL 2009, Primary For the randomized study questions the primary endpoint will be the time from. endpoints randomization until the first event defined as follows. Randomization R eHR R HR and R T Cytomorphological or molecular non response. resistance to protocol treatment considered as event at day zero relapse second. malignancy or death from any cause This will be called EFS time. Randomization R MR Relapse second malignancy or death from any cause This will. be called DFS time, Secondary Survival starting at the same time point as the EFS DFS. Frequency and incidence of treatment related mortality in induction or CCR. Frequency and incidence of AE of interest and SAE in specific protocol phases. randomized arms and overall during follow up, MRD load after the randomized treatment phases R eHR R HR R MR and R T. MRD load after the first second cycle of Blinatumomab or after the HR 2 HR 3 block. Proportion of patients with poor MRD response to the first Blinatumomab cycle. Blinatumomab Poor Response R HR, Study design International inter group multi center open label randomized clinical trial Phase III.
Treatment AIEOP Italy, groups BFM A Austria, BFM G Germany. BFM CH Switzerland, ANZCHOG Australia, CPH Czech Republic. INS Israel, SPHOS Slovakia, AIEOP BFM ALL 2017 Synopsis 9. Version 1 5 01 07 2018, Inclusion newly diagnosed acute lymphoblastic leukemia or. criteria newly diagnosed mixed phenotype acute leukemia MPAL meeting one of the following. biphenotypic with a dominant T or B lineage assignment. bilineal either with a dominant lymphoblastic population or if another reasonable. rationale exists to treat the patient with an ALL based therapy regimen. newly diagnosed acute undifferentiated leukemia, age 18 years up to 17 years and 365 days at the day of diagnosis.
patient enrolled in a participating center, written informed consent to trial participation and transfer and processing of data. Exclusion Ph BCR ABL1 or t 9 22 positive ALL 2, criteria bilineal leukemia with a lymphoblastic and a separate non lymphoblastic 10 of total. cells blast subset, pre treatment with cytostatic drugs. glucocorticoid 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 disease that does not allow treatment according to the protocol. ALL diagnosed as second malignancy and preceding chemotherapy and or radiotherapy. evidence of pregnancy or lactation period, Sexually active adolescents not willing to use highly effective contraceptive method.
pearl index 1 until 12 months after end of anti leukemic therapy. participation in another clinical trial except for add on trials within the scope of. supportive care approved by the sponsor, live vaccine immunization within 2 weeks before start of protocol treatment. Study size The participating groups are expected to recruit at least 1000 patients per year 850 with. calculation pB ALL and 150 with T ALL resulting in the recruitment of 5000 patients during the. recruitment period of 5 years, Randomization R eHR Patients who fulfill the criteria of early HR pB ALL have an. estimated 4 year pEFS of 68 Taking into account 2 interim analyses at 2 and 3 years. from randomization 775 randomized patients 213 events would be appropriate to. detect a difference of 9 HR 0 68 with 0 05 two sided and power 0 8 under the. assumption of proportional hazards Early HR pB ALL account for about 20 of the. patients and the randomization rate is expected to be 80 The number of patie. AIEOP BFM ALL 2017 Version 1 5 01 07 2018 all T ALL AIEOP BFM ALL 2017 T ALL Overviewof treatment Early Response MRD TP1 Prot IA Dexa Prot IA Pred CPM early non SR

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