Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruiting
Participants planned
1,558
Countries
12
Sites
61
Acute Lymphoblastic Leukaemia
Stratum 1 – randomised question (closed in December 2018, randomised patients in active follow-up): To show that a non-total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years af…
Key facts
- Sponsor
- St. Anna Childrens Cancer Research Institute GmbH
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 27 Mar 2014 → ongoing
- Decision date (initial)
- 2024-10-14
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- St. Anna Kinderkrebsforschung GmbH/Children’s Cancer Research Institute (CCRI)
External identifiers
- EU CT number
- 2024-512657-24-00
- EudraCT number
- 2012-003032-22
- ClinicalTrials.gov
- NCT01949129
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety, Pharmacogenomic, Pharmacokinetic
Stratum 1 – randomised question (closed in December 2018, randomised patients in active follow-up): To show that a non-total body irradiation (TBI) containing conditioning (Flu/Thio/ivBu or Flu/Thio/Treo) results in a non-inferior survival as compared to conditioning with TBI/Etoposide in children older than 4 years after HSCT from a Human leucocyte antigen (HLA) identical sibling donor (MSD) or an HLA matched donor (MD).
Stratum 1 – MSD/MD: To explore the impact of risk factors on the incidence of adverse events of special interest (AESIs) and on overall survival and event free survival in the entire cohort (question 3 and 5).
Stratum 1 – MSD/MD in age-group 2-4 years: To explore incidence of adverse events of special interest (AESIs) and short-term overall survival and event free survival in the entire cohort receiving TBI/VP16 conditioning regimen.
Stratum 2 – MMD: To explore event free survival (EFS) after HSCT from HLA mismatched donors using mismatched unrelated donors (MMD), mismatched cord blood or HLA haplo-identical family members.
Conditions and MedDRA coding
Acute Lymphoblastic Leukaemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | SOC | 10029104 | Neoplasms benign malignant and unspecified (incl cysts and polyps) | 2 |
Regulatory references
- Scientific advice from competent authorities
- Bundesministerium Fuer Soziales Gesundheit Pflege Und Konsumentenschutz
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- All patients with ALL (except for patients with mature B-ALL) who fulfil the following criteria:
- Age at diagnosis ≤ 18 years OR age at HSCT ≤ 21 years
- Indication for allogeneic HSCT
- Complete remission (CR) before SCT
- Written consent of the parents (legal guardian) and, if necessary, the minor patient via “Informed Consent Form”
- No pregnancy
- No secondary malignancy
- No previous HSCT
- HSCT is performed in a study participating centre
Exclusion criteria 7
- Patients who do not fulfil the inclusion criteria
- Non-Hodgkin Lymphoma
- Whole protocol and/or its essential parts are refused either by the patient himself/herself or the respective legal guardian
- No consent is given for saving and propagation of anonymous medical data for study reasons
- Severe concomitant disease that does not allow treatment according to the protocol at the investigator’s discretion e.g.: malformation syndromes, cardiac malformations, metabolic disorders; renal impairment (< 30% of normal glomerular filtration rate); severe pulmonary, hepatic or cardiac impairment due to toxicity or infection
- Karnofsky / Lansky score < 50%
- Subjects unwilling or unable to comply with the study procedures
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Stratum 1: Overall Survival (OS)
- Stratum 2: Event Free Survival (EFS)
Secondary endpoints 7
- Stratum 1: EFS
- Stratum 2: OS
- Stratum 1 and 2: Cumulative Incidence of Treatment-related mortality (TRM)
- Stratum 1 and 2: Cumulative Incidence of Relapse
- Stratum 1 and 2: Toxicity: acute and late
- Stratum 1 and 2: Acute Graft versus Host Disease (aGVHD) and chronic GVHD (cGvHD)
- Stratum 1 and 2: Secondary malignancies
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 8
Anti-Human T-Lymphocyte Immunoglobulin From Rabbits
SUB21246 · Substance
- Active substance
- Anti-Human T-Lymphocyte Immunoglobulin From Rabbits
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 15 mg/kg milligram(s)/kilogram
- Max total dose
- 45 mg/kg milligram(s)/kilogram
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13897MIG · Substance
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 150 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10985MIG · Substance
- Active substance
- Thiotepa
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 mg/kg milligram(s)/kilogram
- Max total dose
- 10 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 120 mg/kg milligram(s)/kilogram
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rabbit Anti-Human Thymocyte Immunoglobulin
SUB30326 · Substance
- Active substance
- Rabbit Anti-Human Thymocyte Immunoglobulin
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2.5 mg/kg milligram(s)/kilogram
- Max total dose
- 7.5 mg/kg milligram(s)/kilogram
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion.
PRD3418637 · Product
- Active substance
- Blinatumomab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 28 µg/ m2 microgram(s)/ sq. Meter
- Max total dose
- 784 µg/ m2 microgram(s)/ sq. Meter
- Max treatment duration
- 28 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX07 — -
- Marketing authorisation
- EU/1/15/1047/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/650
- Modified vs. Marketing Authorisation
- No
SUB11235MIG · Substance
- Active substance
- Treosulfan
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 14000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 42000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05993MIG · Substance
- Active substance
- Busulfan
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4.8 mg/kg milligram(s)/kilogram
- Max total dose
- 19.2 mg/kg milligram(s)/kilogram
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 60 mg/kg milligram(s)/kilogram
- Max total dose
- 60 mg/kg milligram(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
St. Anna Childrens Cancer Research Institute GmbH
- Sponsor organisation
- St. Anna Childrens Cancer Research Institute GmbH
- Address
- Zimmermannplatz 10, Alsergrund Alsergrund
- City
- Vienna
- Postcode
- 1090
- Country
- Austria
Scientific contact point
- Organisation
- St. Anna Childrens Cancer Research Institute GmbH
- Contact name
- Christina Peters
Public contact point
- Organisation
- St. Anna Childrens Cancer Research Institute GmbH
- Contact name
- Christina Peters
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Frederiksberg Hospital ORG-100028217
|
Frederiksberg, Denmark | On site monitoring |
Locations
12 EU/EEA countries · 61 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Authorised, recruitment pending | 81 | 3 |
| Belgium | Authorised, recruitment pending | 26 | 5 |
| Czechia | Ongoing, recruiting | 56 | 1 |
| Denmark | Authorised, recruitment pending | 47 | 1 |
| France | Ongoing, recruitment ended | 203 | 13 |
| Germany | Ongoing, recruitment ended | 373 | 24 |
| Italy | Authorised, recruitment pending | 134 | 3 |
| Netherlands | Authorised, recruitment pending | 35 | 1 |
| Norway | Authorised, recruitment pending | 39 | 1 |
| Slovakia | Authorised, recruitment pending | 37 | 1 |
| Spain | Authorised, recruitment pending | 43 | 4 |
| Sweden | Authorised, recruitment pending | 34 | 4 |
| Rest of world
Turkey, Argentina, Switzerland, Belarus, Mexico, Israel, Saudi Arabia, Canada, New Zealand, Chile, Malaysia, Australia
|
— | 450 | — |
Investigational sites
Medizinische Universitaet Innsbruck
Pädiatrische Hämatologie, Onkologie und Stammzelltransplantation, Anichstrasse 35, 6020, Innsbruck
Medical University Of Graz
Pädiatrische Hämato-Onkologie, Neue Stiftingtalstrasse 6, 8010, Graz
St. Anna Kinderspital GmbH
Hämatologische, Onkologische und Immunologische Abteilung, Stammzelltransplantationseinheit, Kinderspitalgasse 6, Alsergrund, Vienna
Association Hospitaliere De Bruxelles Hopital Universitaire Des Enfants Reine Fabiola
Paediatric haemato-oncology, Jean Joseph Crocqlaan 15, 1020, Brussels
Universitair Ziekenhuis Gent
Paediatric haemato-oncology, Corneel Heymanslaan 10, 9000, Gent
UZ Leuven
Paediatric haemato-oncology, Herestraat 49, 3000, Leuven
Cliniques Universitaires Saint-Luc
Paediatric haemato-oncology, Hippokrateslaan 10, Batiment 54, Sint-Lambrechts-Woluwe
Centre Hospitalier Universitaire De Liege
Paediatric haemato-oncology, Avenue De L'hopital 1, 4000, Liege
Rigshospitalet
Department of Paediatrics and Adolescent Medicine, Blegdamsvej 9, 2100, Copenhagen Oe
Hospices Civils De Lyon
Institut d'hématologie et d'oncologie pédiatrique, 1 Place Professeur Joseph Renaut, 69008, Lyon
University Hospital Of Clermont-Ferrand
Centre régional de cancérologie et de thérapie cellulaire pédiatrique, 1 Place Lucie Et Raymond Aubrac, 63100, Clermont-Ferrand
Centre Hospitalier Regional De Marseille
Hématologie et oncologie pédiatrique, 264 Rue Saint Pierre, 13005, Marseille
Les Hopitaux Universitaires De Strasbourg
Service d'hématologie et d'oncologie pédiatrique, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire Rouen
Service d'hémato-Immuno-Oncologie pédiatrique, 1 Rue De Germont, Bp 96031, Rouen Cedex
Centre Hospitalier Universitaire De Nantes
Service d'onco hématologie pédiatrie, 7 Quai Moncousu, 44000, Nantes
Robert Debre University Hospital
Hémato-immunologie pédiatrique, 48 Boulevard Serurier, 75019, Paris
Centre Hospitalier Universitaire Grenoble Alpes
Service de Pédiatrie - Immuno-hémato-oncologie pédiatrique, Quai Yermoloff, 38700, La Tronche
CHRU De Nancy
Service d'oncologie pédiatrique, 6eme Etage, 11 Rue Du Morvan, Vandoeuvre Les Nancy Cedex
Centre Hospitalier Universitaire De Montpellier
Onco-hématologie pédiatrique, 371 Avenue Du Doyen Gaston Giraud, 34091, Montpellier Cedex 5
Centre Hospitalier Universitaire De Lille
Hématologie pédiatrique - Unité Greffe, Avenue Eugene Avinee, 59037, Lille Cedex
Centre Hospitalier Universitaire De Rennes
Service de médecine de l'enfant et de l'adolescent - Unité d'hémato-oncologie, 16 Boulevard De Bulgarie, Bp 90349, Rennes
Centre Hospitalier Universitaire De Bordeaux
Oncologie-Hématologie, Place Amelie Raba Leon, 33000, Bordeaux
Universitaetsklinikum Jena KöR
Klinik für Kinder- und Jugendmedizin, Sektion Hämatologie / Onkologie / SZT, Am Klinikum 1, Lobeda, Jena
Universitaetsklinikum Regensburg AöR
Pädiatrische Onkologie, Hämatologie und Stammzelltransplantation, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Tuebingen AöR
Klinik für Kinder u. Jugendmedizin Abt. 1, Hämat., Onkologie, Gastroent., Nephrol., Rheumatologie, Hoppe-Seyler-Strasse 1, Nordstadt, Tuebingen
Universitaet Leipzig
UKL, Department für Frauen- u. Kindermedizin, Abt. f. Pädiatrische Onkologie, Hämatologie u. Hämost., Liebigstrasse 22, Zentrum-Suedost, Leipzig
Charite Universitaetsmedizin Berlin KöR
Klinik für Pädiatrie m. S. Hämatologie und Onkologie, Augustenburger Platz 1, Wedding, Berlin
Universitaetsklinikum Essen AöR
Klinik f. Kinder- u. Jugendmedizin, Kinderheilkunde III, Päd. Häm-Onkologie, Pneum. Kardiol. Rheum., Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsmedizin Greifswald KöR
Klinik für Kinder- und Jugendmedizin, Abteilung für päd. Hämatolgie und Onkologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Universitaet Muenster
Klinik für Kinder- und Jugendmedizin, pädiatrische Hämatologie und Onkologie, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Giessen und Marburg GmbH
Pädiatrische Hämatologie, Onkologie & Immundefekte, Feulgenstrasse 10-12, 35392, Giessen
Universitaetsklinikum Duesseldorf AöR
Klinik für Kinder-Onkologie, -Hämatologie und Klin. Immunologie, Bereich Päd. Stammzelltherapie, Moorenstrasse 5, Bilk, Duesseldorf
Klinikum rechts der Isar der TU Muenchen AöR
Klinik für Kinder- und Jugendmedizin, Koelner Platz 1, Schwabing-West, Munich
Goethe University Frankfurt
Klinik für Kinder- und Jugendmedizin, Schwerpunkt Stammzelltransplantation und Immunologie, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Universitaetsklinikum Aachen AöR
Klinik für Kinder-u. Jugendmedizin Pädiatrische Hämatologie, Onkologie u. SZT, Pauwelsstrasse 30, 52074, Aachen
Universitaetsklinikum Heidelberg AöR
Klinik für Kinder- und Jugendmedizin, Abteilung III, Onkologie, Hämatologie und Immunologie, Im Neuenheimer Feld 430, Neuenheim, Heidelberg
Medizinische Hochschule Hannover
Pädiatrische Hämatologie und Onkologie Medizinische Hochschule Hannover, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Bonn AöR
Zentrum für Kinder- und Jugendmedizin, Abteilung Päd. Hämatologie / Onkologie, Venusberg-Campus 1, Venusberg, Bonn
University Medical Center Hamburg-Eppendorf
Zentrum f. Geburtshilfe, Kinder- u. Jugendmedizin, Sektion f. Päd. Stammzelltransplant. u. Immunol., Martinistrasse 52, Eppendorf, Hamburg
Medical Center - University Of Freiburg
Klinik für Pädiatrische Hämatologie und Onkologie, Mathildenstrasse 1, Stuehlinger, Freiburg Im Breisgau
Universitaetsklinikum Wuerzburg AöR
Pädiatrische Onkologie, Hämatologie, Stammzelltransplantation, Josef-Schneider-Strasse 2, Grombuehl, Wuerzburg
Martin-Luther-Universitaet Halle-Wittenberg
Klinik und Poliklinik für Pädiatrie I, Ernst-Grube-Strasse 40, Kroellwitz, Halle (Saale)
Universitaetsklinikum Ulm AöR
Klinik für Kinder- u. Jugendmedizin, Pädiatrische Immunologie, Rheumatologie u. Stammzelltransplan, Eythstrasse 24, Mitte, Ulm
Universitaetsklinikum Erlangen AöR
Kinder- und Jugendklinik, Pädiatrische Hämatologie und Onkologie, Loschgestrasse 15, Innenstadt, Erlangen
Klinikum der Universitaet Muenchen AöR
Dr. von Haunersches Kinderspital, Abteilung Hämatologie, Onkologie und Stammzelltransplantation, Lindwurmstrasse 4, Ludwigsvorstadt-Isarvorstadt, Munich
Universitaetsklinikum Schleswig-Holstein AöR
Klinik für Kinderonkologie und -rheumatologie, Arnold-Heller-Strasse 3, Brunswik, Kiel
Fondazione IRCCS Policlinico San Matteo
Pediatric Hematology and Oncology, Viale Camillo Golgi 19, 27100, Pavia
Ospedale Pediatrico Bambino Gesu
OncoEmatology, Cellular Therapy Gene Therapy and Hemopoietic Transplantation, Piazza Di Sant'onofrio 4, 00165, Rome
Fondazione IRCCS San Gerardo Dei Tintori
Clinica Pediatrica, Fondazione IRCCS San Gerardo dei Tintori Monza, Via Giovanni Battista Pergolesi 33, 20900, Monza
Prinses Maxima Centrum voor Kinderoncologie B.V.
Stem cell Transplantation and cellular therapy, Heidelberglaan 25, 3584 CS, Utrecht
Oslo University Hospital HF
Pediatric Hematology and Oncology, Taarnbygget, Kirkeveien 166, Oslo
Narodny Ustav Detskych Chorob
Department of Pediatric Hematology and Oncology, Limbova 1, 833 40, Bratislava
Hospital De La Santa Creu I Sant Pau
Unidad de Hematología, Oncología y Trasplante Hematopoyético Servicio de Pediatría, Carrer De San Quinti 89, 08041, Barcelona
Hospital Universitario Central De Asturias
Servicio de Oncología y Hematología Pediátricas, Avenida De Roma S/n, 33011, Oviedo
Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca
Jefe de Sección Servicio de Oncología y Hem. Ped. Vall d’Hebron Barcelona Hosp. Campus, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Clinical Hospital Virgen De La Arrixaca
Hospital de día de oncohematología infantil Segunda planta del hospital infantil, Carretera Madrid-Cartagena S/N, El Palmar, Murcia
Uppsala University Hospital
Pediatric Oncology, Akademiska Sjukhuset, 751 85, Uppsala
Karolinska University Hospital
Department of pediatrcis, Halsovagen, Flemingsberg, Huddinge
Region Skane Skanes Universitetssjukhus
Department of pediatric medicine, Entregatan 7, 222 42, Lund
Queen Silvia Childrens Hospital - Sahlgrenska University Hospital - Vaestra Goetalandsregionen
Children's Cancer Center, Behandlingsvagen 7, Harlanda, Gothenburg
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2014-09-26 | 2014-09-26 | |||
| France | 2015-03-20 | 2015-03-20 | 2021-08-25 | ||
| Germany | 2014-03-27 | 2014-03-27 | 2022-03-31 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 137 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-512657-24-00_redacted | 8.0 |
| Protocol (for publication) | D1_Protocol Appendix1a_2024-512657-24-00_redacted | 8.0 |
| Protocol (for publication) | D1_Protocol Appendix1b_2024-512657-24-00_redacted | 6.0 |
| Protocol (for publication) | D1_Protocol Appendix2_2024-512657-24-00_redacted | 8.0 |
| Protocol (for publication) | D1_Protocol Appendix3_2024-512657-24-00_redacted | 8.0 |
| Protocol (for publication) | D1_Protocol Appendix4_2024-512657-24-00_redacted | 8.0 |
| Protocol (for publication) | D1_Protocol Appendix5_2024-512657-24-00_redacted | 8.0 |
| Protocol (for publication) | D1_Protocol Appendix6_2024-512657-24-00_redacted | 8.0 |
| Protocol (for publication) | D1_Protocol Appendix7_2024-512657-24-00_redacted | 8.0 |
| Recruitment arrangements (for publication) | K1_FORUM_Recruitment Arrangements_NL | n.a. |
| Recruitment arrangements (for publication) | K1_GER_Recruitment_arrangements | n.a. |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Prague | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K1_Recruitment_arrangements_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Recruitment arrangements (for publication) | K2_Recruitment_material_Placeholder | n.a. |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ FR_ addendum-major_Data_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ FR_ Ancilary-parents_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ FR_13-18_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ FR_7-12_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ FR_addendum-parents_Data_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ FR_Parents_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ FR_Parents-less4years_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ SK_FORUM Info 18r_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ SK_FORUM main Info rodicov_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ SK_FORUM main InfSuhlas_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ SK_FORUM main InfSuhlas18r_redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ SK_InfoSuhlasPacientovDosiahli18rPocasStudie_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF ENG 12_18years_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF ENG 8_12years_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF ENG over18_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF ENG Parents_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF FR 12_18ans_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF FR 8_12ans_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF FR Parents_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF FR plus18_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF NL 12_18years_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF NL 8_12years_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF NL ouders_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_BE_ALLSCTNOR ICF NL over18_redacted | 3 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_FR_Adult_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_FR_Ancillary-13-18_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_FR_Ancillary-7-12_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_SE_Foraldrar INFO_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_SE_PAT INFO 10-15_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_SE_PAT INFO 15-18_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_SE_PAT INFO 18-21_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_SE_PAT INFO UNDER 10 AR_Redacted | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_AT_FORUM_10-14J_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_AT_FORUM_14-18J_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_AT_FORUM_volljahrig gewordene_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_12-14 yr_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_15-17 yr_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_6-12 yr_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_CZ_Parents and Adults 18plus_redacted | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_ALL SCTped 2012 FORUM_Patinfo-IC Erwachs ueber 18 J_redacted | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_ALL SCTped 2012 FORUM_Patinfo-IC_Elterninfo_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_ALL SCTped 2012 FORUM_Patinfo-IC_Kinder 10-13 J_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_ALL SCTped 2012 FORUM_Patinfo-IC_Kinder 14-17 J_redacted | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DE_ALL SCTped 2012 FORUM_Patinfo-IC_Kinder unter 10 J_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_FORUM - Forldre Samtykkeerklring S6_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_FORUM - Forldre-standard_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_FORUM - Forldre-under 2 ar_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_FORUM - Unge-standard_redacted | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_FORUM - Voksne 18plus-med biologisk materiale_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_FORUM - Voksne 18plus-med biologisk materiale-Samtykkeerklring S3_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_FORUM - Voksne 18plus-uden biologisk materiale_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_DK_FORUM - Voksne 18plus-uden biologisk materiale-Samtykkeerklring S1_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ES_ HIP-CI mayores 18 anos_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ES_12 -17 anos_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ES_18 anos_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ES_Hoja informativa para paciente hasta 11 anos_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ES_Padres_tutores-menores 12 anos_redacted | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FORUM_Eltern_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FORUM_uber 18J_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FORUM_unter 10J_redacted | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_AIF Bambini_FORUM Blina post TX_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_AIF_ Adolescenti_FORUM Blina post TX_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_IAF_Adolescenti_ALL SCTped 2012 Forum_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_IAF_Bambini_ALL SCTped 2012 Forum_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_ICF_Genitori del minore_FORUM Blina post TX_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_ICF_Genitori minore_ALL SCTped 2012 Forum_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_ICF_Maggiorenni_ALL SCTped 2012 Forum_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_ICF_Maggiorenni_FORUM Blina post TX_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_ICF_Privacy Ricerca Adulti_ALL SCTped 2012 Forum_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_ICF_Privacy Ricerca genitori minori_ALL SCTped 2012 Forum_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_ICF_Privacy Ricerca genitori minori_FORUM Blina post TX_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_IT_ICF_Privacy Ricerca pazienti adulti_FORUM Blina post TX_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_E1E2-FORUM_PIF-IC_12-15jr_PMC_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_E1E2-FORUM_PIF-IC_16jr eo_PMC_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL_E1E2-FORUM_PIF-IC_ouders_PMC_redacted | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MMD - foreldre versjon_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MMD - pas over 18 ar_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MMD - ungdommer 12-15 ar_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MMD - ungdommer 16-18 ar_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MSD MFD og MUD over 2 ar - foreldre versjon_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MSD MFD og MUD over 2 ar - pas over 18 ar_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MSD MFD og MUD over 2 ar - ungdommer 12-15 ar_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MSD MFD og MUD over 2 ar - ungdommer 16-18 ar_redacted | n.a. |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NO_MSD MFD og MUD under 2 ar - foreldre versjon_redacted | n.a. |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Contacts points and patient advocate_redacted | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AntiHumanLyImmunoglRabbit | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_AntiHumanLyImmunoglRabbit_EN | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Blincyto | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Blincyto_EN | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Busulfan | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Busulfan_EN | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cyclophosphamid | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cyclophosphamide_EN | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Etoposid | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Etoposide_EN | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fludarabin | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fludarabin_EN | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_RabbitAntihumanThymoImmunogl | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_RabbitAntihumanThymoImmunogl_EN | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Thiotepa | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Thiotepa_EN | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Treosulfan | n.a. |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Treosulfan_EN | n.a. |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis en-AT 2024-512657-24-00_redacted | 8.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Austria | Acceptable 2024-10-09
|
2024-10-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-14 | Acceptable | 2025-09-18 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-08-21 | Acceptable | 2025-09-05 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-22 | Acceptable | 2025-10-13 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-10-30 | Acceptable | 2025-11-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-02-27 | Acceptable | 2026-03-19 | |
| 7 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-03-11 | Acceptable | 2026-04-17 |