Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruiting
Participants planned
1,410
Countries
17
Sites
117
Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.
1) Assess the risk of delayed adverse events (AEs) following exposure to GM T cells; 2) Monitor for long-term persistence of GM T cell drug products; 3) Monitor for generation of replication competent lentiviruses (RCL), for lentiviral vector-derived GM T-cell drug products; 4) Assess long-term efficacy following tr…
Key facts
- Sponsor
- Celgene Corp.
- Participant type
- Pediatric, Patients
- Age range
- 0-17 years, 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Immune System Diseases [C20], Diseases [C] - Neoplasms [C04]
- Trial duration
- 21 Dec 2018 → ongoing
- Decision date (initial)
- 2023-09-11
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-504201-36-00
- EudraCT number
- 2017-001465-24
- WHO UTN
- U1111-1206-8250
- ClinicalTrials.gov
- NCT03435796
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
1) Assess the risk of delayed adverse events (AEs) following exposure to GM T cells;
2) Monitor for long-term persistence of GM T cell drug products;
3) Monitor for generation of replication competent lentiviruses (RCL), for lentiviral vector-derived GM T-cell drug products;
4) Assess long-term efficacy following treatment with GM T cells;
5)Describe growth and sexual maturity status for subjects who were aged < 18 years at time of GM T-cell treatment
Secondary objectives 1
- To monitor for B-cell levels in participants who received liso-cel.
Conditions and MedDRA coding
Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10025631 | Malignant lymphoid neoplasm NOS | 10029104 |
Regulatory references
- Plan to share IPD
- Yes
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-506003-26-00 | A Phase 1, Open-Label, Dose-Finding Study of BMS-986453, BCMAxGPRC5D Bi-specific Chimeric Antigen Receptor (CAR) T Cells, in Subjects with Relapsed and or Refractory Multiple Myeloma. | Celgene Corp. |
| 2019-004081-18 | A PHASE 2, OPEN-LABEL, SINGLE-ARM, MULTICOHORT, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF JCAR017 IN ADULT SUBJECTS WITH RELAPSED OR REFRACTORY INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL) (Transcend FL), Estudio en fase II, sin enmascaramiento, multicéntrico, de cohortes múltiples y de un solo grupo para evaluar la eficacia y la seguridad del JCAR017 en sujetos adultos con linfoma no hodgkiniano (LNH) de linfocitos B de escasa malignidad recidivante o resistente al tratamiento, ÉTUDE DE PHASE II OUVERTE, A BRAS UNIQUE, AVEC PLUSIEURS COHORTES, MULTICENTRIQUE VISANT A DETERMINER L’EFFICACITE ET LA SECURITE DU JCAR017, CHEZ DES PATIENTS ADULTES ATTEINTS DE LYMPHOME NON HODGKINIEN (LNH) A CELLULES B INDOLENT RECIDIVANT OU REFRACTAIRE (Transcend FL), Studio di fase 2, in aperto, a braccio singolo, a coorti multiple, multicentrico per valutare l’efficacia e la sicurezza di JCAR017 in soggetti adulti con linfoma non – Hodgkin a cellule B indolente recidivante o refrattario (NHL) (TRANSCEND FL) | |
| 2017-002245-29 | A phase 2, multicenter study to determine the efficacy and safety of bb2121 in subjects with relapsed and refractory multiple myeloma, ESTUDIO MULTICÉNTRICO, FASE II PARA DETERMINAR LA EFICACIA Y LA SEGURIDAD DE BB2121 EN PACIENTES CON MIELOMA MÚLTIPLE EN RECAIDA Y REFRACTARIO, Studio di fase 2, multicentrico, per determinare l¿efficacia e la sicurezza di bb2121 in soggetti con mieloma multiplo recidivato e refrattario | |
| 2017-000106-38 | A Phase 2, Single-arm, Multi-cohort, Multi-center Trial to Determine the Efficacy and Safety of JCAR017 in Adult Subjects with Aggressive B-Cell Non-Hodgkin Lymphoma (TRANSCEND WORLD), Vaiheen 2, yhden hoitoryhmän, monikohortti-, monikeskustutkimus JCAR017:n tehokkuuden ja turvallisuuden määrittämiseksi aikuisilla potilailla, joilla on aggressiivinen B-solu ei-Hodgkin-lymfooma, Vaiheen 2, yhden hoitoryhmän, monikohortti-, monikeskustutkimus JCAR017:n tehokkuuden ja turvallisuuden määrittämiseksi aikuisilla potilailla, joilla on aggressiivinen B-solu ei-Hodgkin-lymfooma, Vaiheen 2, yhden hoitoryhmän, monikohortti-, monikeskustutkimus JCAR017:n tehokkuuden ja turvallisuuden määrittämiseksi aikuisilla potilailla, joilla on aggressiivinen B-solu ei-Hodgkin-lymfooma, Ensayo de fase II, multicéntrico, de cohortes múltiples y de un solo brazo para evaluar la eficacia y seguridad de JCAR017 en sujetos adultos con linfoma no Hodgkin de células B agresivo, Eine einarmige, multizentrische Multi-Kohorten-Studie der Phase 2 zur Bestimmung der Wirksamkeit und Sicherheit von JCAR017 bei erwachsenen Teilnehmern mit aggressivem B-Zell-Non-Hodgkin-Lymphom (B-NHL), Eine einarmige, multizentrische Multi-Kohorten-Studie der Phase 2 zur Bestimmung der Wirksamkeit und Sicherheit von JCAR017 bei erwachsenen Teilnehmern mit aggressivem B-Zell-Non-Hodgkin-Lymphom (B-NHL), Eine einarmige, multizentrische Multi-Kohorten-Studie der Phase 2 zur Bestimmung der Wirksamkeit und Sicherheit von JCAR017 bei erwachsenen Teilnehmern mit aggressivem B-Zell-Non-Hodgkin-Lymphom (B-NHL), Eine einarmige, multizentrische Multi-Kohorten-Studie der Phase 2 zur Bestimmung der Wirksamkeit und Sicherheit von JCAR017 bei erwachsenen Teilnehmern mit aggressivem B-Zell-Non-Hodgkin-Lymphom (B-NHL), Eine einarmige, multizentrische Multi-Kohorten-Studie der Phase 2 zur Bestimmung der Wirksamkeit und Sicherheit von JCAR017 bei erwachsenen Teilnehmern mit aggressivem B-Zell-Non-Hodgkin-Lymphom (B-NHL), Eine einarmige, multizentrische Multi-Kohorten-Studie der Phase 2 zur Bestimmung der Wirksamkeit und Sicherheit von JCAR017 bei erwachsenen Teilnehmern mit aggressivem B-Zell-Non-Hodgkin-Lymphom (B-NHL), Studio di fase 2, multicentrico, a singolo braccio e coorti multiple, per determinare l¿efficacia e la sicurezza di JCAR017 in soggetti adulti con Linfoma Non-Hodgkin a cellule B aggressivo | |
| 2018-000929-32 | A global randomized multicenter Phase 3 trial to compare the efficacy and safety of JCAR017 to standard of care in adult subjects with high-risk, transplant-eligible relapsed or refractory aggressive B-cell non-Hodgkin lymphomas (TRANSFORM), Estudio internacional de fase III, multicéntrico, y aleatorizado, para comparar la eficacia y seguridad de JCAR017 frente al tratamiento de referencia de pacientes adultos de alto riesgo, con linfoma no Hodgkin de células B agresivo en recaída o refractario y elegibles a trasplante (TRANSFORM)., Studio di fase 3, globale, randomizzato, multicentrico per confrontare l’efficacia e la sicurezza di JCAR017 con la terapia standard in soggetti adulti elegibili al trapianto affetti da linfomi non Hodgkin a cellule B aggressivi, ad alto rischio, recidivati o refrattari (TRANSFORM) | |
| 2018-000264-28 | A Phase 2, Multi-cohort, Open-label, Multi-center Study to Determine the Efficacy and Safety of bb2121 in Subjects with Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma Having Progressed Within One Year of Initial Treatment (KarMMa-2), Estudio fase II con varias cohortes, abierto, multicéntrico para determinar la eficacia y la seguridad del bb2121 en pacientes con mieloma múltiple en recaída y refractario, y en pacientes con mieloma múltiple de alto riesgo que han progresado durante un año desde el tratamiento inicial (KarMMa-2), Étude de phase II multicentrique, multi-cohortes, en ouvert, visant à déterminer l’efficacité et la sécurité du bb2121 chez des patients atteints d’un myélome multiple récidivant ou réfractaire et chez des patients atteints de myélome multiple à haut risque ayant évolué dans l’année suivant le traitement initial (KarMMa-2), Studio di fase 2, a coorti multiple, in aperto, multicentrico per valutare l’efficacia e la sicurezza di bb2121 in soggetti con Mieloma Multiplo recidivante e refrattario e in soggetti con Mieloma Multiplo ad alto rischio clinico (KarMMa-2) | |
| 2024-515279-37-00 | A Phase 3, Randomized, Open-Label, Multicenter Study to Compare the Efficacy and Safety of BMS-986393, a GPRC5D-directed CAR-T Cell Therapy, Versus Standard Regimens in Adult Participants with Relapsed or Refractory and Lenalidomide-refractory Multiple Myeloma | Celgene Corp. |
| 2018-001246-34 | A phase 1B/2, open-label, single arm, multicohort, multicenter trial to evaluate the safety and efficacy of JCAR017 in pediatric subjects with relapsed/refractory B-ALL and B-NHL, Étude de phase Ib/II multicentrique, multicohorte, à bras unique, en ouvert, évaluant l’innocuité et l’efficacité du JCAR017 chez des patients pédiatriques présentant une leucémie aigüe lymphoblastique à cellules B (LAL-B) ou un lymphome non hodgkinien à cellules B (LNH-B), récidivant ou réfractaire (r/r)., Étude de phase I/II multicentrique, multicohorte, à bras unique, en ouvert, évaluant la sécurité et l’efficacité du JCAR017 chez des patients pédiatriques présentant une LAL-B ou un LNH-B en rechute ou réfractaire (TRANSCEND PEDALL). , Estudio de fase Ib/II, multicéntrico, abierto, de un solo brazo y con varias cohortes para evaluar la seguridad y la eficacia de JCAR017 en pacientes pediátricos con leucemia linfoblástica aguda de células B (LLA-B) y linfoma no hodgkin de células B (LNH-B), recidivante/resistente (r/r) | |
| 2024-517681-41-00 | A Phase 1, Multicenter, Open-label Study of BMS-986515, Healthy Donor Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Autoimmune Diseases | Bristol-Myers Squibb Services Unlimited Company |
| 2018-001023-38 | A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of BB2121 Versus Standard Triplet Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (Rrmm) (KarMMa-3), Étude multicentrique de phase III, randomisée, en ouvert, visant à comparer l'efficacité et la sécurité de BB2121 aux trithérapies standard chez les patients atteints de myelome multiple récidivant ou réfractaire (MMRR) (KARMMA-3) , Studio di fase 3, multicentrico, randomizzato, in aperto per confrontare l’efficacia e la sicurezza di bb2121 rispetto ai regimi standard con tripletta in soggetti con mieloma multiplo recidivante e refrattario (RRMM) (KarMMa-3), Estudio fase III, multicéntrico, aleatorizado y abierto para comparar la eficacia y la seguridad de bb2121 frente a tripletes terapéuticos de referencia en pacientes con mieloma múltiple en recaída y refractario (MMRR) (KarMMa-3) | |
| 2023-507820-22-00 | A Phase 1, Multicenter, Single-arm, Dose-escalation Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T Chimeric Antigen Receptor (CAR) T Cells, Evaluating Safety and Tolerability in Participants with Relapsing Forms of Multiple Sclerosis (RMS) or Progressive Forms of Multiple Sclerosis (PMS) | Celgene Corp. |
| 2023-503823-24-01 | A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants with Severe, Refractory Systemic Lupus Erythematosus (SLE) | Celgene Corp. |
| 2022-501346-30-00 | A Randomized, Open-Label, Phase 3 Trial to Compare the Efficacy and Safety of Idecabtagene Vicleucel with Lenalidomide Maintenance Versus Lenalidomide Maintenance Therapy Alone in Adult Participants with Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation | Celgene Corp. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- 1) All adult and pediatric participants who received at least one GM T-cell infusion in a previous Celgene-sponsored or Celgene alliance partner-sponsored study, and have discontinued, or completed the post-treatment follow-up period in the parent treatment study, as applicable.
- 2) Participants (and parental/legal representative, when applicable) must understand and voluntarily sign an Informed Consent Form (ICF)/Informed Assent Form (IAF) prior to any study-related assessments/procedures being conducted.
Exclusion criteria 1
- Not Applicable.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 6
- Safety endpoints:Incidence of delayed adverse events considered at least possiblyrelated to GM T cell therapy(incl. lymphodepleting chemotherapy) (i.e. neurologic/autoimmune/hematologic disorders, infections, hospitalizations, etc.).
- Safety endpoints:Persistence of GM T-celldrug products, analysis of vector integration sites(Cohort 1), incidence of RCL(Cohort 1).
- Safety endpoints:Pediatrics only: Physical growth as assessed by physical examination and sexual maturity.
- Efficacy endpoints:Overall survival (subjects with original diagnosis of malignancies)
- Efficacy endpoints:Proportion of subjects who progressed on the study (subjects with original diagnosis of malignancies)
- The timeframe for safety and efficacy assessments is up to 15 years from last GM T-cell infusion. For pediatric participants will continue until they reach Tanner Stage 5. Assessments will start 3 months after the last GM T-cell infusion, then will continue at a frequency of once every 6 months until Month 60, and then once a year until the EOS.
Secondary endpoints 1
- Lymphocyte count (B-cell) for participants that received a liso-celGM T-cell therapy(Cohort 1).This assessment will be required up to 5 years from the last GM T-cell infusion (with the same frequency described for the primary endpoints); otherwise follow up continues for up to 15 years.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
Dual Targeting BCMAxGPRC5D CAR T
PRD11301397 · Product
- Active substance
- BMS986453
- Pharmaceutical form
- INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Dual Targeting BCMAxGPRC5D CAR T
PRD11301403 · Product
- Active substance
- BMS986453
- Pharmaceutical form
- INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Dual Targeting BCMAxGPRC5D CAR T
PRD11301257 · Product
- Active substance
- BMS986453
- Pharmaceutical form
- INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Dual Targeting BCMAxGPRC5D CAR T
PRD11301361 · Product
- Active substance
- BMS986453
- Pharmaceutical form
- INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Dual Targeting BCMAxGPRC5D CAR T
PRD11301315 · Product
- Active substance
- BMS986453
- Pharmaceutical form
- INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10384909 · Product
- Active substance
- Lisocabtagene Maraleucel
- Pharmaceutical form
- CELL SUSPENSION FOR INJECTION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10435579 · Product
- Active substance
- CC-97540
- Pharmaceutical form
- CELL SUSPENSION FOR INJECTION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD10119543 · Product
- Active substance
- Idecabtagene Vicleucel
- Pharmaceutical form
- CELL SUSPENSION FOR INJECTION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD11660738 · Product
- Active substance
- Arlocabtagene Autoleucel
- Substance synonyms
- Autologous T-cells expressing a chimeric antigenic receptor against GPRC5D, BMS-986393, CC-95266
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
HD Allogenic CD19-targeted CAR T
PRD11932112 · Product
- Active substance
- BMS-986515
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
HD Allogenic CD19-targeted CAR T
PRD11932034 · Product
- Active substance
- BMS-986515
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
HD Allogenic CD19-targeted CAR T
PRD11932318 · Product
- Active substance
- BMS-986515
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
HD Allogenic CD19-targeted CAR T
PRD11932790 · Product
- Active substance
- BMS-986515
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
HD Allogenic CD19-targeted CAR T
PRD11932123 · Product
- Active substance
- BMS-986515
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- OTHER USE
- Max daily dose
- 0 Other
- Max total dose
- 0 Other
- Max treatment duration
- 9999 Week(s)
- Authorisation status
- Not Authorised
- MA holder
- BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Third parties 5
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Other, Code 5 |
| Cellcarta ORG-100039881
|
Antwerp, Belgium | Other |
| Molecularmd Corp. ORG-100047559
|
Portland, United States | Other |
| Protagene Cgt GmbH ORG-100041450
|
Heidelberg, Germany | Other |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other |
Locations
17 EU/EEA countries · 117 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 8 | 4 |
| Belgium | Ongoing, recruiting | 15 | 6 |
| Czechia | Authorised, recruitment pending | 20 | 6 |
| Denmark | Authorised, recruitment pending | 9 | 4 |
| Finland | Ongoing, recruiting | 4 | 3 |
| France | Ongoing, recruiting | 45 | 15 |
| Germany | Ongoing, recruiting | 70 | 21 |
| Greece | Authorised, recruitment pending | 28 | 3 |
| Hungary | Authorised, recruitment pending | 8 | 2 |
| Italy | Ongoing, recruiting | 30 | 13 |
| Netherlands | Ongoing, recruiting | 11 | 6 |
| Norway | Ongoing, recruiting | 8 | 1 |
| Poland | Ongoing, recruiting | 34 | 6 |
| Portugal | Authorised, recruitment pending | 3 | 2 |
| Romania | Ongoing, recruiting | 20 | 3 |
| Spain | Ongoing, recruiting | 50 | 19 |
| Sweden | Ongoing, recruiting | 4 | 3 |
| Rest of world
United Kingdom, Canada, Switzerland, United States, Japan
|
— | 1,043 | — |
Investigational sites
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
3.Medizinische Abteilung – Abteilung für Hämatologie & Onkologie, Heinrich-Collin-Strasse 30, Penzing, Vienna
SCRI CCCIT Ges.m.b.H.
Klinik für Innere Medizin III PMU, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Elisabethinen I.Internal Depart., Hematology w. stem cell transpl., haemostaseology & med. oncology, Fadingerstrasse 1, 4020, Linz
Medical University Of Vienna
Department of Medicine I, Division of Hematology and Hemostaseology, Waehringer Guertel 18-20, Alsergrund, Vienna
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Universitair Ziekenhuis Gent
Department of Hematology, Corneel Heymanslaan 10, 9000, Gent
Institut Jules Bordet
Hematology, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Brussel
Hematology, Laarbeeklaan 101, 1090, Jette
Universitair Ziekenhuis Antwerpen
Neurology, Drie Eikenstraat 655, 2650, Edegem
UZ Leuven
Department of Hematology, Herestraat 49, 3000, Leuven
Vseobecna Fakultni Nemocnice V Praze
I.Interní klinika- klinika hematologie, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Brno
Interní hematologicko-onkologická klinika, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Ostrava
Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Hradec Kralove
IV.Interni hematologicka klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Fakultni Nemocnice Motol A Homolka
Oddeleni revmatologie deti a dospelych, V Uvalu 84/1, Motol, Prague
Revmatologicky Ustav
Oddeleni experimentalni revmatologie, Na Slupi 450/4, Nove Mesto, Prague 2
Odense University Hospital
Department of Hematology, J B Winsloews Vej 4, 5000, Odense C
Region Midtjylland
Department of Hematology, Palle Juul-Jensens Boulevard 99, 8200, Aarhus N
Region Sjaelland
Department of Hematology, Sygehusvej 10, 4000, Roskilde
Rigshospitalet
Department of Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
HUS Helsinki University Hospital
Comprehensive Cancer Center, Department of Oncology, Haartmaninkatu 4, 00290, Helsinki
Pohjois-Pohjanmaan hyvinvointialue
Oulu University Hospital, Kajaanintie 50, 90220, Oulu
Varsinais-Suomen hyvinvointialue
Turku University Hospital, Kiinamyllynkatu 4-8, 20520, Turku
Assistance Publique Hopitaux De Paris
Service de Neurologie, 43 Boulevard De L Hopital, 75013, Paris
Centre Hospitalier Universitaire De Rennes
Médecine Interne et Immunologie Clinique, 16 Boulevard De Bulgarie, Bp 90349, Rennes
Institut Gustave Roussy
Service d’Hématologie Clinique, 114 Rue Edouard Vaillant, 94800, Villejuif
Centre Hospitalier Universitaire De Bordeaux
Service d’hématologie clinique et de thérapie cellulaire, Avenue De Magellan, 33600, Pessac
Assistance Publique Hopitaux De Paris
Service Immuno-Hématologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Lyon Sud
Service d’Hématologie Clinique, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Centre Hospitalier Universitaire De Montpellier
Département d’Hématologie clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Hospital Hotel Dieu
Service d’Hématologie Clinique, 1 Place Alexis Ricordeau, 44000, Nantes
Centre Hospitalier Universitaire De Nice
Service de médecine interne, 151 Route De Saint Antoine, 06200, Nice
Assistance Publique Hopitaux De Paris
Service d’Hématologie Oncologie, 1 Avenue Claude Vellefaux, 75010, Paris
Les Hopitaux Universitaires De Strasbourg
Service de rhumatologie, 1 Avenue Moliere, Bp 49, Strasbourg Cedex 2
Centre Hospitalier Universitaire De Poitiers
Service d’Hematologie et Thérapie Cellulaire, 2 Rue De La Miletrie, 86000, Poitiers
Centre Hospitalier Universitaire de Lille
Service des Maladies du Sang, Rue Michel Polonovski, 59037, Lille
Assistance Publique Hopitaux De Paris
Unité d’hémopathie lymphoïdes, 51 Avenue Du Mal De Lattre De Tassigny, 94010, Creteil Cedex
Institut Universitaire Du Cancer Toulouse-Oncopole
Département d’Hématologie, 1 Avenue Irene Joliot Curie, 31059, Toulouse Cedex 9
Otto Von Guericke Universitaet Magdeburg
Department of Hematology, Oncology and Cell Therapy, Leipziger Strasse 44, Leipziger Str., Magdeburg
Medizinische Hochschule Hannover
Abteilung für Hämatologie, Hämostaseologie, Onkologie und Stammzelltransplantation, Carl-Neuberg-Strasse 1, Gross Buchholz, Hanover
Universitaetsklinikum Duesseldorf AöR
Klinik für Rheumatologie, Moorenstrasse 5, Bilk, Duesseldorf
Universitaetsklinikum Essen AöR
Neurology, Hufelandstrasse 55, Holsterhausen, Essen
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Medizinische Klinik und Poliklinik I, Fetscherstrasse 74, Johannstadt-Nord, Dresden
Charite Universitaetsmedizin Berlin KöR
Department of Rheumatology and Clinical Immunology, Chariteplatz 1, Mitte, Berlin
Universitaetsklinikum Frankfurt AöR
Universitätsklinikum Frankfurt AöR, Klinik für Kinder und Jugendmedizin, Theodor-Stern-Kai 7, 60590, Frankfurt Am Main
Klinikum Chemnitz gGmbH
Klinik für Innere Medizin III, Flemmingstrasse 2, Altendorf, Chemnitz
Universitaetsklinikum Wuerzburg AöR
Medizinische Klinik und Poliklinik II Zentrum Innere Medizin, Oberduerrbacher Strasse 6, Grombuehl, Wuerzburg
Universitaetsklinikum Ulm AöR
Klinik für Innere Medizin III Medizinische Klinik (Oberer Eselsberg) Ebene 1, Albert-Einstein-Allee 23, Eselsberg, Ulm
University Medical Center Hamburg-Eppendorf
Interdisziplinäre Klinik und Poliklinik für Stammzelltransplantation Zentrum für Onkologie, Martinistrasse 52, Eppendorf, Hamburg
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Medizinische Klinik und Poliklinik III, Ismaninger Strasse 22, Au-Haidhausen, Munich
Universitaetsklinikum Erlangen AöR
Department of Medicine 3, Ulmenweg 18, Innenstadt, Erlangen
Charite Universitaetsmedizin Berlin KöR
Campus Virchow-Klinikum (CVK), Augustenburger Platz 1, Wedding, Berlin
Klinikum der Universitaet Muenchen AöR
Medizinische Klinik II Campus Großhadern, Marchioninistrasse 15, Hadern, Munich
Universitaetsklinikum Regensburg AöR
Internal Medicine III, Hematology and Oncology, Franz-Josef-Strauss-Allee 11, Grass-Oberisling, Regensburg
Universitaetsklinikum Tuebingen AöR
Innere Medizin II, Otfried-Mueller-Strasse 10, Nordstadt, Tuebingen
Helios Klinikum Berlin-Buch GmbH
N/A, Schwanebecker Chaussee 50, Buch, Berlin
Staedtisches Klinikum Karlsruhe gGmbH
Department of Hematology, Oncology, Infectious Diseases and Palliative Medicine, Moltkestrasse 90, Weststadt, Karlsruhe
Universitaetsklinikum Heidelberg AöR
Medizinische Klinik V, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
University Hospital Cologne AöR
Klinik I für Innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
University General Hospital Attikon
2nd Department of Internal Medicine, Rimini Street 1, 124 62, Athens
Evaggelismos Hospital
Department of Hematology- Bone Marrow Transplantation Unit, Ipsiladou 45-47, 106 76, Athens
General University Hospital Of Patras
Department of Hematology, Bone Marrow Transplantation Unit, Rio, 265 04, Patras
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
Hematológiai és Őssejt-transzplantációs Osztály, Albert Florian Ut 5-7, 1097, Budapest IX
University Of Debrecen
Klinikai Központ, Belgyógyászati Klinika Hematológia, Nagyerdei Korut 98, 4032, Debrecen
Azienda Sanitaria Universitaria Friuli Centrale
Clinica Ematologica, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
IRCCS Ospedale Policlinico San Martino
Hematology and cell Therapy, Largo Rosanna Benzi 10, 16132, Genoa
ASST Grande Ospedale Metropolitano Niguarda
Reumathology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Humanitas Research Hospital
U.O. Oncologia Medica ed Ematologia - Humanitas Cancer Center, Via Alessandro Manzoni 56, 20089, Rozzano
Ospedale Pediatrico Bambino Gesu'
Dipartimento di Oncoematologia e Medicina Trasfusionale, Piazza Sant'onofrio 4, 00165, Rome
Fondazione IRCCS San Gerardo Dei Tintori
Centro Trapianti Midollo Osseo, Via Giovanni Battista Pergolesi 33, 20900, Monza
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Reumathology, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
SDD clinical Trial Office in Oncoematologia e Mieloma Multiplo/SC Hematology, Corso Bramante 88, 10126, Turin
Fondazione IRCCS Istituto Nazionale Dei Tumori
S.C. Ematologia - Dipartimento di Oncologia medica ed Ematologia, Via Giacomo Venezian 1, 20133, Milan
IRCCS Istituto Nazionale Tumori Fondazione Pascale
S.C. Ematologia Oncologica, Via Mariano Semmola 52, 80131, Naples
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
S.C. Ematologia - Dipartimento di Oncologia ed Ematologia, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera Papa Giovanni XXIII
SC Ematologia, Piazza Oms 1, 24127, Bergamo
Azienda Unita Sanitaria Locale Di Bologna
Unità Operativa di Ematologia, Via Giuseppe Massarenti 9, 40138, Bologna
Universitair Medisch Centrum Utrecht
Division: Beeld & Oncology Department: Hematology, Heidelberglaan 100, 3584 CX, Utrecht
Academisch Ziekenhuis Maastricht
Internal Medicine, division of Hematology, P Debyelaan 25, 6229 HX, Maastricht
Radboud universitair medisch centrum Stichting
Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Prinses Maxima Centrum voor Kinderoncologie B.V.
Princess Maxima Center for Pediatric Oncology, Heidelberglaan 25, 3584 CS, Utrecht
Amsterdam UMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Erasmus MC, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Szpital Specjalistyczny Nr I W Bytomiu SPZOZ
Oddział Reumatologii i Rehabilitacji, Ul. Stefana Zeromskiego 7, 41-902, Bytom
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Instytut Hematologii I Transfuzjologii
Instytut Hematologii i Transfuzjologii-SZPITAL W WARSZAWIE, Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematologii, Transplantologii i Chorób Wewnętrznych – Klinika Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli
Oddzial Hematologii i Transplantacji Szpiku, Ul. Dra Kazimierza Jaczewskiego 7, 20-090, Lublin
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Oddzial w Gliwicach, Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Unidade Local De Saude De Santa Maria E.P.E.
Reumatology, Avenida Professor Egas Moniz, 1649-035, Lisbon
Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
Reumatology, Rua Dr. Antonio Bernardino De Almeida, 4200-072, Porto
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Sectia Hematologie, Strada Republicii 34-36, 400015, Cluj-Napoca
Institutul Regional De Oncologie Iasi
Sectia Hematologie, Strada G-Ral Berthelot 2-4, 700483, Iasi
Institutul Clinic Fundeni
Sectia de Hematologie IV, Soseaua Fundeni 258, 022328, Bucharest
Clinica Universidad De Navarra
Servicio de Hematologia, Avenue Pio XII 36, 31008, Pamplona
Institut Catala D'oncologia
Servicio de Hematologia, Carretera Canyet S/n, 08916, Badalona
Hospital Clinic De Barcelona
Servicio de Hematologia, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario De Salamanca
Servicio de Hematologia, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Y Politecnico La Fe
Servicio de Neurologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
University Hospital Virgen Del Rocio S.L.
Servicio de Hematologia, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Universitario Regional De Malaga
Servicio de Reumatologia, Avenida De Carlos De Haya S/N, 29010, Malaga
Hospital Universitario 12 De Octubre
Servicio de Hematologia, Bloque D, Avenida De Cordoba S/n, Madrid
Hospital Infantil Universitario Nino Jesus
Servicio de Hematologia, Avenida De Menendez Pelayo 65, 28009, Madrid
Hospital Universitario Reina Sofia
Servicio de Reumatologia, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitari Vall D Hebron
Servicio de Hematologia, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Hospital Universitario Marques De Valdecilla
Servicio de Reumatologia, Avenida Valdecilla Sn, 39008, Santander
Hospital Universitario Virgen De Las Nieves
Servicio de Hematologia, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Complexo Hospitalario Universitario De Santiago
Servicio de Hematologia, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Ramon Y Cajal
Servicio de Neurologia, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital De La Santa Creu I Sant Pau
Servicio de Reumatologia, Carrer De San Quinti 89, 08041, Barcelona
University Hospital Son Espases
Servicio de Hematologia, Carretera Valldemossa 79, 07120, Palma
Hospital General Universitario Gregorio Maranon
Servicio de Hematologia, Calle Del Doctor Esquerdo 46, 28009, Madrid
Hospital Sant Joan De Deu Barcelona
Servicio de Reumatologia, Passeig De Sant Joan De Deu 2, 08950, Esplugues De Llobregat
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Hematology, Bla Straket 5, Goteborgs Annedal, Goteborg
Karolinska University Hospital
Center for Allogeneic Stem Cell Transplants (CAST), Halsovagen, Flemingsberg, Huddinge
Region Skane Skanes Universitetssjukhus
VO Hematologi, onkologi och Strålningsfysik, Entregatan 7, 222 42, Lund
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 |
|---|---|---|---|---|---|
| Austria | 2021-06-24 | 2021-10-28 | |||
| Belgium | 2020-03-03 | 2020-03-25 | |||
| Finland | 2020-09-15 | 2020-10-08 | |||
| France | 2018-12-21 | 2020-11-12 | |||
| Germany | 2021-11-23 | 2021-11-23 | |||
| Italy | 2020-10-30 | 2020-12-04 | |||
| Netherlands | 2021-01-06 | 2021-01-15 | |||
| Norway | 2025-02-04 | 2025-02-11 | |||
| Poland | 2025-02-21 | 2025-03-04 | |||
| Romania | 2025-01-20 | 2025-02-18 | |||
| Spain | 2019-07-05 | 2019-07-23 | |||
| Sweden | 2020-04-15 | 2021-01-28 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 162 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Benefit and Risk Assessment 2023-504201-36-00 _FP | 3.0 |
| Protocol (for publication) | D1_Benefit and Risk Assessment_GR_2023-504201-36-00_FP | 3.0 |
| Protocol (for publication) | D1_Protocol 2023-504201-36-00_Redacted | 4 |
| Protocol (for publication) | D1_Protocol Admin Letter_2023-504201-36-00_FP | 1 |
| Protocol (for publication) | D1_Protocol Admin Letter_2023-504201-36-00_Placeholder_GR_FP | N/A |
| Protocol (for publication) | D1_Protocol_GR_2023-504201-36-00_FP | 4 |
| Recruitment arrangements (for publication) | K1_ICF and Patient Recruitment Procedure_FP | 2 |
| Recruitment arrangements (for publication) | K1_Recruit arrang_ICF process_FP | 2 |
| Recruitment arrangements (for publication) | K1_Recruit Arrangements_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruit Process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit Process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruit-ICF Process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 2 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 3.0 |
| Recruitment arrangements (for publication) | K1_Recruit-ICF process_FP | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and IC procedure_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_FP | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment ICF process_FP | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment ICF process_FP | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment-ICF Procedure_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Card_en_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Patient Card_ro_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_Recruitment Materials_FP | N/A |
| Recruitment arrangements (for publication) | K2_Treating Physician Letter_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Children 12-15 ICF_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Main ICF_Adult_en_FP | 15.1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Main ICF_Adult_fr_FP | 15.1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Main ICF_Adult_nl_FP | 15.1 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Main_16 plus ICF_FP | 15.0 |
| Subject information and informed consent form (for publication) | L1_SIS ICF_Parent ICF_FP | 4 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Assent_12-15_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Assent_16-17_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS_ICF_Parents_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Assent 12-15_FP | 3 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Assent 16-17_FP | 5.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Assent 6-7_FP | 2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Assent 8-11_FP | 2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_FP | 14.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Main_FP | 12.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Parent_FP | 6.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Participant_en_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Participant_fr_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Participant_nl_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_en_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_fr_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Pregnant Partner_nl_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_ Assent 12-15y_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_ Assent-6-7y_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 15-17_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 16-17_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 16-17y_en_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 16-17y_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 16-17y_fr_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 16-17y_nl_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 16-18 aged_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent 8-11y_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent_12-15_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent_16-17_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Assent_6-11_FP | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Contact details for ICF_FP | 2 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Country Main_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_GDPR_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main Site 07601_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_en_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 9.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_FP | 8.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_ro_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Main_site 22003_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Opt Tissue Sample Adult_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Opt Tissue Sample Parent_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Optional consent for tissue sample_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Optional Research_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_en_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_FP | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_fr_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent_nl_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parent-Guardian_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parents_FP | 10.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parents-Legal Representatives_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Parents-Legal Representatives_site 22003_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregn Partner_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregn_Part_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregn_Pat_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Participant_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Participant_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Participant_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Participant_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Participant_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Participant_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_1_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_en_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 6.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant partner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 4.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Partner_ro_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Patient_en_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Patient_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Patient_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Patient_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Patient_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Pregnant Patient_ro_FP | 2.1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PregParticipant_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PregParticipant_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PregParticipant_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PregPartner_FP | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PregPartner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PregPartner_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_PregSubject_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Privacy form_FP | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Privacy form_Parent-Guardian_FP | 11.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout_Parents-Legal Representatives_site 22003_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF_Scout_site 22003_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_List of Submitted Documents_FP | N/A |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Leaflet_FP | N/A |
| Subject information and informed consent form (for publication) | L2_Patient Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card_FP | 1 |
| Subject information and informed consent form (for publication) | L2_Patient Card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_PFD_Email Comm_ERR_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_PFD_Scout Brochure_FP | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis AT_2023-504201-36-00_de_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BE_2023-504201-36-00_de_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BE_2023-504201-36-00_fr_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis BE_2023-504201-36-00_nl_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis DE_2023-504201-36-00_de_FP | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis ES_2023-504201-36-00_es_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis FR_2023-504201-36-00_fr_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis GR_2023-504201-36-00_el_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis IT_2023-504201-36-00_it_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL_2023-504201-36-00_nl_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NO_2023-504201-36-00_no_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis PL_2023-504201-36-00_pl_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis SE_2023-504201-36-00_sv_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2023-504201-36-00_en_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_CZ_2023-504201-36-00_cz_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_HU_2023-504201-36-00_hu_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PT_2023-504201-36-00_pt_FP | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_RO_2023-504201-36-00_ro_FP | 3 |
Application history
23 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-07-07 | Finland | Acceptable 2023-08-14
|
2023-08-14 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2023-12-22 | Finland | Acceptable 2024-03-11
|
2024-03-12 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-04-24 | Acceptable | 2024-05-16 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-04-24 | Acceptable | 2024-07-04 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-04-24 | Acceptable | 2024-07-12 | |
| 6 | SUBSEQUENT ADDITION OF MSC | APP-6 | 2024-05-02 | Acceptable 2024-03-11
|
2024-07-29 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-05-09 | Acceptable 2024-03-11
|
2024-07-31 | |
| 8 | SUBSEQUENT ADDITION OF MSC | APP-8 | 2024-06-06 | Acceptable 2024-03-11
|
2024-08-30 | |
| 9 | SUBSEQUENT ADDITION OF MSC | APP-9 | 2024-06-12 | Acceptable 2024-03-11
|
2024-09-09 | |
| 10 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-09-20 | Finland | Acceptable 2024-03-11
|
2024-09-20 |
| 11 | SUBSTANTIAL MODIFICATION | SM-5 | 2025-03-04 | Finland | Acceptable 2025-06-06
|
2025-06-06 |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2025-08-19 | Acceptable 2025-06-06
|
2025-10-31 | |
| 13 | SUBSEQUENT ADDITION OF MSC | APP-13 | 2025-08-19 | Acceptable 2025-06-06
|
2025-09-16 | |
| 14 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-08-20 | Acceptable | 2025-09-11 | |
| 15 | SUBSEQUENT ADDITION OF MSC | APP-15 | 2025-08-22 | 2025-10-27 | ||
| 16 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-08-22 | Acceptable | 2025-10-06 | |
| 17 | SUBSTANTIAL MODIFICATION | SM-7 | 2025-08-22 | Acceptable | 2025-09-22 | |
| 18 | SUBSTANTIAL MODIFICATION | SM-8 | 2025-08-22 | Acceptable | 2025-09-04 | |
| 19 | SUBSTANTIAL MODIFICATION | SM-9 | 2025-08-22 | Finland | Acceptable | 2025-09-22 |
| 20 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-08-22 | Acceptable | 2025-09-04 | |
| 21 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-08-22 | Acceptable | 2025-10-01 | |
| 22 | SUBSTANTIAL MODIFICATION | SM-13 | 2025-08-22 | Acceptable | 2025-09-15 | |
| 23 | SUBSTANTIAL MODIFICATION | SM-14 | 2025-12-12 | Finland | Acceptable 2026-03-24
|
2026-03-24 |