Back to resultsResearch Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years (AML2012)
Primary Purpose
Pediatric Acute Myeloblastic Leukemia
Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Randomisation course 1 mitoxantrone versus DaunoXome
Randomisation course 2 ADxE versus FLADx
Sponsored by
About this trial
This is an interventional treatment trial for Pediatric Acute Myeloblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- AML as defined by the WHO diagnostic criteria
- Age < 19 years at time of diagnosis
- Written informed consent
Exclusion Criteria:
- Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
- AML secondary to previous bone marrow failure syndrome.
- Down syndrome (DS)
- Acute promyelocytic leukaemia (APL)
- Myelodysplastic syndrome (MDS)
- Juvenile Myelomonocytic Leukaemia (JMML)
- Known intolerance to any of the chemotherapeutic drugs in the protocol.
- Fanconi anaemia
- Major organ failure precluding administration of planned chemotherapy.
- Positive pregnancy test
- Lactating female or female of childbearing potential not using adequate contraception
Sites / Locations
- HUDERF, L'Hôpital des Enfants Hématologie / OncologieRecruiting
- UZ Brussel, Pediatrische Hemato-Oncologie F930Recruiting
- UCL, Cliniques Universitaires Saint-LucRecruiting
- Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-OncologyRecruiting
- UZ Leuven, Kinder Hemato-OncologieRecruiting
- CHR CitadelleRecruiting
- CHC EspéranceRecruiting
- Department of Pediatrics, Aarhus University Hospital SkejbyRecruiting
- Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of CopenhagenRecruiting
- Tallinn Children's Hospital, Dep. Hematology oncology
- Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central HospitalRecruiting
- Department of Pediatrics, Kuopio University HospitalRecruiting
- Department of Pediatrics, Oulu University HospitalRecruiting
- Department of Pediatrics, Tampere University Central HospitalRecruiting
- Department of Pediatrics, Turku University Central HospitalRecruiting
- Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong KongRecruiting
- Children´s Hospital, Landspitali University Hospital
- VU University Medical Center Department of Pediatric Oncology/HematologyRecruiting
- Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric OncologyRecruiting
- Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center GroningenRecruiting
- University Medical Center Nijmegen Department of Pediatric Oncology/HematologRecruiting
- Erasmus MC - Sophia Childrens Hospital University Medical Center RotterdamRecruiting
- Department of Pediatrics, Haukeland University Hospital, BergenRecruiting
- Pediatric Dept, Women and Children's Division, Oslo University Hospital RikshospitaletRecruiting
- Department of Pediatrics, University Hospital of North Norway, TromsoeRecruiting
- Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University HospitalRecruiting
- Queen Silvias Childrens and Adolescents HospitalRecruiting
- Dept of Pediatrics, Linköpings University HospitalRecruiting
- Dept of Pediatrics, Skåne University HospitalRecruiting
- Astrid Lindgrens Barnsjukhus, Karolinska University HospitalRecruiting
- Dept of Pediatrics, Norrlands University HospitalRecruiting
- Dept of Pediatrics, Akademiska barnsjukhusetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Arm Label
Standard arm MEC and ADxE
Experimental DxEC and standard ADxE
Standard arm MEC and experimental FLADx
Experimental DxEC and experimental FLADx
Arm Description
Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two
Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two
Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two
Outcomes
Primary Outcome Measures
Minimal residual disease
MRD will be measured by flow cytometry. In the randomisation for course 1 the endpoint is at day 22. In the randomisation for course 2 the endpoint is immediately before start of consolidation
Secondary Outcome Measures
Event-free survival
Event-free survival at five years
Acute toxicity
Hematological and other organ toxicity after each course
Long-term toxicity
Long-term toxicity in particular cardiac toxicity
Overall survival
Overall survival at five years
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01828489
Brief Title
Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
Acronym
AML2012
Official Title
NOPHO-DBH AML 2012 Protocol. Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2018 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vastra Gotaland Region
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study evaluates the effect of different induction courses in children and adolescents with newly diagnosed acute myeloid leukemia. In the first course patients are randomised to receive either standard anthracycline therapy with mitoxantrone or experimental DaunoXome. In the second course patients are randomised between standard treatment with ADxE (cytarabine, DaunoXome, etoposide) or experimental therapy with FLADx (fludarabine, cytarabine, DaunoXome).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Acute Myeloblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard arm MEC and ADxE
Arm Type
Active Comparator
Arm Description
Standard protocol arm with mitoxantrone in first course (MEC) and standard ADxE treatment in course two
Arm Title
Experimental DxEC and standard ADxE
Arm Type
Experimental
Arm Description
Experimental arm with DaunoXome in course one (DxEC) and standard ADxE treatment in course two
Arm Title
Standard arm MEC and experimental FLADx
Arm Type
Experimental
Arm Description
Experimental arm with standard MEC in the first course (MEC) and experimental treatment with FLADx in course two
Arm Title
Experimental DxEC and experimental FLADx
Arm Type
Experimental
Arm Description
Experimental treatment with DaunoXome in course one (DxEC) and experimental treatment with FLADx in course two
Intervention Type
Drug
Intervention Name(s)
Randomisation course 1 mitoxantrone versus DaunoXome
Intervention Description
In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
Intervention Type
Drug
Intervention Name(s)
Randomisation course 2 ADxE versus FLADx
Intervention Description
The second course is randomised to either ADxE (standard arm) or FLADx
Primary Outcome Measure Information:
Title
Minimal residual disease
Description
MRD will be measured by flow cytometry. In the randomisation for course 1 the endpoint is at day 22. In the randomisation for course 2 the endpoint is immediately before start of consolidation
Time Frame
On day 22 after the first induction and after second induction
Secondary Outcome Measure Information:
Title
Event-free survival
Description
Event-free survival at five years
Time Frame
5 years
Title
Acute toxicity
Description
Hematological and other organ toxicity after each course
Time Frame
six months
Title
Long-term toxicity
Description
Long-term toxicity in particular cardiac toxicity
Time Frame
10 years
Title
Overall survival
Description
Overall survival at five years
Time Frame
Five years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
AML as defined by the WHO diagnostic criteria
Age < 19 years at time of diagnosis
Written informed consent
Exclusion Criteria:
Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy
AML secondary to previous bone marrow failure syndrome.
Down syndrome (DS)
Acute promyelocytic leukaemia (APL)
Myelodysplastic syndrome (MDS)
Juvenile Myelomonocytic Leukaemia (JMML)
Known intolerance to any of the chemotherapeutic drugs in the protocol.
Fanconi anaemia
Major organ failure precluding administration of planned chemotherapy.
Positive pregnancy test
Lactating female or female of childbearing potential not using adequate contraception
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonas Abrahamsson, MD, PhD
Phone
+46 707695159
Email
jonas.abrahamsson@vgregion.se
First Name & Middle Initial & Last Name or Official Title & Degree
Anna Schröder-Håkansson
Email
anna.schroder-hakansson@vgregion.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonas Abrahamsson, MD, PhD
Organizational Affiliation
Children's Cancer Centre, Queen Silvias Childrens and Adolescents Hospital 416 85 Gothenburg, Sweden
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Barbara de Moerloose, MD, PhD
Organizational Affiliation
Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology, 3K12D, De Pintelaan 185 - 9000 Gent, Belgium
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ha Shau-Yin, MD, PhD
Organizational Affiliation
Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong, Pokfulam, Hong Kong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Henrik Hasle, MD, PhD
Organizational Affiliation
Department of Pediatrics, Aarhus University Hospital Skejby 8200 Aarhus N, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kirsi Jahnukainen, MD, PhD
Organizational Affiliation
Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital, PL 281, 00029 Helsinki, Finland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olafur G Jonsson, MD, PhD
Organizational Affiliation
Children´s Hospital, Landspitali University Hospital, Hringbraut, 101 Reykjavik, Iceland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gertjan Kaspers, MD, PhD
Organizational Affiliation
Department of Pediatrics, VU University Medical Center Amsterdam De Boelelaan 1117, NL-1081 HV Amsterdam, The Netherlands
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Birgitte Lausen, MD, PhD
Organizational Affiliation
Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen, Denmark
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Josefine Palle, MD, PhD
Organizational Affiliation
Dept of Woman´s and Children´s Health, Uppsala University, Uppsala, Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kadri Saks, MD, PhD
Organizational Affiliation
Tallinn Children's Hospital, Dep. Hematology oncology, Tervise 28, Tallinn 13419, Estonia.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bernward Zeller, MD, PhD
Organizational Affiliation
Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet, Mailbox 4950 Nydalen, N-0424 Oslo, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
HUDERF, L'Hôpital des Enfants Hématologie / Oncologie
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Dedeken, MD, PhD
Phone
+32 2 4773311
Email
laurence.dedeken@huderf.be
Facility Name
UZ Brussel, Pediatrische Hemato-Oncologie F930
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jutte Van der Werff ten Bosch, MD, PhD
Phone
+32 2 4774111
Email
JVDWerff@uzbrussel.be
Facility Name
UCL, Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie Dupont, MD, PhD
Phone
+32 2 7641111
Email
sophie.dupont@uclouvain.be
Facility Name
Ghent University Hospital, Children´s Hospital, Princess Elisabeth, Department of Pediatric Hematology-Oncology
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara de Moerloose, MD, PhD
Email
barbara.demoerloose@uzgent.be
Facility Name
UZ Leuven, Kinder Hemato-Oncologie
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Uyttebroeck, MD, PhD
Phone
+32 16 33 22 11
Email
anne.uyttebroeck@uzleuven.be
Facility Name
CHR Citadelle
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Françoise Dresse, MD, PhD
Phone
+32 42238980
Email
marie.francoise.dresse@chrcitadelle.be
Facility Name
CHC Espérance
City
Montegnée
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pierre Philippet, MD, PhD
Phone
+32 42249111
Email
pierre.philippet@chc.be
Facility Name
Department of Pediatrics, Aarhus University Hospital Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Henrik Hasle, MD, PhD
Email
hasle@dadlnet.dk
Facility Name
Dept of Pediatrics and Adolescent Medicine, Rigshospitalet, University of Copenhagen
City
Copenhagen
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Birgitte Lausen, MD, PhD
Email
birgitte.lausen@rh.regionh.dk
Facility Name
Tallinn Children's Hospital, Dep. Hematology oncology
City
Tallinn
ZIP/Postal Code
13419
Country
Estonia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kadri Saks, MD, PhD
Email
kadri.saks@lastehaigla.ee
Facility Name
Division of Hematology-Oncology and Stem Cell Transplantation, Children's Hospital, Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
00029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsi Jahnukainen, MD, PhD
Email
kirsi.jahnukainen@ki.se
Facility Name
Department of Pediatrics, Kuopio University Hospital
City
Kuopio
ZIP/Postal Code
70211
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pekka Riikonen
Phone
+358 447172392
Email
pekka.riikonen@kuh.fi
First Name & Middle Initial & Last Name & Degree
Pekka Riikonen
Facility Name
Department of Pediatrics, Oulu University Hospital
City
Oulu
ZIP/Postal Code
90029
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Merja Möttönen
Phone
+358 83155251
Email
merja.mottonen@ppshp.fi
First Name & Middle Initial & Last Name & Degree
Merja Möttönen
Facility Name
Department of Pediatrics, Tampere University Central Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikko Arola
Phone
+358 3 31164386
Email
mikko.arola@pshp.fi
First Name & Middle Initial & Last Name & Degree
Mikko Arola
Facility Name
Department of Pediatrics, Turku University Central Hospital
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Minna Koskenvuo, MD, PhD
Phone
+358 50 3624430
Email
minna.koskenvuo@utu.fi
First Name & Middle Initial & Last Name & Degree
Minna Koskenvuo
Facility Name
Dept of Paediatrics & Adolescent Medicine, Queen Mary Hospital, The University of Hong Kong
City
Hong Kong
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shau-Yin Ha, MD, PhD
Email
syha@hku.hk
Facility Name
Children´s Hospital, Landspitali University Hospital
City
Reykjavik
Country
Iceland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olafur Jonsson, MD, PhD
Email
olafurgi@landspitali.is
Facility Name
VU University Medical Center Department of Pediatric Oncology/Hematology
City
Amsterdam
ZIP/Postal Code
1007
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gertjan Kaspers, MD, PhD
Email
GJL.Kaspers@vumc.nl
Facility Name
Emma Children's Hospital/ Amsterdam Medical Center Department of Pediatric Oncology
City
Amsterdam
ZIP/Postal Code
1100 DD
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huib Caron, MD, PhD
Email
h.n.caron@amc.uva.nl
Facility Name
Department of Pediatric Oncology/Hematology Beatrix childrens hospital / University Medical Center Groningen
City
Groningen
ZIP/Postal Code
9700 RB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eveline de Bont, MD, PhD
Email
e.de.bont@bkk.umcg.nl
Facility Name
University Medical Center Nijmegen Department of Pediatric Oncology/Hematolog
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dunja te Loo, MD, PhD
Email
m.teloo@cukz.umcn.nl
Facility Name
Erasmus MC - Sophia Childrens Hospital University Medical Center Rotterdam
City
Rotterdam
ZIP/Postal Code
3000 CB
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marry van den Heuvel-Eibrink, MD, PhD
Email
m.vandenheuvel@erasmusmc.nl
Facility Name
Department of Pediatrics, Haukeland University Hospital, Bergen
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorota, Wojcik
Phone
+47 55 97 50 00
Email
dorota.malgorzata.wojcik@helse-bergen.no
First Name & Middle Initial & Last Name & Degree
Dorota Wojcik
Facility Name
Pediatric Dept, Women and Children's Division, Oslo University Hospital Rikshospitalet
City
Oslo
ZIP/Postal Code
N-0424
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bernward Zeller, MD, PhD
Email
bernward.zeller@ous-hf.no
Facility Name
Department of Pediatrics, University Hospital of North Norway, Tromsoe
City
Tromsoe
ZIP/Postal Code
N-9038
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Trond Flaegstad
Phone
+47 91507766
Email
Trond.Flaegstad@unn.no
First Name & Middle Initial & Last Name & Degree
Trond Flaegstad
Facility Name
Department of Cancer and Haemathology, St Olavs Hospital, Trondheim University Hospital
City
Trondheim
ZIP/Postal Code
N-7006
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Svein Kolmannskog
Phone
+47 815 55 850
Email
svein.kolmannskog@ntnu.no
First Name & Middle Initial & Last Name & Degree
Svein Kolmannskog
Facility Name
Queen Silvias Childrens and Adolescents Hospital
City
Gothenburg
ZIP/Postal Code
41685
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonas Abrahamsson, MD, PhD
Email
jonas.abrahamsson@vgregion.se
First Name & Middle Initial & Last Name & Degree
Jonas Abrahamsson
Facility Name
Dept of Pediatrics, Linköpings University Hospital
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mikael Behrendtz, MD, PhD
First Name & Middle Initial & Last Name & Degree
Mikael Behrendtz
Facility Name
Dept of Pediatrics, Skåne University Hospital
City
Lund
ZIP/Postal Code
22241
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornelis Pronk, MD, PhD
Email
kees-jan.pronk@med.lu.se
Facility Name
Astrid Lindgrens Barnsjukhus, Karolinska University Hospital
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karin Belander-Strålin, MD
Email
karin.belander-stralin@karolinska.se
Facility Name
Dept of Pediatrics, Norrlands University Hospital
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrika Norén-Nyström, MD, PhD
Email
Ulrika.norennystrom@pediatri.umu.se
Facility Name
Dept of Pediatrics, Akademiska barnsjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Josefine Palle, MD, PhD
Email
josefine.palle@akademiska.se
12. IPD Sharing Statement
Learn more about this trial
Research Study for Treatment of Children and Adolescents With Acute Myeloid Leukaemia 0-18 Years
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