Back to resultsDAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Primary Purpose
Low-grade Glioma
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
DAY101
Chemotherapeutic Agent
Sponsored by
About this trial
This is an interventional treatment trial for Low-grade Glioma
Eligibility Criteria
Inclusion Criteria:
- Less than 25 years of age with LGG with known activating RAF alteration
- Histopathologic diagnosis of glioma or glioneuronal tumor
- At least one measurable lesion as defined by RANO criteria
- Meet indication for first-line systemic therapy
Exclusion Criteria:
Patient has any of the following tumor-histological findings:
- Schwannoma
- Subependymal giant cell astrocytoma (Tuberous Sclerosis)
- Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
- Patient's tumor has additional activating molecular alterations
- Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF-1/NF-2)
- Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/intravenous targeted therapy) including radiation
Sites / Locations
- Children's of AlabamaRecruiting
- Phoenix Children's HospitalRecruiting
- Children's Hospital Los AngelesRecruiting
- Children's Hospital ColoradoRecruiting
- Children's National Medical CenterRecruiting
- Arnold Palmer Hospital for ChildrenRecruiting
- Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
- Riley Hospital for Children at Indiana University HealthRecruiting
- Dana-Farber Cancer InstituteRecruiting
- University of Michigan - - C.S. Mott Children's HospitalRecruiting
- St. Louis Children's HospitalRecruiting
- New York University Langone HealthRecruiting
- University of RochesterRecruiting
- Duke Cancer InstituteRecruiting
- University of Texas Southwestern Medical CenterRecruiting
- Texas Children's HospitalRecruiting
- Perth Children's HospitalRecruiting
- Women's and Children's Health NetworkRecruiting
- The Royal Children's Hospital - Children's Cancer CentreRecruiting
- Sydney Children's Hospital - RandwickRecruiting
- Children's Hospital at WestmeadRecruiting
- Medizinische Universität WienRecruiting
- Cliniques Universitaires Saint-LucRecruiting
- Universitair Ziekenhuis GentRecruiting
- Universitair Ziekenhuis Leuven - Campus GasthuisbergRecruiting
- CHU Sainte-JustineRecruiting
- The Montreal Children's HospitalRecruiting
- Centre Hospitalier de l'Université Laval et Centre Mère-Enfant SoleilRecruiting
- SickKids - The Hospital for Sick ChildrenRecruiting
- Fakultní Nemocnice Brno - D?tská NemocniceRecruiting
- Motol University HospitalRecruiting
- RigshospitaletRecruiting
- Helsingin yliopistollinen sairaala (HUS)Recruiting
- Tampereen Yliopistollinen SairaalaRecruiting
- Hôpital de la TimoneRecruiting
- Institut CurieRecruiting
- Gustave RoussyRecruiting
- Charité Universitätsmedizin BerlinRecruiting
- Evangelische Klinikum Bethel (EvKB)Recruiting
- Universitätsklinikum Hamburg-EppendorfRecruiting
- Universitätsklinikum HeidelbergRecruiting
- Universitätsklinikum TübingenRecruiting
- Universitätsklinikum ErlangenRecruiting
- Aghia Sofia General Children's HospitalRecruiting
- Athens General Children's HospitalRecruiting
- Semmelweis Egyetem Tűzoltó utcai II. Sz. Gyermekgyógyászati KlinikáRecruiting
- Azienda Ospedaliera di Rilievo Nazional Santobono PausiliponRecruiting
- Azienda Ospedale Università di PadovaRecruiting
- Seoul National University HospitalRecruiting
- Severance HospitalRecruiting
- Prinses Maxima Centrum KinderoncologieRecruiting
- Starship Paediatric Blood & Cancer CenterRecruiting
- SingHealth Group - KK Women's and Children's HospitalRecruiting
- Univerzitetni Klinini Center LjubljanaRecruiting
- Hospital Universitari Vall d'HebrónRecruiting
- Hospital Sant Joan de Déu BarcelonaRecruiting
- Hospital Infantil Universitario Niño JesúsRecruiting
- Hospital Universitario La PazRecruiting
- Hospital Universitario Virgen del RocíoRecruiting
- Hospital Universitari i Politècnic La FeRecruiting
- Drottning Silvias barn- och ungdomssjukhusRecruiting
- Astrid Lindgrens Barnsjukhus SolnaRecruiting
- Centre Hospitalier Universitaire Vaudois LausanneRecruiting
- Universitaets - Kinderspital ZürichRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Arm #1
Arm #2
Arm Description
DAY101
Investigator's choice of one of the following current standard of care for pediatric patients with low-grade gliomas: Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) Vinblastine (VBL)
Outcomes
Primary Outcome Measures
Compare the objective response rate (ORR) assessed per RANO criteria by independent review committee (IRC) of DAY101 monotherapy versus standard of care (SoC) chemotherapy
ORR, per RANO criteria, defined as the proportion of patients with overall confirmed response of complete response (CR) or partial response (PR)
Secondary Outcome Measures
Compare the progression-free survival (PFS) assessed by IRC of DAY101 monotherapy versus SoC chemotherapy per RANO criteria
PFS per RANO criteria, defined as time from randomization to PD or death from any cause
Compare the duration of response (DOR) assessed by IRC of DAY101 monotherapy versus SoC chemotherapy per RANO criteria
DOR per RANO criteria, defined as time from confirmed response to PD or death from any cause for patients with confirmed response
Compare the overall survival (OS) of DAY101 monotherapy versus SoC chemotherapy
OS, defined as time from randomization up to death from any cause
Compare the safety and tolerability of DAY101 monotherapy versus SoC chemotherapy
Type, frequency, and severity of treatment-emergent adverse events
Compare the safety and tolerability of DAY101 monotherapy versus SoC chemotherapy
Measured by incidence of clinically significant laboratory abnormalities
Compare changes in neurological function between DAY101 versus SoC
Change from baseline in the Vineland Adaptive Behavior Composite Scales [age-adjusted standard scores range between 20 to 140, with a mean of 100 and standard deviation of 15, and lower scores indicate worse functional outcomes]
Compare changes in visual function outcomes of DAY101 monotherapy versus SoC chemotherapy in patients with optic pathway glioma (OPG)
Measured by Teller Acuity Cards® or alternative
Compare the ORR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO criteria
ORR, defined as the proportion of patients with overall confirmed response per RANO
Compare the ORR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria
ORR, defined as the proportion of patients with overall confirmed response per RAPNO
Compare the clinical benefit rate (CBR) of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO and RAPNO criteria
CBR, defined as the proportion of patients with radiological tumor stabilization or regression per RANO or RAPNO criteria, as applicable
Compare time to response (TTR) of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO and RAPNO criteria
Measured by the time to first response following initiation of therapy in patients with best overall confirmed response per RANO or RAPNO criteria, as applicable
Compare the PFS of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO and RANO criteria
PFS per RANO or RAPNO (as applicable), defined as time from randomization to progressive disease (PD) or death from any cause
Compare the DOR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO and RANO criteria
DOR, defined as time from confirmed response to PD or death from any cause for patients with confirmed response per RANO or RAPNO criteria, as applicable
Full Information
NCT ID
NCT05566795
First Posted
September 16, 2022
Last Updated
October 16, 2023
Sponsor
Day One Biopharmaceuticals, Inc.
Collaborators
SIOPe Brain Tumor Group LOGGIC Consortium
1. Study Identification
Unique Protocol Identification Number
NCT05566795
Brief Title
DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Official Title
LOGGIC/FIREFLY-2: A Phase 3, Randomized, International Multicenter Trial of DAY101 Monotherapy Versus Standard of Care Chemotherapy in Patients With Pediatric Low-Grade Glioma Harboring an Activating RAF Alteration Requiring First-Line Systemic Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 27, 2023 (Actual)
Primary Completion Date
February 2026 (Anticipated)
Study Completion Date
March 2030 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Day One Biopharmaceuticals, Inc.
Collaborators
SIOPe Brain Tumor Group LOGGIC Consortium
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a 2-arm, randomized, open-label, multicenter, global, Phase 3 trial to evaluate the efficacy, safety, and tolerability of DAY101 monotherapy versus standard of care (SoC) chemotherapy in patients with pediatric low-grade glioma (LGG) harboring an activating rapidly accelerated fibrosarcoma (RAF) alteration requiring front-line systemic therapy.
Detailed Description
Approximately 400 treatment-naïve low-grade glioma patients will be randomized 1:1 to either DAY101 (Arm 1) or an Investigator's choice of SoC chemotherapy (Arm 2).
Arm 1 (DAY101): treatment cycles will repeat every 28 days in the absence of disease progression. Patients will continue DAY101 until any of the following occurs: radiographic progression based on Response Assessment in Neuro-Oncology (RANO) criteria as determined by the Investigator and confirmed by the Independent Review Committee (IRC), unacceptable toxicity, withdrawal of consent to treatment, or end of study.
Arm 2 (Investigator's Choice of SoC Chemotherapy): patients will receive one of 3 SoC chemotherapy options selected by the treating Investigator: Children's Oncology Group - Vincristine/Carboplatin (COG-V/C) regimen, International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C) regimen, or vinblastine (VBL) regimen. The choice of SoC chemotherapy regimen will be selected prior to patient randomization. Treatment will continue until completion of therapy or until any of the following occurs: radiographic progression based on RANO criteria as determined by the Investigator and confirmed by the IRC, unacceptable toxicity, withdrawal of consent to treatment, or end of study.
During treatment phase, patients who demonstrate radiographic progression per RANO criteria as determined by the Investigator and confirmed by IRC in Arm 1 (DAY101) may be allowed to continue DAY101 if, in the opinion of the Investigator, the patient is deriving clinical benefit from continuing study treatment and approved by the Sponsor. Patients who demonstrate radiographic progression per RANO criteria as determined by the Investigator and confirmed by IRC during the treatment phase in Arm 2 (SoC chemotherapy) and discontinue treatment may be eligible to receive DAY101 at the same treatment and assessment schedule. In addition, Arm 2 patients who demonstrate radiographic progression after completion of chemotherapy [ie, during long-term follow-up (LTFU)] may be eligible to receive DAY101.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low-grade Glioma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
DAY101 versus standard of care chemotherapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm #1
Arm Type
Experimental
Arm Description
DAY101
Arm Title
Arm #2
Arm Type
Active Comparator
Arm Description
Investigator's choice of one of the following current standard of care for pediatric patients with low-grade gliomas:
Children's Oncology Group - Vincristine/Carboplatin (COG-V/C)
International Society for Paediatric Oncology - Low-Grade Glioma Vincristine/Carboplatin (SIOPe-LGG-V/C)
Vinblastine (VBL)
Intervention Type
Drug
Intervention Name(s)
DAY101
Other Intervention Name(s)
tovorafenib
Intervention Description
Oral pan-RAF inhibitor
Intervention Type
Drug
Intervention Name(s)
Chemotherapeutic Agent
Other Intervention Name(s)
COG-V/C, SIOPe-LGG-V/C, VBL
Intervention Description
Intravenous solution for injection
Primary Outcome Measure Information:
Title
Compare the objective response rate (ORR) assessed per RANO criteria by independent review committee (IRC) of DAY101 monotherapy versus standard of care (SoC) chemotherapy
Description
ORR, per RANO criteria, defined as the proportion of patients with overall confirmed response of complete response (CR) or partial response (PR)
Time Frame
Up to 60 months
Secondary Outcome Measure Information:
Title
Compare the progression-free survival (PFS) assessed by IRC of DAY101 monotherapy versus SoC chemotherapy per RANO criteria
Description
PFS per RANO criteria, defined as time from randomization to PD or death from any cause
Time Frame
Up to 60 months
Title
Compare the duration of response (DOR) assessed by IRC of DAY101 monotherapy versus SoC chemotherapy per RANO criteria
Description
DOR per RANO criteria, defined as time from confirmed response to PD or death from any cause for patients with confirmed response
Time Frame
Up to 60 months
Title
Compare the overall survival (OS) of DAY101 monotherapy versus SoC chemotherapy
Description
OS, defined as time from randomization up to death from any cause
Time Frame
Up to 60 months
Title
Compare the safety and tolerability of DAY101 monotherapy versus SoC chemotherapy
Description
Type, frequency, and severity of treatment-emergent adverse events
Time Frame
Up to 60 months
Title
Compare the safety and tolerability of DAY101 monotherapy versus SoC chemotherapy
Description
Measured by incidence of clinically significant laboratory abnormalities
Time Frame
Up to 60 months
Title
Compare changes in neurological function between DAY101 versus SoC
Description
Change from baseline in the Vineland Adaptive Behavior Composite Scales [age-adjusted standard scores range between 20 to 140, with a mean of 100 and standard deviation of 15, and lower scores indicate worse functional outcomes]
Time Frame
Up to 60 months
Title
Compare changes in visual function outcomes of DAY101 monotherapy versus SoC chemotherapy in patients with optic pathway glioma (OPG)
Description
Measured by Teller Acuity Cards® or alternative
Time Frame
Up to 60 months
Title
Compare the ORR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO criteria
Description
ORR, defined as the proportion of patients with overall confirmed response per RANO
Time Frame
Up to 60 months
Title
Compare the ORR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per Response Assessment in Pediatric Neuro-Oncology (RAPNO) criteria
Description
ORR, defined as the proportion of patients with overall confirmed response per RAPNO
Time Frame
Up to 60 months
Title
Compare the clinical benefit rate (CBR) of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO and RAPNO criteria
Description
CBR, defined as the proportion of patients with radiological tumor stabilization or regression per RANO or RAPNO criteria, as applicable
Time Frame
Up to 60 months
Title
Compare time to response (TTR) of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RANO and RAPNO criteria
Description
Measured by the time to first response following initiation of therapy in patients with best overall confirmed response per RANO or RAPNO criteria, as applicable
Time Frame
Up to 60 months
Title
Compare the PFS of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO and RANO criteria
Description
PFS per RANO or RAPNO (as applicable), defined as time from randomization to progressive disease (PD) or death from any cause
Time Frame
Up to 60 months
Title
Compare the DOR of DAY101 monotherapy versus SoC chemotherapy as assessed by IRC per RAPNO and RANO criteria
Description
DOR, defined as time from confirmed response to PD or death from any cause for patients with confirmed response per RANO or RAPNO criteria, as applicable
Time Frame
Up to 60 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Less than 25 years of age with LGG with known activating RAF alteration
Histopathologic diagnosis of glioma or glioneuronal tumor
At least one measurable lesion as defined by RANO criteria
Meet indication for first-line systemic therapy
Exclusion Criteria:
Patient has any of the following tumor-histological findings:
Schwannoma
Subependymal giant cell astrocytoma (Tuberous Sclerosis)
Diffuse intrinsic pontine glioma, even if histologically diagnosed as World Health Organization (WHO) Grade I-II
Patient's tumor has additional activating molecular alterations
Known or suspected diagnosis of neurofibromatosis Type 1 or 2 (NF-1/NF-2)
Prior or ongoing nonsurgical anticancer therapy for this indication (eg, chemotherapy, oral/intravenous targeted therapy) including radiation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Day One Clinical Trials Information
Phone
650-484-0899
Email
clinicaltrials@dayonebio.com
Facility Information:
Facility Name
Children's of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Arnold Palmer Hospital for Children
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Name
Riley Hospital for Children at Indiana University Health
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Michigan - - C.S. Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
New York University Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Name
Duke Cancer Institute
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Recruiting
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
Perth Children's Hospital
City
Nedlands
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Recruiting
Facility Name
Women's and Children's Health Network
City
North Adelaide
ZIP/Postal Code
5006
Country
Australia
Individual Site Status
Recruiting
Facility Name
The Royal Children's Hospital - Children's Cancer Centre
City
Parkville
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Sydney Children's Hospital - Randwick
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Recruiting
Facility Name
Children's Hospital at Westmead
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Brussel
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Gent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Universitair Ziekenhuis Leuven - Campus Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU Sainte-Justine
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T IC5
Country
Canada
Individual Site Status
Recruiting
Facility Name
The Montreal Children's Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier de l'Université Laval et Centre Mère-Enfant Soleil
City
Québec
ZIP/Postal Code
G1V 4G2
Country
Canada
Individual Site Status
Recruiting
Facility Name
SickKids - The Hospital for Sick Children
City
Toronto
ZIP/Postal Code
M5G 1X8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Fakultní Nemocnice Brno - D?tská Nemocnice
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Motol University Hospital
City
Prague
ZIP/Postal Code
5 150 06
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Helsingin yliopistollinen sairaala (HUS)
City
Helsinki
ZIP/Postal Code
FI-00290
Country
Finland
Individual Site Status
Recruiting
Facility Name
Tampereen Yliopistollinen Sairaala
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Recruiting
Facility Name
Hôpital de la Timone
City
Marseille
ZIP/Postal Code
13005
Country
France
Individual Site Status
Recruiting
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Individual Site Status
Recruiting
Facility Name
Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France
Individual Site Status
Recruiting
Facility Name
Charité Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Individual Site Status
Recruiting
Facility Name
Evangelische Klinikum Bethel (EvKB)
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Erlangen
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Aghia Sofia General Children's Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Athens General Children's Hospital
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem Tűzoltó utcai II. Sz. Gyermekgyógyászati Kliniká
City
Budapest
ZIP/Postal Code
1094
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliera di Rilievo Nazional Santobono Pausilipon
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedale Università di Padova
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Prinses Maxima Centrum Kinderoncologie
City
Utrecht
ZIP/Postal Code
3584 CS
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Starship Paediatric Blood & Cancer Center
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Individual Site Status
Recruiting
Facility Name
SingHealth Group - KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Name
Univerzitetni Klinini Center Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebrón
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan de Déu Barcelona
City
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Infantil Universitario Niño Jesús
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari i Politècnic La Fe
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Drottning Silvias barn- och ungdomssjukhus
City
Göteborg
ZIP/Postal Code
416 85
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Astrid Lindgrens Barnsjukhus Solna
City
Stockholm
ZIP/Postal Code
171 77
Country
Sweden
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire Vaudois Lausanne
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Individual Site Status
Recruiting
Facility Name
Universitaets - Kinderspital Zürich
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Recruiting
12. IPD Sharing Statement
Learn more about this trial
DAY101 vs. Standard of Care Chemotherapy in Pediatric Patients With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
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