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JOURNAL ONKOLOGIE – STUDIE
VIALE-T

A Study Evaluating Safety and Efficacy of Venetoclax in Combination With Azacitidine Versus Standard of Care After Allogeneic Stem Cell Transplantation (SCT) in Participants With Acute Myeloid Leukemia (AML)

Rekrutierend

NCT-Nummer:
NCT04161885

Studienbeginn:
Februar 2020

Letztes Update:
14.07.2021

Wirkstoff:
Venetoclax, azacitidine

Indikation (Clinical Trials):
Leukemia, Leukemia, Myeloid, Leukemia, Myeloid, Acute

Geschlecht:
Alle

Altersgruppe:
Alle

Phase:
Phase 3

Sponsor:
AbbVie

Collaborator:
-

Studienleiter

ABBVIE INC.
Study Director
AbbVie

Kontakt

Studienlocations
(3 von 129)

Universitaetsklinik Heidelberg /ID# 216623
69120 Heidelberg
(Baden-Württemberg)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Muenster /ID# 215213
48149 Muenster
(Nordrhein-Westfalen)
GermanyNoch nicht rekrutierend» Google-Maps
Universitaetsklinikum Carl Gustav Carus an der TU Dresden /ID# 214244
01307 Dresden
(Sachsen)
GermanyNoch nicht rekrutierend» Google-Maps
Medizinische Hochschule Hannover /ID# 214243
30625 Hannover
(Niedersachsen)
GermanyRekrutierend» Google-Maps
Universitaetsklinikum Wuerzburg /ID# 215212
97080 Wuerzburg
(Bayern)
GermanyNoch nicht rekrutierend» Google-Maps
University of Alabama at Birmingham - Main /ID# 214524
35233 Birmingham
United StatesNoch nicht rekrutierend» Google-Maps
City of Hope /ID# 213681
91010 Duarte
United StatesRekrutierend» Google-Maps
University of California, Los Angeles /ID# 218199
90095 Los Angeles
United StatesNoch nicht rekrutierend» Google-Maps
UCHSC Anschultz Cancer Pavilion /ID# 215618
80045-2517 Aurora
United StatesNoch nicht rekrutierend» Google-Maps
Colorado Blood Cancer Institute /ID# 215980
80218 Denver
United StatesNoch nicht rekrutierend» Google-Maps
AdventHealth Medical Group Blood & Marrow Transplant at Orlando /ID# 213985
32804-5505 Orlando
United StatesNoch nicht rekrutierend» Google-Maps
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 215840
60611 Chicago
United StatesRekrutierend» Google-Maps
The University of Chicago Medical Center /ID# 215616
60637-1443 Chicago
United StatesNoch nicht rekrutierend» Google-Maps
Loyola University Medical Ctr /ID# 215617
60153 Maywood
United StatesNoch nicht rekrutierend» Google-Maps
Indiana Blood & Marrow Transpl /ID# 215842
46237 Indianapolis
United StatesNoch nicht rekrutierend» Google-Maps
University of Kentucky Chandler Medical Center /ID# 214791
40536 Lexington
United StatesNoch nicht rekrutierend» Google-Maps
Ochsner Clinic Foundation-New Orleans /ID# 213834
70121 New Orleans
United StatesNoch nicht rekrutierend» Google-Maps
Greenebaum Comprehensive Cancer Center - UM /ID# 213855
21201-1544 Baltimore
United StatesNoch nicht rekrutierend» Google-Maps
Massachusetts General Hospital /ID# 215765
02114 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Beth Israel Deaconess Medical Center /ID# 221181
02215-5400 Boston
United StatesNoch nicht rekrutierend» Google-Maps
Karmanos Cancer Institute - Dresner Clinic /ID# 214581
48201-2013 Detroit
United StatesNoch nicht rekrutierend» Google-Maps
Mayo Clinic /ID# 214685
55905-0001 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
The John Theurer Cancer /ID# 215251
07601 Hackensack
United StatesNoch nicht rekrutierend» Google-Maps
Roswell Park Comprehensive Cancer Center /ID# 217857
14263 Buffalo
United StatesNoch nicht rekrutierend» Google-Maps
Weill Cornell Medical College /ID# 214887
10065 New York
United StatesNoch nicht rekrutierend» Google-Maps
Univ Rochester Med Ctr /ID# 215877
14642 Rochester
United StatesNoch nicht rekrutierend» Google-Maps
University of North Carolina /ID# 215814
27514 Chapel Hill
United StatesNoch nicht rekrutierend» Google-Maps
University of Oklahoma, Stephenson Cancer Center /ID# 215611
73104-5418 Oklahoma City
United StatesNoch nicht rekrutierend» Google-Maps
Oregon Health & Science University /ID# 215874
97239 Portland
United StatesNoch nicht rekrutierend» Google-Maps
Penn State Hershey Medical Ctr /ID# 217120
17033 Hershey
United StatesNoch nicht rekrutierend» Google-Maps
Children's Hospital of Philadelphia - Main /ID# 215410
19104-4319 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Perelman Center for Advanced Medicine - /ID# 214518
19104-5127 Philadelphia
United StatesNoch nicht rekrutierend» Google-Maps
Allegheny General Hospital /ID# 216756
15212 Pittsburgh
United StatesNoch nicht rekrutierend» Google-Maps
UPMC Hillman Cancer Ctr /ID# 213715
15232 Pittsburgh
United StatesRekrutierend» Google-Maps
St Jude Children's Research Hospital /ID# 214074
38105 Memphis
United StatesNoch nicht rekrutierend» Google-Maps
TriStar Centennial Medical Center /ID# 218750
37203-1551 Nashville
United StatesRekrutierend» Google-Maps
Texas Oncology - Medical City Dallas /ID# 216720
75230 Dallas
United StatesNoch nicht rekrutierend» Google-Maps
Texas Oncology- Baylor Charles A. Sammons Cancer Center /ID# 213735
75246-2003 Dallas
United StatesNoch nicht rekrutierend» Google-Maps
Texas Transplant Institute /ID# 214691
78229 San Antonio
United StatesNoch nicht rekrutierend» Google-Maps
Fred Hutchinson Cancer Research Center /ID# 214436
98109-1024 Seattle
United StatesRekrutierend» Google-Maps
Univ of Wisconsin Hosp/Clinics /ID# 216096
53792-0001 Madison
United StatesNoch nicht rekrutierend» Google-Maps
St. Vincent's Hospital, Darlinghurst /ID# 214660
2010 Darlinghurst
AustraliaRekrutierend» Google-Maps
Royal Adelaide Hospital /ID# 215678
5000 Adelaide
AustraliaNoch nicht rekrutierend» Google-Maps
Peter MacCallum Cancer Centre /ID# 214653
3000 Melbourne
AustraliaNoch nicht rekrutierend» Google-Maps
Hospital de Clinicas de Porto Alegre /ID# 215042
90035-903 Porto Alegre
BrazilNoch nicht rekrutierend» Google-Maps
Hospital Amaral Carvalho /ID# 215145
17210-070 Jaú
BrazilNoch nicht rekrutierend» Google-Maps
Vancouver Coastal Health Research Institute (VCHRI) /ID# 215363
V5Z 1M9 Vancouver
CanadaNoch nicht rekrutierend» Google-Maps
Princess Margaret Cancer Centre /ID# 215344
M5G 2M9 Toronto
CanadaNoch nicht rekrutierend» Google-Maps
CIUSSS de l'est de l'Ile-de-Montreal - Hopital Maisonneuve-Rosemont /ID# 214591
H1T 2M4 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Montreal General Hospital - McGill University Health Center /ID# 215253
H3G 1A4 Montreal
CanadaNoch nicht rekrutierend» Google-Maps
Anhui Provincial Hospital /ID# 216408
230001 Hefei
ChinaNoch nicht rekrutierend» Google-Maps
Peking University People's Hospital /ID# 215551
100044 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Chinese PLA General Hospital /ID# 216287
100853 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Aerospace Center Hospital /ID# 217018
861059 Beijing
ChinaNoch nicht rekrutierend» Google-Maps
Fujian Medical University Union Hospital /ID# 215555
350001 Fuzhou
ChinaNoch nicht rekrutierend» Google-Maps
Guangdong Provincial People's Hospital /ID# 218666
510080 Guangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Henan Cancer Hospital /ID# 215554
450008 Zhengzhou
ChinaNoch nicht rekrutierend» Google-Maps
Tongji Hospital Tongji Medical College Huazhong University of Science and Techno /ID# 215552
430022 Wuhan
ChinaNoch nicht rekrutierend» Google-Maps
Zhongda Hospital Southeast University /ID# 218926
210009 Nanjing
ChinaNoch nicht rekrutierend» Google-Maps
Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 216410
200025 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Shanghai Changhai Hospital /ID# 216334
200433 Shanghai
ChinaNoch nicht rekrutierend» Google-Maps
Tangdu Hospital /ID# 216282
710038 Xian
ChinaNoch nicht rekrutierend» Google-Maps
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sc /ID# 215546
300020 Tianjin
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital, Zhejiang University School of Medicine /ID# 215550
310006 Hangzhou
ChinaNoch nicht rekrutierend» Google-Maps
Xiangya Hospital Central South University /ID# 219025
410008 Changsha
ChinaNoch nicht rekrutierend» Google-Maps
Nanfang Hospital of Southern Medical University /ID# 215553
510080 Guangzhou
ChinaNoch nicht rekrutierend» Google-Maps
The First Affiliated Hospital of Soochow University /ID# 216605
215006 Soochow
ChinaNoch nicht rekrutierend» Google-Maps
Fakultni Nemocnice Brno /ID# 214811
625 00 Brno
CzechiaNoch nicht rekrutierend» Google-Maps
Fakultni nemocnice Hradec Kralove /ID# 214814
500 05 Hradec Kralove
CzechiaNoch nicht rekrutierend» Google-Maps
Ustav hematologie a krevni transfuze /ID# 215133
128 00 Praha
CzechiaNoch nicht rekrutierend» Google-Maps
Hopital Haut-Lévêque /ID# 214055
33604 Pessac CEDEX
FranceNoch nicht rekrutierend» Google-Maps
CHRU Lille - Hopital Claude Huriez /ID# 217916
59045 Lille CEDEX
FranceNoch nicht rekrutierend» Google-Maps
CHU de Nantes, Hotel Dieu -HME /ID# 214060
44093 Nantes
FranceNoch nicht rekrutierend» Google-Maps
Hopital lArchet 2 /ID# 214056
06202 Nice
FranceNoch nicht rekrutierend» Google-Maps
AP-HP - Hopital Saint-Antoine /ID# 216957
75012 Paris
FranceNoch nicht rekrutierend» Google-Maps
Hopital Saint Louis /ID# 214054
75475 Paris
FranceNoch nicht rekrutierend» Google-Maps
Rambam Health Care Campus /ID# 214507
3109601 Haifa
IsraelRekrutierend» Google-Maps
Hadassah Medical Center /ID# 218697
9112001 Jerusalem
IsraelRekrutierend» Google-Maps
Schneider Children's Medical Center /ID# 224326
4920235 Petah Tikva
IsraelNoch nicht rekrutierend» Google-Maps
Rabin Medical Center /ID# 214509
4941492 Petakh Tikva
IsraelRekrutierend» Google-Maps
Sheba Medical Center /ID# 214305
5239424 Ramat Gan
IsraelRekrutierend» Google-Maps
Tel Aviv Medical Center /ID# 214508
64239 Tel Aviv
IsraelRekrutierend» Google-Maps
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 214910
00168 Rome
ItalyNoch nicht rekrutierend» Google-Maps
Ospedale San Raffaele IRCCS /ID# 214311
20132 Milan
ItalyNoch nicht rekrutierend» Google-Maps
ASST Spedali civili di Brescia /ID# 215997
25123 Brescia
ItalyNoch nicht rekrutierend» Google-Maps
A.O.U. Citta della Salute e della Scienza di Torino /ID# 216148
10126 Turin
ItalyNoch nicht rekrutierend» Google-Maps
Anjou Kousei Hospital /ID# 215857
446-8602 Anjo-shi
JapanNoch nicht rekrutierend» Google-Maps
Nagoya University Hospital /ID# 215679
453-8511 Nagoya-shi
JapanRekrutierend» Google-Maps
Kyushu University Hospital /ID# 215285
812-8582 Fukuoka-shi
JapanNoch nicht rekrutierend» Google-Maps
Hokkaido University Hospital /ID# 215937
060-8648 Sapporo-shi
JapanRekrutierend» Google-Maps
Duplicate_Shinsuma General Hospital /ID# 215388
6540047 Kobe-shi
JapanNoch nicht rekrutierend» Google-Maps
Hyogo College of Medicine College Hospital /Id# 215389
663-8501 Nishinomiya-shi
JapanNoch nicht rekrutierend» Google-Maps
Shin-Yurigaoka General Hospital /ID# 215688
2150026 Kawasaki City
JapanNoch nicht rekrutierend» Google-Maps
Kanagawa Cancer Center /ID# 215029
241-8515 Yokohama-shi
JapanNoch nicht rekrutierend» Google-Maps
Tohoku Rosai Hospital /ID# 214670
981-8563 Sendai-shi
JapanNoch nicht rekrutierend» Google-Maps
Okayama University Hospital /ID# 214842
700-8558 Okayama-shi
JapanRekrutierend» Google-Maps
Osaka City University Hospital /ID# 215227
545-8586 Osaka-shi
JapanRekrutierend» Google-Maps
Kindai University Hospital /ID# 214917
589-8511 Osakasayama-shi
JapanRekrutierend» Google-Maps
Jichi Medical University Saitama Medical Center /ID# 216092
330-8503 Saitama-shi
JapanNoch nicht rekrutierend» Google-Maps
Jichi Children's Medical Center Tochigi /ID# 216091
329-0431 Shimotsuke-shi
JapanRekrutierend» Google-Maps
Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital /ID# 215939
113-8677 Bunkyo-ku
JapanNoch nicht rekrutierend» Google-Maps
The Catholic University of Korea, Seoul St. Mary's Hospital /ID# 214892
06591 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Seoul National University Hospital /ID# 214891
03080 Seoul
Korea, Republic ofRekrutierend» Google-Maps
Asan Medical Center /ID# 214893
05505 Seoul
Korea, Republic ofNoch nicht rekrutierend» Google-Maps
Rogachev Nat Med Research Ctr for Pediatric Hematology, Onc /ID# 216538
117198 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Academician I.P. Pavlov First St. Petersburg State Medical University /ID# 214609
197101 St. Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Kirov Research Institute of Hematology and Blood Transfusion of FMBA /ID# 216591
610027 Kirov
Russian FederationNoch nicht rekrutierend» Google-Maps
Federal State Budget Inst. /ID# 214355
125167 Moscow
Russian FederationNoch nicht rekrutierend» Google-Maps
Federal Almazov N-W Med Res /ID# 214357
197341 St. Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
N.N. Petrov Research Institute of Oncology /ID# 216691
197758 St. Petersburg
Russian FederationNoch nicht rekrutierend» Google-Maps
Hospital Clinic de Barcelona /ID# 215108
08036 Barcelona
SpainRekrutierend» Google-Maps
Hospital General Universitario Gregorio Maranon /ID# 215107
28007 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Ramon y Cajal /ID# 218102
28034 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario La Paz /ID# 218103
28046 Madrid
SpainNoch nicht rekrutierend» Google-Maps
Hospital Universitario Virgen del Rocio /ID# 215463
41013 Sevilla
SpainNoch nicht rekrutierend» Google-Maps
Hospital Clinico Universitario de Valencia /ID# 215106
46010 Valencia
SpainNoch nicht rekrutierend» Google-Maps
Universitätsspital Basel /ID# 215892
4031 Basel
SwitzerlandRekrutierend» Google-Maps
Universitätsspital Zürich /ID# 215891
8091 Zürich
SwitzerlandRekrutierend» Google-Maps
National Taiwan University Hospital /ID# 215245
10002 Taipei City
TaiwanRekrutierend» Google-Maps
Kaohsiung Medical University Chung-Ho Memorial Hospital /ID# 215197
807 Kaohsiung
TaiwanRekrutierend» Google-Maps
China Medical University Hosp /ID# 215198
40447 Taichung City
TaiwanRekrutierend» Google-Maps
Linkou Chang Gung Memorial Ho /ID# 215319
333 Taoyuan City
TaiwanRekrutierend» Google-Maps
Queen Elizabeth University Hos /ID# 215663
G51 4TF Glasgow
United KingdomNoch nicht rekrutierend» Google-Maps
University Hospital Birmingham NHS Foudation Trust /ID# 215120
B15 2TH Birmingham
United KingdomNoch nicht rekrutierend» Google-Maps
UCLH, University College Hospi /ID# 215662
NW1 2PG London
United KingdomNoch nicht rekrutierend» Google-Maps
King's College Hospital NHS Foundation Trust /ID# 215338
SE5 9RS London
United KingdomNoch nicht rekrutierend» Google-Maps
Imperial College Healthcare NHS Trust /ID# 215665
W12 0HS London
United KingdomNoch nicht rekrutierend» Google-Maps
Manchester Royal Infirmary /ID# 215121
M13 9WL Manchester
United KingdomNoch nicht rekrutierend» Google-Maps
The Royal Marsden NHS Foundation Trust, Surrey /ID# 215124
SM2 5PT Surrey
United KingdomNoch nicht rekrutierend» Google-Maps
Alle anzeigen

Studien-Informationen

Brief Summary:

The main objective of this study is to evaluate the efficacy of venetoclax in combination

with azacitidine to improve Relapse Free Survival (RFS) in AML patients compared to Best

Supportive Care (BSC) when given as maintenance therapy following allogeneic stem cell

transplantation (SCT).

This study will have 2 parts: Part 1 (Dose Confirmation), which may include participants who

are greater than or equal to 18 years old; Part 2 (Randomization) which may include

participants who are greater than or equal to 12 years old. During Part 1, recommended Phase

3 dose of venetoclax in combination with azacitidine will be determined and during Part 2,

the efficacy and safety of venetoclax with azacitidine (Part 2 Arm A) will be compared with

BSC (Part 2 Arm B).

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Participants must be at least 18 years old for Part 1 and, at least 12 years old for

Part 2.

- Participant must be diagnosed with AML by World Health Organization (WHO) criteria

(2017) and either be planning for allogeneic stem cell transplantation or have

received allogeneic stem cell transplantation within the past 14 days.

- Blast percentage in bone marrow before transplant must be < 10%.

- Blast count in peripheral blood must be "0" and Blast percentage in bone marrow must

be < 5% after transplant.

- Participant meet adequate renal, hepatic and hematologic criteria as described in the

protocol.

- Participants >= 17 years old must have a Karnofsky Performance Scale (KPS) score > 50

and participants between 12 to 16 years old must have a Lansky Play Performance Scale

score > 40.

Exclusion Criteria:

- History of disease progression during prior treatment with venetoclax.

- History of any other malignancy within 2 years prior to study entry, except for:

Adequately treated in situ carcinoma of the cervix uteri or carcinoma in situ of

breast; basal cell carcinoma of the skin or localized squamous cell carcinoma of the

skin; previous malignancy confined and surgically resected (or treated with other

modalities) with curative intent; Myelodysplastic Syndrome.

- Participant has known infection with HIV or history of being positive for hepatitis B

virus (HBV) or hepatitis C virus (HCV) infection.

- Presence of clinical or laboratory symptoms/signs of extramedullary myeloid

malignancy.

Studien-Rationale

Primary outcome:

1. Number of Participants With Dose-Limiting Toxicities (DLTs) Following Administration of Venetoclax and Azacitidine (Part 1) (Time Frame - Upto the first treatment cycle (28 days)):
DLTs are any of the hematologic, nonhematologic toxicities, adverse events (AEs) occurring following administration of venetoclax and AZA as described in the protocol and evaluated by the Investigator and the sponsor.

2. Relapse-Free Survival (RFS) (Part 2) (Time Frame - Up to 39 months after the first participant is randomized):
RFS is defined as the number of days from randomization to the date of relapse or the date of death from any cause, whichever comes first.

Secondary outcome:

1. Overall Survival (OS) (Part 2) (Time Frame - Up to 45 months after the first participant is randomized):
OS is defined as the number of days from the date of randomization to the date of death from any cause.

2. Graft-versus-Host Disease (GvHD)-free, Relapse Free Survival (GRFS) (Part 2) (Time Frame - Up to 39 months after the first participant is randomized):
GRFS is defined as number of days from the date of randomization to occurrence of disease relapse OR occurrence or worsening of GvHD OR death from any cause.

3. Time to Deterioration in Global Health Status (GHS)/Quality of Life (QoL) in Adult Participants (Part 2) (Time Frame - Up to 39 months after the first participant is randomized):
Time to deterioration defined as number of days from randomization to either deterioration of >= 5 points based on the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) version 3 or death due to any cause.

4. Graft-versus-Host Disease (GvHD) rate (Part 2) (Time Frame - Up to 39 months after the first participant is randomized):
GvHD rate is defined as grade 2 or higher for acute graft-versus-host disease (aGvHD) and moderate/severe for chronic graft-versus-host disease (cGvHD) assessed by investigator

5. Change From Randomization in Fatigue in Adult Participants (Part 2) (Time Frame - Up to 39 months after the first participant is randomized):
Fatigue is measured as Patient Reported Outcome (PRO) using Patient Reported Outcomes Measurement Information System (PROMIS) Cancer Fatigue SF 7a.

6. Minimal Residual Disease (MRD) Response Rate in Participants With MRD >= 10^-3 at Randomization (Part 2) (Time Frame - Up to 39 months after the first participant is randomized):
MRD conversion rate is defined as percentage of participants who convert to MRD < 10^-3 after initiation of treatment.

Studien-Arme

  • Experimental: Part 1: Venetoclax + Azacitidine (AZA) + Best Supportive Care
    Participants will be administered various doses and dose regiments of venetoclax and AZA. Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days)
  • Experimental: Part 2: Arm A - Venetoclax + Azacitidine (AZA) + BSC
    Participants will be administered with venetoclax and AZA at a dose level determined in Part 1 in addition to best supportive care (when required). Venetoclax will be administered once daily (QD) (Days 1-28) for up to 24 cycles, AZA QD on Days 1-5 of each 28-day cycle for up to 6 cycles and best supportive care (BSC) for 24 cycles (each cycle = 28 days).
  • Experimental: Part 2: Arm B - Best Supportive Care (BSC)
    Participants will receive treatment as prescribed by their physician according to the BSC for up to 24 cycles (1 cycle = 28 days)

Geprüfte Regime

  • Venetoclax (ABT-199 / GDC-0199 / VENCLEXTA / ):
    Tablet; Oral
  • Azacitidine:
    Subcutaneous (SC) or intravenous (IV) injection
  • Best Supportive Care (BSC):
    BSC is the best supportive care, without AML directed therapy, determined per the investigator and institutional guidelines.

Quelle: ClinicalTrials.gov


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