Clinical trial • Phase II/III • Oncology

Human normal immunoglobulin (IV) for Langerhans Cell Histiocytosis

Phase II/III trial of Human normal immunoglobulin (IV) for Langerhans Cell Histiocytosis.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Langerhans Cell Histiocytosis
Trial Stage
Phase II/III
Drug Modality
Small molecule|Peptide/protein/enzyme|Monoclonal antibody
Paediatric Trial
Yes

Key dates

Initial CTIS Submission Date
27-08-2024
First CTIS Authorization Date
09-10-2024

Trial design

Randomised, randomized comparisons include continuation therapy options: indometacin versus 6-mercaptopurine/methotrexate (continuation therapy). there is also randomisation of continuation therapy duration (6 months vs 12 months). no specific drug doses/schedules for comparator arms are stated in the ctis metadata.-controlled, adaptive Phase II/III trial in Greece, Ireland, Italy and others.

Randomised
Yes
Comparator
Randomized comparisons include continuation therapy options: Indometacin versus 6-mercaptopurine/methotrexate (continuation therapy). There is also randomisation of continuation therapy duration (6 months vs 12 months). No specific drug doses/schedules for comparator arms are stated in the CTIS metadata.
Adaptive
True, protocol includes adaptive treatment decision rules (early switch to salvage treatment for patients with risk-organ involvement who do not respond to 1st-line therapy) and randomized intensification/extension strategies based on response.
Target Sample Size
906
Trial Duration For Participant
730

Eligibility

Recruits 906 paediatric patients.

Pregnancy Exclusion
Pregnancy
Vulnerable Population
Participants are children and adolescents (<18 years). The trial includes age-specific subject information sheets, assent forms and parent/guardian informed consent forms (multiple L1 SIS and ICF and Assent documents by age strata and country). Consent is required from parent/legal guardian for minors and age-appropriate assent is obtained from children/adolescents using the provided age-specific documents.

Inclusion criteria

  • {"criterion_text":"- Histological verification of diagnosis of LCH"}
  • {"criterion_text":"- Age < 18 years"}
  • {"criterion_text":"- No prior systemic therapy"}
  • {"criterion_text":"- Signed informded consent"}
  • {"criterion_text":"- Met inclusion criteria for respective stratum"}

Exclusion criteria

  • {"criterion_text":"- Pregnancy"}
  • {"criterion_text":"- Prior systemic therapy"}
  • {"criterion_text":"- Missing signed consent form"}
  • {"criterion_text":"- LCH related permanent consequences"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Reactivation-free survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Overall and disease free survival","definition_or_measurement_approach":""}
  • {"endpoint_text":"- To study the course of neurodegenerative CNS-LCH","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Response of isolated tumorous CNS lesions to 2-CdA","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Rate and spectrum of permanent consequences","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Incidence of permanent consequences","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Toxicity of treatment","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Proportion fo patients alive and free of disease without permanent consequences","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Cumulative incidence of reactivations in risk organs","definition_or_measurement_approach":""}

Recruitment

Registry Or Advocacy Recruitment
True, Spanish Paediatric Clinical Trials Network
Planned Sample Size
906
Recruitment Window Months
156
Consent Approach
Informed consent is required (signed informed consent). For minors, parent/legal guardian consent is required and age-appropriate assent and information sheets are provided. Multiple country- and age-specific Subject Information Sheets (SIS), Informed Consent Forms (ICF) and Assent documents are listed (e.g. Stratum-specific and age-group-specific ICF/SIS and Assent documents for many Member States). Documents exist in country-specific versions.

Geography

Total Number Of Sites
84
Total Number Of Participants
1124

Greece

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
30
Number Of Sites
6
Number Of Participants
13

Sites

Site Name
Athens General Children's Hospital Panagioti And Aglaia Kyriakou
Department Name
Oncology Department Aglaia Kyriakou (OTAK)
Contact Person Name
Marina Servitzoglou
Contact Person Email
mservitzoglou@gmail.com
Site Name
Ippokratio General Hospital Of Thessaloniki
Department Name
Pediatric-Oncology Department
Contact Person Name
Evgenia Papakonstantinou
Contact Person Email
dongol@ippokratio.gr
Site Name
University General Hospital Of Thessaloniki Ahepa
Department Name
Paediatric and Adolescent Hematology Oncology Unit of B' Paediatric Clinic of Aristotle University
Contact Person Name
Emmanouil Hatzipantelis
Contact Person Email
hatzip@auth.gr
Site Name
Nosokomeio Paidon I Agia Sofia
Department Name
Department of Pediatric Hematology and Oncology (TAO)
Contact Person Name
Vassilios Papadakis
Contact Person Email
vpapadak@otenet.gr
Site Name
University General Hospital Of Heraklion
Department Name
Hematology-Oncology Children’s Clinic
Contact Person Name
Iordanis Pelagiadis
Contact Person Email
ipelagiadis@icoud.com
Site Name
Mitera S.A.
Department Name
Children's - Adolescent's Oncology Clinic
Contact Person Name
Eleni Dana
Contact Person Email
ped.adol.onc@mitera.gr

Ireland

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
28
Number Of Sites
1
Number Of Participants
5

Sites

Site Name
Children's Health Ireland
Department Name
Pediatric Hematology/Oncology
Contact Person Name
Jane Pears
Contact Person Email
jane.pears@olhsc.ie

Italy

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
14-10-2024
Processing Time Days
33
Number Of Sites
25
Number Of Participants
422

Sites

Site Name
Azienda Ospedaliero Universitaria Pisana
Department Name
Pediatric Hematology and Oncology
Contact Person Name
Mariacristina Menconi
Contact Person Email
M.menconi@ao.pisa.toscana.it
Site Name
Istituto Nazionale Dei Tumori
Department Name
S.C. Oncologia Pediatrica
Contact Person Name
Stefano Chiaravelli
Site Name
Fondazione IRCCS San Gerardo Dei Tintori
Department Name
Clinica Pediatrica dell’Università Milano – Bicocca A.O. San Gerardo – Fondazione MBBM
Contact Person Name
Paola Corti
Site Name
Universita' Degli Studi Di Roma La Sapienza
Department Name
Oncoematologia pediatrica Ospedale “Bambino Gesù"
Contact Person Name
Franco Locatelli
Contact Person Email
franco.locatelli@opbg.net
Site Name
Alma Mater Studiorum Universita Di Bologna
Department Name
Oncologia Ematologia Pediatrica Ist. "Lalla Seràgnoli"
Contact Person Name
Fraia Melchionda
Contact Person Email
fraia.melchionda@aosp.bo.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
U.O Pediatria Ospedale Infermi
Contact Person Name
Roberta Pericoli
Contact Person Email
ropericoli@libero.it
Site Name
Second University Of Naples
Department Name
Servizio di Oncologia Pediatrica Dipartimento di Pediatria
Contact Person Name
Francesca Rossi
Contact Person Email
francesca.rossi@unicampania.it
Site Name
Azienda Ospedaliera Universitaria Meyer IRCCS
Department Name
Dipartimento A.I. Oncoematologia SODC Tumori ped.ci pianto di cellule staminali Azienda Osp
Contact Person Name
Elena Sieni
Contact Person Email
elena.sieni@meyer.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
UOC Oncoematologia Pediatrica
Contact Person Name
Simone Cesaro
Site Name
Azienda Sanitaria Locale Di Taranto
Department Name
U.O.C. di Pediatria ed Oncoematologia Pediatrica Ospedale Santissima Annunziata
Contact Person Name
Letizia Brescia
Site Name
Azienda Ospedaliero Universitaria Di Modena
Department Name
Dipartimento Materno-Infantile
Contact Person Name
Monica Cellini
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
UOC Oncoematologia Pediatrica Dipartimento Salute della Donna e del Bambino
Contact Person Name
Marco Zecca
Contact Person Email
m.zecca@smatteo.pv.it
Site Name
ARNAS Civico Di Cristina Benfratelli
Department Name
Oncoematologia Pediatrica ARNAS Civico Ospedale dei Bambini G. di Cristina
Contact Person Name
Antonino Trizzino
Contact Person Email
oncoematoped@arnascivico.it
Site Name
University Hospital Consorziale Policlinico
Department Name
Dipartimento Biomedicina Età Evolutiva
Contact Person Name
Nicola Santoro
Contact Person Email
nico.santoro1956@libero.it
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
Dipartimento di Ematologia Ospedale Civile Pescara
Contact Person Name
Nicole Santoro
Contact Person Email
aieop.pescara@gmail.com
Site Name
Azienda Socio Sanitaria Locale N. 8 Di Cagliari
Department Name
Oncoematologia Pediatrica e Patologia della Coagulazione
Contact Person Name
Rosa Maria Mura
Contact Person Email
rosamariamura@asl8cagliari.it
Site Name
IRCCS Istituto Giannina Gaslini
Department Name
Dipartimento di Scienze Pediatriche Generali e Specialistiche U.O.C. Oncologia
Contact Person Name
Massimo Conte
Contact Person Email
massimoconte@gaslini.org
Site Name
University Of Trieste
Department Name
U.O. Emato-Oncologia Pediatrica Università degli studi di Trieste
Contact Person Name
Marco Rabusin
Contact Person Email
marco.rabusin@burlo.trieste.it
Site Name
Universita' Degli Studi Di Perugia
Department Name
S.C. di Oncoematologia Pediatrica con Trapianto di CSE,
Contact Person Name
Maurizio Caniglia
Site Name
L’Azienda Ospedaliera Di Rilievo Nazionale Santobono-Pausilipon
Department Name
Dipartimento di Oncologia A.O. Santobono – Pausilipon
Contact Person Name
Carmen De Fusco
Contact Person Email
carmendefusco@iol.it
Site Name
Azienda Ospedaliera di Padova
Department Name
Dipartimento di Pediatria Università di Padova Cattedra Di Oncoematologia Pediatrica
Contact Person Name
Alessandra Todesco
Contact Person Email
alessandra.todesco@unipd.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department Name
Gobbi
Contact Person Name
Dr. Simona

Spain

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
14-10-2024
Processing Time Days
33
Number Of Sites
27
Number Of Participants
170

Sites

Site Name
Hospital Unviersitario Miguel Servet
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Carmen Rodriguez
Site Name
Hospital Universitario Donostia
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Nagore Garcia de Andoain
Site Name
Hospital Universitario Hm Monteprincipe
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Blanca Lopez-Ibor Alino
Contact Person Email
blopezibor@hmhospitales.com
Site Name
Hospital Universitario La Paz
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Antonio Perez
Site Name
University Hospital Of Canary Islands
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Macarena Gonzalez Cruz
Contact Person Email
macarenacruz@hotmail.com
Site Name
Sant Joan De Deu Barcelona Hospital
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Juan Pablo Munoz Perez
Contact Person Email
jmunoz@hsjdbcn.es
Site Name
Hospital De La Santa Creu I Sant Pau
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Montserrat Torrent
Contact Person Email
mtorrent@santpau.cat
Site Name
Spanish Paediatric Clinical Trials Network
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Manuel Fernandez San Marin
Site Name
Hospital General Universitario Dr. Balmis
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Cristina Moscardo
Contact Person Email
moscardo_cri@gva.es
Site Name
Hospital Universitario De Cruces
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Itziar Astigarraga
Site Name
Hospital General Universitario Gregorio Maranon
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Cristina Mata
Contact Person Email
cmata.ghugm@salud.madrid.org
Site Name
Hospital Universitario De Badajoz
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Maria Luisa Moreno Tejeiro
Contact Person Email
onc.infantil@salud-juntaex.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Aula de Hematología Servicio de Hematología
Contact Person Name
Guiomar Gutiérrez Schiaffino
Contact Person Email
guiogs@hotmail.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Ignacio Gutierrez Carrasco
Site Name
Hospital Universitario De Navarra
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Maria Sagaseta de Ilurdoz
Site Name
Hospital Universitario Central De Asturias
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Ana De Lucio Delgado
Contact Person Email
adelucio82@hotmail.com
Site Name
University Hospital Son Espases
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Jose Antonio Salinas Sanz
Contact Person Email
josea.salinas@ssib.es
Site Name
Hospital Infantil Universitario Nino Jesus
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
David Ruano
Contact Person Email
david.ruano@salud.madrid.org
Site Name
Hospital Universitario 12 De Octubre
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Vanesa Perez Alonso
Contact Person Email
vpereza@salud.madrid.org
Site Name
Hospital Alvaro Cunqueiro
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Maria Tallon Garcia
Contact Person Email
maria.tallon.garcia@sergas.es
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Oncohematologia infantil
Contact Person Name
Mar Bermudez
Contact Person Email
mariam.bermudez2@carm.es
Site Name
Hospital Universitario Reina Sofia
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Maria Elena Mateos
Site Name
Hospital Clinico Universitario De Valladolid
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Hermengildo Gonzalez
Contact Person Email
hermeneg@ped.uva.es
Site Name
Hospital General Universitario De Albacete
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Olga Garcia Mialdea
Contact Person Email
olgagarciami@gmail.com
Site Name
Hospital Universitario Virgen De Las Nieves
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Ma Jose Ortega
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Mara Andres Moreno
Contact Person Email
andres_mdm@gva.es
Site Name
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Department Name
Servicio de Oncología y Hematología Pediátricas
Contact Person Name
Lorena Valero
Contact Person Email
lorena.valero@vallhebron.cat

Sweden

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
30
Number Of Sites
6
Number Of Participants
62

Sites

Site Name
Karolinska University Hospital
Department Name
Pediatric oncology center, Astrid Lindgren Children's hospital, Eugeniavägen 23,17164 Stockholm
Contact Person Name
Jan-Inge Henter
Contact Person Email
jan-inge.henter@ki.se
Site Name
Region Oestergoetland
Department Name
Pediatric Oncology center, H.K.H. Kronprinsessan Victoria Children's hospital,Linköping University H
Contact Person Name
Lisa Törnudd
Site Name
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vastra Gotalandsregionen
Department Name
Pediatric oncology center, Behandlingsvägen 7
Contact Person Name
Cecilia Langenskiöld
Site Name
Region Skane Skanes Universitetssjukhus
Department Name
Pediatric Oncology center, Ward 64, Lasarettsgatan 48, Lund
Contact Person Name
Joakim Wille
Contact Person Email
joakim.wille@skane.se
Site Name
Uppsala University Hospital
Department Name
Pediatric Oncology and hematology center, Akademiska Sjukhuset, Uppsala
Contact Person Name
Per Frisk
Contact Person Email
per.frisk@kbh.uu.se
Site Name
Region Vaesterbotten
Department Name
Pediatric Oncology center, Norrlands university hospital, 90185 Umeå
Contact Person Name
Per-Erik Sandström
Contact Person Email
per-erik.sandstrom@umu.se

Netherlands

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
14-10-2024
Processing Time Days
33
Number Of Sites
1
Number Of Participants
113

Sites

Site Name
Prinses Maxima Centrum voor Kinderoncologie B.V.
Department Name
Hemato-Oncology
Contact Person Name
Cornelis van den Bos

Norway

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
12
Number Of Sites
4
Number Of Participants
35

Sites

Site Name
Helse Bergen HF
Department Name
Pediatric Hematology/Oncology
Contact Person Name
Anita Andrejeva
Site Name
St. Olavs Hospital HF
Department Name
Department Paediatric Haemato-oncology
Contact Person Name
Erling Moe
Contact Person Email
Erling.Moe@stolav.no
Site Name
Oslo University Hospital HF
Department Name
Dept. of Pediatric Medicine
Contact Person Name
Monica Munthe-Kaas
Contact Person Email
UXMOMU@ous-hf.no
Site Name
Universitetssykehuset Nord-Norge HF
Department Name
Pediatric Hematology/Oncology
Contact Person Name
Tove Anita Nystad
Contact Person Email
Tove.Anita.Nystad@unn.no

Poland

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
13-10-2024
Processing Time Days
32
Number Of Sites
1
Number Of Participants
47

Sites

Site Name
Instytut Matki I Dziecka
Department Name
Dept. of Oncology and Surgical Oncology f. children and Youth
Contact Person Name
Anna Raciborska
Contact Person Email
anna.raciborska@hoga.pl

Austria

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
14-10-2024
Processing Time Days
33
Number Of Sites
5
Number Of Participants
66

Sites

Site Name
Paracelsus Medizinische Privatuniversitaet Salzburg
Department Name
Department of Pediatric Hematology/Oncology
Contact Person Name
Neil Jones
Contact Person Email
n.jones@salk.at
Site Name
St. Anna Kinderspital GmbH
Department Name
Deptartment of Pediatric Hematology/Oncology
Contact Person Name
Wolfgang Holter
Contact Person Email
wolfgang.holter@stanna.at
Site Name
University Hospital Graz
Department Name
Department of Pediatric Hematology/Oncology
Contact Person Name
Markus Seidel
Contact Person Email
markus.seidel@medunigraz.at
Site Name
Tirol Kliniken GmbH
Department Name
Department of Pediatric Hematology/Oncology
Contact Person Name
Bernhard Meister
Contact Person Email
bernhard.meister@i-med.ac.at
Site Name
Kepler Universitaetsklinikum GmbH
Department Name
Department of Pediatric Hematology/Oncology
Contact Person Name
Georg Ebetsberger-Dachs

Belgium

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
09-10-2024
Processing Time Days
28
Number Of Sites
2
Number Of Participants
90

Sites

Site Name
UZ Leuven
Department Name
Department Paediatric Haemato-oncology
Contact Person Name
Sandra Jacobs
Contact Person Email
sandra2.jacobs@uzleuven.be
Site Name
Universitair Ziekenhuis Gent
Department Name
Department Paediatric Haemato-oncology
Contact Person Name
Victoria Bordon
Contact Person Email
victoria.bordon@uzgent.be

Czechia

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
11-10-2024
Processing Time Days
30
Number Of Sites
2
Number Of Participants
45

Sites

Site Name
Fakultni Nemocnice Brno
Department Name
Dept. of Pediatric Oncology
Contact Person Name
Zdenka Krenova
Contact Person Email
krenova.zdenka@fnbrno.cz
Site Name
Univerzita Karlova 2 Lekarska Fakulta
Department Name
Pediatric Hematology/Oncology
Contact Person Name
Karel Svojgr
Contact Person Email
karel.svojgr@fnmotol.cz

Denmark

Earliest CTIS Part Ii Submission Date
11-09-2024
Latest Decision Or Authorization Date
14-04-2026
Processing Time Days
580
Number Of Sites
4
Number Of Participants
56

Sites

Site Name
Odense University Hospital
Department Name
Hans Christian Andersen Children´s Hospital
Contact Person Name
Mathias Rathe
Contact Person Email
mathias.rathe@rsyd.dk
Site Name
Rigshospitalet
Department Name
Dept. of Pediatrics and Adolescent Medicine
Contact Person Name
Karsten Nysom
Contact Person Email
karsten.nysom@regionh.dk
Site Name
Aarhus Universitetshospital
Department Name
Dept. of Pediatric and Adolescent Medicine
Contact Person Name
Torben Stamm Mikkelsen
Contact Person Email
torbmikk@rm.dk
Site Name
Aalborg University Hospital
Department Name
Dept. of Paediatric Haematology & Oncology
Contact Person Name
Ines Ackerl Kristensen
Contact Person Email
iak@rn.dk

Sponsor

Primary sponsor

Full Name
St. Anna Childrens Cancer Research Institute GmbH
Organisation Type
Pharmaceutical company
Country Of Registered Address
Austria

Contract research organisations

Name
Coronis Research S.A.
Responsibilities
sponsorDuties code 5; contact email LCHIV@coronis.gr; phone +302108778124

Third parties

  • {"country":"Greece","full_name":"Coronis Research S.A.","duties_or_roles":"sponsorDuties code 5; contact email LCHIV@coronis.gr","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1; contact email gcp-enheden.bispebjerg-frederiksberg-hospitaler@regionh.dk","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
OCTAGAM 10 %, Lösung zur intravenösen Infusion
Active Substance
Human normal immunoglobulin (IV)
Modality
Peptide/protein/enzyme
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
PEI.H.03627.01.1
Maximum Dose
500 mg/kg
Investigational Product Name
Cytarabine 20 mg/ml Solution for Injection/Infusion
Active Substance
Cytarabine
Modality
Small molecule
Routes Of Administration
INTRAVENOUS ADMINISTRATION
Route
INTRAVENOUS
Authorisation Status
PA2315/082/002
Maximum Dose
100 mg/m2
Investigational Product Name
Fludarabine phosphate 25 mg/ml Concentrate for Solution for Injection or Infusion
Active Substance
Fludarabine phosphate
Modality
Small molecule
Routes Of Administration
IV INFUSION
Route
IV INFUSION
Authorisation Status
PA 2315/035/001
Maximum Dose
30 mg/m2
Investigational Product Name
Prednisolone 5mg Tablets
Active Substance
Prednisolone
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
PL 29831/0178
Maximum Dose
40 mg/m2
Investigational Product Name
Methotrexate 10 mg Tablets
Active Substance
Methotrexate
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
PA2315/062/002
Maximum Dose
20 mg/m2
Investigational Product Name
Vinblastine Sulfate 1 mg/ml Solution for Injection or Infusion
Active Substance
Vinblastine sulfate
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS USE
Route
INTRAVENOUS BOLUS
Authorisation Status
PA 0822/208/001
Maximum Dose
6 mg/m2
Investigational Product Name
Melphalan 50 mg Powder and Solvent for Solution for Injection/Infusion
Active Substance
Melphalan
Modality
Small molecule
Routes Of Administration
INTRAVENOUS INFUSION
Route
INTRAVENOUS INFUSION
Authorisation Status
PL 39699/ 0039
Maximum Dose
140 mg/m2
Investigational Product Name
INDOMETACIN CAPSULES BP 25mg
Active Substance
Indometacin Ph. Eur.
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
PRD4925112
Maximum Dose
2 mg/kg
Investigational Product Name
LEMTRADA 12 mg concentrate for solution for infusion
Active Substance
Alemtuzumab
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
EU/1/13/869/001
Maximum Dose
0.2 mg/kg
Investigational Product Name
Mercaptopurine Silver Pharma 50 mg tablets
Active Substance
Mercaptopurine monohydrate
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
PA23137/001/001
Maximum Dose
50 mg/m2
Investigational Product Name
LITAK 2 mg/ml solution for injection
Active Substance
Cladribine
Modality
Small molecule
Routes Of Administration
INTRAVENIOUS INFUSION
Route
INTRAVENIOUS INFUSION
Authorisation Status
EU/1/04/275/002
Maximum Dose
9 mg/m2
Combination Treatment
Yes

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