DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)

PHASE3RecruitingINTERVENTIONAL
Enrollment

400

Participants

Timeline

Start Date

February 27, 2023

Primary Completion Date

February 28, 2026

Study Completion Date

March 31, 2030

Conditions
Low-grade GliomaRapidly Accelerated Fibrosarcoma (RAF) Altered GliomaPediatric Low-grade Glioma
Interventions
DRUG

Tovorafenib

Oral Tablet Powder for Oral Suspension

DRUG

Chemotherapeutic Agent

Intravenous solution for injection

Trial Locations (132)

110

RECRUITING

Taipei Medical University Hospital, Taipei

333

RECRUITING

Chang Gung Memorial Hospital - Linkou Branch, Taoyuan District

372

RECRUITING

Oslo Universitetssykehus, Oslo

1000

RECRUITING

Univerzitetni Klinini Center Ljubljana, Ljubljana

1011

RECRUITING

Centre Hospitalier Universitaire Vaudois Lausanne, Lausanne

1023

RECRUITING

Starship Paediatric Blood & Cancer Center, Grafton

1090

RECRUITING

Medizinische Universität Wien, Vienna

1094

RECRUITING

Semmelweis Egyetem Tűzoltó utcai II. Sz. Gyermekgyógyászati Kliniká, Budapest

1200

RECRUITING

Cliniques Universitaires Saint-Luc, Brussels

2031

RECRUITING

Sydney Children's Hospital - Randwick, Randwick

2100

RECRUITING

Rigshospitalet, Copenhagen

2145

RECRUITING

Children's Hospital at Westmead, Westmead

3000

RECRUITING

Universitair Ziekenhuis Leuven - Campus Gasthuisberg, Leuven

3052

RECRUITING

The Royal Children's Hospital - Children's Cancer Centre, Parkville

4101

RECRUITING

Children's Health Queensland Hospital and Health Service, South Brisbane

4103

RECRUITING

Universitätsklinikum Leipzig, Leipzig

5006

RECRUITING

Women's and Children's Health Network, North Adelaide

6009

RECRUITING

Perth Children's Hospital, Nedlands

6020

RECRUITING

Medizinische Universität Innsbruck, Innsbruck

8032

RECRUITING

Universitaets - Kinderspital Zürich, Zurich

8200

RECRUITING

Aarhus Universitetshospital, Aarhus

9000

RECRUITING

Universitair Ziekenhuis Gent, Ghent

9038

RECRUITING

Universitetssykehuset Nord-Norge - Tromsø, Tromsø

10016

RECRUITING

New York University Langone Health, New York

10032

RECRUITING

Columbia University, New York

10126

RECRUITING

Ospedale Infantile Regina Margherita, Torino

11527

RECRUITING

Aghia Sofia General Children's Hospital, Athens

RECRUITING

Athens General Children's Hospital, Athens

11941

RECRUITING

King Hussein Cancer Foundation - King Hussein Cancer Center, Amman

12208

RECRUITING

Albany Medical Center, Albany

13005

RECRUITING

Hôpital de la Timone, Marseille

13353

RECRUITING

Charité Universitätsmedizin Berlin, Berlin

14642

RECRUITING

University of Rochester, Rochester

16147

RECRUITING

Istituto Giannina Gaslini, Genova

20010

RECRUITING

Children's National Medical Center, Washington D.C.

20133

RECRUITING

Fondazione IRCCS - Istituto Nazionale dei Tumori, Milan

20246

RECRUITING

Universitätsklinikum Hamburg-Eppendorf, Hamburg

27705

RECRUITING

Duke Cancer Institute, Durham

28009

RECRUITING

Hospital Infantil Universitario Niño Jesús, Madrid

28046

RECRUITING

Hospital Universitario La Paz, Madrid

30322

RECRUITING

Children's Healthcare of Atlanta, Atlanta

30625

RECRUITING

Medizinische Hochschule Hannover, Hanover

32610

RECRUITING

University of Florida Health, Gainesville

32806

RECRUITING

Arnold Palmer Hospital for Children, Orlando

33100

RECRUITING

Azienda Sanitaria Universitaria Friuli Centrale - P.O. Santa Maria della Misericordia, Udine

33520

RECRUITING

Tampereen Yliopistollinen Sairaala, Tampere

33617

RECRUITING

Evangelische Klinikum Bethel (EvKB), Bielefeld

33701

RECRUITING

Johns Hopkins All Children's Hospital, St. Petersburg

35128

RECRUITING

Azienda Ospedale Università di Padova, Padua

35233

RECRUITING

Children's of Alabama, Birmingham

40202

RECRUITING

Norton Children's Hospital, Louisville

41013

RECRUITING

Hospital Universitario Virgen del Rocío, Seville

44195

RECRUITING

Cleveland Clinic Main Campus, Cleveland

45147

RECRUITING

Universitaetsklinikum Essen, Essen

46026

RECRUITING

Hospital Universitari i Politècnic La Fe, Valencia

46202

RECRUITING

Riley Hospital for Children at Indiana University Health, Indianapolis

48109

RECRUITING

University of Michigan - - C.S. Mott Children's Hospital, Ann Arbor

48903

RECRUITING

Hospital Universitario Cruces, Barakaldo

49202

RECRUITING

Schneider Children's Medical Center of Israel, Petah Tikva

52242

RECRUITING

University of Iowa Hospitals Clinics, Iowa City

53792

RECRUITING

University of Wisconsin - Madison, Madison

55404

RECRUITING

Children's Minnesota, Minneapolis

59020

RECRUITING

Centre de Lutte contre le Cancer - Centre Oscar Lambret, Lille

60590

RECRUITING

Universitätsklinikum Frankfurt, Frankfurt am Main

60611

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago

60637

RECRUITING

University of Chicago, Chicago

63110

RECRUITING

St. Louis Children's Hospital, St Louis

69008

RECRUITING

Centre Léon Bérard, Lyon

69120

RECRUITING

Universitätsklinikum Heidelberg, Heidelberg

70124

RECRUITING

Azienda Universitaria Ospedaliera Consorziale - Policlinico di Bari, Bari

72076

RECRUITING

Universitätsklinikum Tübingen, Tübingen

75248

RECRUITING

Institut Curie, Paris

75390

RECRUITING

University of Texas Southwestern Medical Center, Dallas

77030

RECRUITING

Texas Children's Hospital, Houston

78723

RECRUITING

Dell Children's Medical Center of Central Texas, Austin

79106

RECRUITING

Universitätsklinikum Freiburg, Freiburg im Breisgau

80045

RECRUITING

Children's Hospital Colorado, Aurora

80131

RECRUITING

Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon, Napoli

85016

RECRUITING

Phoenix Children's Hospital, Phoenix

86156

RECRUITING

Universitätsklinikum Augsburg, Augsburg

90027

RECRUITING

Children's Hospital Los Angeles, Los Angeles

91054

RECRUITING

Universitätsklinikum Erlangen, Erlangen

92868

RECRUITING

Children's Hospital of Orange County Main Campus - Orange, Orange

94158

RECRUITING

UCSF Benioff Children's Hospital, San Francisco

94805

RECRUITING

Gustave Roussy, Villejuif

97080

RECRUITING

Universitätsklinikum Würzburg, Würzburg

97239

RECRUITING

Oregon Health Science University, Portland

98105

RECRUITING

Seattle Children's Hospital, Seattle

229899

RECRUITING

SingHealth Group - KK Women's and Children's Hospital, Singapore

5265601

RECRUITING

The Edmond and Lily Safra Children's Hospital, Ramat Gan

06106-3322

RECRUITING

Connecticut Children's Medical Center, Hartford

04074

RECRUITING

Maine Children's Cancer Program, Scarborough

02215

RECRUITING

Dana-Farber Cancer Institute, Boston

68198-6878

RECRUITING

University of Nebraska Medical Center, Omaha

04039-001

RECRUITING

Grupo de Apoio ao Adolescente e à Criança com Câncer (GRAACC), São Paulo

T3B 6A8

RECRUITING

Alberta Children's Hospital, Calgary

T6G 2B7

RECRUITING

Stollery Children's Hospital, Edmonton

V6H 3N1

RECRUITING

British Columbia Children's Hospital, Vancouver

L8S 4L8

RECRUITING

McMaster Children's Hospital, Hamilton

N6A 5W9

RECRUITING

Children's Hospital London Health Sciences Centre, London

K1H 8L1

RECRUITING

Children's Hospital of Eastern Ontario, Ottawa

H3T IC5

RECRUITING

CHU Sainte-Justine, Montreal

H4A 3J1

RECRUITING

The Montreal Children's Hospital, Montreal

G1V 4G2

RECRUITING

Centre Hospitalier de l'Université Laval et Centre Mère-Enfant Soleil, Québec

M5G 1X8

RECRUITING

SickKids - The Hospital for Sick Children, Toronto

625 00

RECRUITING

Fakultní Nemocnice Brno - D?tská Nemocnice, Brno

5 150 06

RECRUITING

Motol University Hospital, Prague

FI-00290

RECRUITING

Helsingin yliopistollinen sairaala (HUS), Helsinki

D12 N512

RECRUITING

Children's Health Ireland at Crumlin, Crumlin

00165

RECRUITING

Ospedale Pediatrico Bambino Gesù, Roma

3584 CS

RECRUITING

Prinses Maxima Centrum Kinderoncologie, Utrecht

03080

RECRUITING

Seoul National University Hospital, Seoul

03722

RECRUITING

Severance Hospital, Seoul

08035

RECRUITING

Hospital Universitari Vall d'Hebrón, Barcelona

08950

RECRUITING

Hospital Sant Joan de Déu Barcelona, Barcelona

416 85

RECRUITING

Drottning Silvias barn- och ungdomssjukhus, Gothenburg

221 85

RECRUITING

Skånes Universitetssjukhus - Lund, Lund

171 77

RECRUITING

Astrid Lindgrens Barnsjukhus Solna, Stockholm

B4 6NH

RECRUITING

Birmingham Women's and Children's NHS Foundation Trust, Birmingham

LS1 3EX

RECRUITING

Leeds Teaching Hospital NHS Trust, Leeds

L12 2AP

RECRUITING

Alder Hey Children's NHS Foundation Trust, Liverpool

M13 PWL

RECRUITING

Manchester University NHS Foundation Trust, Manchester

NE1 4LP

RECRUITING

The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne

WC1N 3JH

RECRUITING

Great Ormond Street Hospital for Children, Oxford

SO16 6YD

RECRUITING

University Hospital Southampton NHS Foundation Trust, Southampton

BT9 7AB

RECRUITING

Royal Belfast Hospital for Sick Children, Belfast

G51 4TF

RECRUITING

NHS Greater Glasgow and Clyde, Glasgow

S10 2TH

RECRUITING

Sheffield Children's Hospital, Sheffield

SM2 5PT

RECRUITING

The Royal Marsden NHS Foundation Trust, Sutton

BS2 8HW

RECRUITING

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol

CB2 0QQ

RECRUITING

Cambridge University Hospitals NHS Foundation Trust, Cambridge

M20 4BX

RECRUITING

The Christie Hospital, Manchester

All Listed Sponsors
collaborator

SIOPe Brain Tumor Group LOGGIC Consortium

UNKNOWN

lead

Day One Biopharmaceuticals, Inc.

INDUSTRY

NCT05566795 - DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) | Biotech Hunter | Biotech Hunter