Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
108
Countries
7
Sites
19
Adult patients with follicular B-cell non-Hodgkin lymphoma grade 1-3A, relapsed or refractory after at least two prior lines of systemic therapy
To demonstrate superiority of the tisagenlecleucel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by blinded independent review committee (BIRC) based on the Lugano response criteria
Key facts
- Sponsor
- Novartis Pharma AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 2 Jan 2024 → ongoing
- Decision date (initial)
- 2024-12-09
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Novartis Pharma AG
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Therapy, Efficacy, Safety
To demonstrate superiority of the tisagenlecleucel treatment strategy over standard of care (SOC) therapy with respect to progression-free survival (PFS) determined by blinded independent review committee (BIRC) based on the Lugano response criteria
Secondary objectives 7
- To evaluate the tisagenlecleucel treatment strategy and the standard of care therapy with respect to complete response rate (CRR) by BIRC
- To evaluate the tisagenlecleucel treatment strategy and the standard of care therapy with respect to ● Overall response rate (ORR) by BIRC ● Overall survival (OS) ● Time to next anti-lymphoma treatment (TTNT)
- To evaluate duration of response on tisagenlecleucel treatment strategy and standard of care therapy
- To characterize the incidence and prevalence of tisagenlecleucel immunogenicity (humoral ) and impact on cellular kinetics, efficacy, and safety in participants receiving tisagenlecleucel therapy in arm A
- To evaluate the safety of the tisagenlecleucel treatment strategy and the standard of care therapy
- To characterize the in vivo cellular kinetics of tisagenlecleucel transduced cells into target tissues summarized by clinical response in participants receiving tisagenlecleucel therapy in arm A
- To assess presence of (Replication competent lentivirus) RCL in participants receiving tisagenlecleucel in arm A
Conditions and MedDRA coding
Adult patients with follicular B-cell non-Hodgkin lymphoma grade 1-3A, relapsed or refractory after at least two prior lines of systemic therapy
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10061170 | Follicle centre lymphoma follicular grade I II III | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- 1.Age ≥ 18 years at the date of signing the informed consent form.
- 2.Follicular lymphoma grade 1, 2, or 3A confirmed histologically after latest relapse (local assessment).
- 3.Relapsed or refractory disease after a second or later line of systemic therapy including an anti-CD20 antibody and an alkylating agent.
- 4.Disease that is both active on Positron emission tomography (PET) scan (defined as a score of 4 or 5 on the Deauville 5-point scale) and measurable on Computed tomography (CT) scan.
- 5.ECOG performance status of 0, 1 or 2 at screening.
- 6.Adequate hematologic, renal, hepatic and pulmonary organ function at screening.
- 7.Must meet the institutional criteria to undergo leukapheresis (unless historical leukapheresis is available).
- 8.Must be eligible for treatment with the selected standard of care regimen.
Exclusion criteria 7
- 1.Follicular lymphoma grade 3B or evidence of histologic transformation.
- 2.Prior treatment with anti-CD19 therapy, gene therapy, or adoptive T-cell therapy.
- 3.Active CNS involvement by malignancy.
- 4.Clinically significant active infection, presence of Human immunodeficiency virus (HIV) antibody or active hepatitis B or C.
- 5.Active neurological autoimmune or inflammatory disorders (e.g., Guillain-Barré syndrome).
- 6.Investigational medicinal product within the last 30 days or five half-lives (whichever is longer) prior to randomization.
- 7.Clinically significant cardiovascular conditions such as acute coronary syndrome, significant cardiac arrhythmias, heart failure or decreased LVEF.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- ●Progression free survival (PFS) based on Lugano response criteria, defined as time from randomization to the first of the following events to occur: ● progressive disease (by BIRC) ● death from any cause
Secondary endpoints 7
- ● Best overall response (BOR) as assessed by BIRC per Lugano response criteria. BOR is the best disease response observed from randomization until start of new anticancer therapy. ● CRR: The proportion of participants with BOR of complete response (CR)
- ● ORR: The proportion of participants with BOR of either CR or partial response (PR) ● OS: Time from randomization to date of death due to any cause ● TTNT: Time from randomization until start of new anticancer therapy or death due to any cause.
- ● Time from the date of first documented BIRC response of CR or PR to the date of first documented progression by BIRC or any cause of death
- ● Summary of pre-existing and treatment induced immunogenicity (humoral) of tisagenlecleucel ● Levels of pre-exis ting and treatment induced immunogenicity. Cellular kinetic parameters, concentration,-time profile, and efficacy by humoral immunogenicity.
- ● Type, frequency and severity of serious and non-serious adverse events (AEs) and laboratory abnormalities and discontinuations due to adverse events
- ● Summary of qPCR detected Chimeric Antigen Receptor (CAR) transgene levels in peripheral blood and bone marrow (and other tissues, if available) by timepoints and cellular kinetic parameters from peripheral blood transgene levels by clinical response status
- RCL by VSV-g qPCR
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SUB177825 · Substance
- Active substance
- Tisagenlecleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 600000000 DF dosage form
- Max total dose
- 600000000 DF dosage form
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/21/2464
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Quality will be the same as the authorized marketing authorization product (EU Marketing Authorization (MA) EU/1/18/1297/001), the modification to note is that the label text will be adapted to meet the clinical trial specificities.
Comparator 7
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg/m2 milligram(s)/sq. meter
- Max total dose
- 40 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The modification consists in re-labeling the commercial product with clinical label in applicable countries.
SUB25389 · Substance
- Active substance
- Lenalidomide
- Pharmaceutical form
- HARD CAPSULES
- Route of administration
- ORAL
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The modification consists in re-labeling the commercial product with clinical label in applicable countries.
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.4 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1.4 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The modification consists in re-labeling the commercial product with clinical label in applicable countries
SUB01827MIG · Substance
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 50 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The modification consists in re-labeling the commercial product with clinical label in applicable countries.
SUB16414MIG · Substance
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 750 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The modification consists in re-labeling the commercial product with clinical label in applicable countries.
SUB10018MIG · Substance
- Active substance
- Prednisolone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg/m2 milligram(s)/sq. meter
- Max total dose
- 40 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 375 mg/m2 milligram(s)/sq. meter
- Max total dose
- 375 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The modification consists in re-labeling the commercial product with clinical label in applicable countries.
Auxiliary 5
SUB20313 · Substance
- Active substance
- Tocilizumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 24 mg/kg milligram(s)/kilogram
- Max total dose
- 32 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
- Yes
- Modification description
- The modification consists in re-labeling the commercial product with clinical label in applicable countries
SUB00696MIG · Substance
- Active substance
- Bendamustine Hydrochloride
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 90 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB16414MIG · Substance
- Active substance
- Cyclophosphamide Monohydrate
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 250 mg/m2 milligram(s)/sq. meter
- Max total dose
- 750 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
-
H02AB · Product
- Pharmaceutical form
- PHF00231MIG
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB — GLUCOCORTICOIDS
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB13897MIG · Substance
- Active substance
- Fludarabine Phosphate
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION OR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 25 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Novartis Pharma AG
- Sponsor organisation
- Novartis Pharma AG
- Address
- Lichtstrasse 35
- City
- Basel Town
- Postcode
- 4056
- Country
- Switzerland
Scientific contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Public contact point
- Organisation
- Novartis Pharma AG
- Contact name
- Novartis Pharma Arzneimittel GmbH
Third parties 17
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International (IRL) Limited ORG-100022780
|
Dublin 2, Ireland | Other |
| Iqvia Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring |
| Eco-Abc Sp. z o. o. ORG-100046253
|
Belchatow, Poland | Code 14 |
| Statmed Sp. z o.o. ORG-100047187
|
Golkow, Poland | Code 14, Other |
| Alliance Healthcare Romania S.R.L. ORG-100034371
|
Rudeni, Romania | Code 14, Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other, Laboratory analysis |
| Komtur Polska Sp. z o.o. ORG-100036131
|
Warsaw, Poland | Code 14, Other |
| World Courier (U.K.) Limited ORG-100022287
|
Feltham, United Kingdom | Other |
| Syneos Health Inc. ORG-100008382
|
Morrisville, United States | On site monitoring |
| Labcorp Early Development Laboratories Limited ORG-100011365
|
Huntingdon, United Kingdom | Other, Laboratory analysis |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Interactive response technologies (IRT) |
| 4G Clinical B.V. ORG-100044721
|
Amsterdam, Netherlands | Interactive response technologies (IRT) |
| Labcorp Central Laboratory Services S.a.r.l. ORG-100011524
|
Meyrin, Switzerland | Other, Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring |
| Navigate Biopharma Services Inc. ORG-100032721
|
Carlsbad, United States | Other, Laboratory analysis |
| Pharmaceutical Research Associates Group B.V. ORG-100006268
|
Assen, Netherlands | Other, Laboratory analysis |
Locations
7 EU/EEA countries · 19 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruitment ended | 6 | 2 |
| Czechia | Ongoing, recruitment ended | 3 | 1 |
| Hungary | Ongoing, recruitment ended | 2 | 1 |
| Poland | Ongoing, recruitment ended | 8 | 4 |
| Romania | Ended | 3 | 1 |
| Slovakia | Ongoing, recruitment ended | 8 | 1 |
| Spain | Ongoing, recruitment ended | 28 | 9 |
| Rest of world
United States, Taiwan, Singapore, Canada, Australia, Korea, Republic of
|
— | 50 | — |
Investigational sites
SCRI CCCIT Ges.m.b.H.
Internal Medicine and Hematology, Muellner Hauptstrasse 48, 5020, Salzburg
Ordensklinikum Linz GmbH
Oncology/Haematology, Fadingerstrasse 1, 4020, Linz
Fakultni Nemocnice Ostrava
#2006:Hematologická klinika, 17. Listopadu 1790/5, 708 00, Poruba
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
#2000:Orszagos Hematologiai es Infektologiai Intezet, Albert Florian Ut 5-7, 1097, Budapest IX
Uniwersyteckie Centrum Kliniczne
#2024:Klinika Hematologii, Transplantologii i Terapii Komórkowych, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
#2022:Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im.M.Kopernika W Lodzi
#2025:Oddział Hematologii i Transplantologii - Klinika Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Uniwersytecki Szpital Kliniczny W Poznaniu
#2021:Klinika Hematologii, Transplantacji i Terapii Komórkowej, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Narodny Onkologicky Ustav
#2011:Oddelenie onkohematológie II, Klenova 1, Nove Mesto, Bratislava
University Clinical Hospital Virgen De La Arrixaca
#2030:Hematology, Carretera De Cartagena S/n, El Palmar, Murcia
Hospital Universitario Ramon Y Cajal
#2033:Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario De Salamanca
#2034:Hematology, Paseo De San Vicente 58-182, 37007, Salamanca
Hospital Universitario Marques De Valdecilla
#2029:Hematology, 5 Planta, Avenida Valdecilla S/n, Santander
Hospital De La Santa Creu I Sant Pau
#2035: Hematology, Calle De San Antonio Maria Claret 167, 08025, Barcelona
Catalan Institute Of Oncology
#2031:Hematology, Avinguda Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Complexo Hospitalario Universitario De Santiago
#2037:Hematology, Calle Choupana Da S/n, 15706, Santiago De Compostela
Hospital Universitario Reina Sofia
#2036:Hematology, Avenida Menendez Pidal S/n, 14004, Cordoba
Hospital Universitari Vall D Hebron
#2032:Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2025-10-02 | 2025-10-02 | 2025-11-03 | ||
| Czechia | 2024-10-09 | 2024-10-09 | 2025-02-11 | ||
| Hungary | 2024-06-21 | 2024-06-21 | 2024-09-11 | ||
| Poland | 2024-04-05 | 2024-04-05 | 2025-06-17 | ||
| Romania | 2025-04-23 | 2025-05-06 | 2025-04-23 | 2025-04-23 | |
| Slovakia | 2024-05-10 | 2024-05-10 | 2026-01-22 | ||
| Spain | 2024-01-02 | 2024-01-02 | 2025-11-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 110 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | Benefit Risk Assessment_1_English_Red | 06.02.2023 |
| Protocol (for publication) | D1_Protocol - Signature Page_2023-503452-27-00_1_English_Red | 02 |
| Protocol (for publication) | D1_Protocol_2023-503452-27-00_1_English_Red | 02 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements - Country_1_AT_English_NonRed | V1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_CZ_Czech_NonRed | V1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_ES_Spanish_NonRed | v3.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_HU_English_Red | 1.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_PL_Polish_NonRed | v.1.0 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_RO_Romanian_Red | 1 |
| Recruitment arrangements (for publication) | Recruitment Arrangements - Country_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | ICF - Additional Biomarkers_1_HU_Hungarian_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Additional Biomarkers_2_HU_Hungarian_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_CZ_Czech_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_ES_Spanish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_HU_Hungarian_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_PL_Polish_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_RO_Romanian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant participant_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant partner of participant_1_CZ_Czech_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant partner of participant_1_ES_Spanish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant partner of participant_1_HU_Hungarian_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant partner of participant_1_PL_Polish_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant partner of participant_1_RO_Romanian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | ICF - Follow up for pregnant partner of participant_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | ICF - Info Sheet Female Partner_1_CZ_Czech_NonRed | V00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Info Sheet Female Partner_1_ES_Spanish_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Info Sheet Female Partner_1_HU_Hungarian_Red | v00.00.00 |
| Subject information and informed consent form (for publication) | ICF - Info Sheet Female Partner_1_PL_Polish_NonRed | 00.00.01 |
| Subject information and informed consent form (for publication) | ICF - Info Sheet Female Partner_1_RO_Romanian_Red | 00.00.01 |
| Subject information and informed consent form (for publication) | ICF - Info Sheet Female Partner_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | ICF - Main ICF Exceptional Release - OOS product_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | ICF - Separate Data Protection Consent_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | ICF - Separate Data Protection Consent_2_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | ICF -Optional treatment beyond disease progression 1_1_CZ_Czech_NonRed | V00.01.00 |
| Subject information and informed consent form (for publication) | ICF Procedure_1_ES_Spanish_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | ICF Procedure_1_PL_Polish_Red | v.1.0 |
| Subject information and informed consent form (for publication) | ICF Procedure_1_SK_Slovak_NonRed | V1 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant participant_1_AT_German_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Follow up for pregnant partner of participant_1_AT_German_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Info Sheet Female Partner_1_AT_German_NonRed | v00.00.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_AT_German_Red | v02.04.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_CZ_Czech_Red | V02.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_ES_Spanish_NonRed | v02.04.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_HU_Hungarian_Red | v02.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_PL_Polish_NonRed | v02.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_RO_Romanian_NonRed | v02.04.04 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_1_SK_Slovak_Red | 02.04.04.M |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_AT_German_NonRed | v01.02.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF - Adult_2_CZ_Czech_Red | V02.04.03 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF Exceptional Release - OOS product_1_AT_German_NonRed | v01.01.00 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF Exceptional Release - OOS product_1_CZ_Czech_NonRed | V01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF Exceptional Release - OOS product_1_ES_Spanish_NonRed | v01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF Exceptional Release - OOS product_1_HU_Hungarian_NonRed | v01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF Exceptional Release - OOS product_1_HU_Hungarian_Tc_NonRed | v01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF Exceptional Release - OOS product_1_PL_Polish_NonRed | v.01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF Exceptional Release - OOS product_1_RO_Romanian_Red | v01.01.02 |
| Subject information and informed consent form (for publication) | L1_ICF - Main ICF Exceptional Release - OOS product_2_CZ_Czech_NonRed | V01.01.01 |
| Subject information and informed consent form (for publication) | L1_ICF - Separate Data Protection Consent_1_CZ_Czech_NonRed | V00.01.00 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents Part II_1_CZ_NonRed | V2.0 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents_1_HU_Hungarian_NonRed | 06Jun2024 |
| Subject information and informed consent form (for publication) | L1_List of submitted documents_2_HU_NonRed | 18Dec2025 |
| Subject information and informed consent form (for publication) | L1_Patient Card_1_German_NonRed | v1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Info Sheet or Other Info_1_AT_German_Red | v02 |
| Subject information and informed consent form (for publication) | Subject Info Sheet or Other Info_1_RO_Romanian_Red | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Local Label_1_CTL019_RO_Romanian_NonRed | 06Apr2021 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Local Label_1_CTL019_RO_Romanian_NonRed | 04Apr2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference Label_1_CTL019_English_NonRed | 01Sep2021 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference Label_1_CTL019_English_NonRed | 16Apr2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference Label_1_CTL019_English_NonRed | 05Feb2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference Label_1_CTL019_English_Soc_NonRed | 16Apr2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Rituximab_English_NonRed | 21Oct2024 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_Reference SmPC_1_Vincristine_English_NonRed | 18Sep2024 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Cyclophoph_4_CZ_Czech_NonRed | 2022.02.24 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Cyclophoph_4_HU_Hungarian_NonRed | 29Mar2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Cyclophoph_4_PL_Polish_NonRed | 3/30/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Cyclophoph_4_SK_Slovak_NonRed | 3/24/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Doxorubicin_5_CZ_Czech_NonRed | 4/25/2022 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Doxorubicin_5_HU_Hungarian_NonRed | 29MAr2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Doxorubicin_5_PL_Polish_NonRed | 3/30/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Doxorubicin_5_SK_Slovak_NonRed | 3/30/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Lenalidomide_2_CZ_Czech_NonRed | 1/1/1900 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Lenalidomide_2_HU_Hungarian_NonRed | 29Mar2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Lenalidomide_2_PL_Polish_NonRed | 3/30/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Lenalidomide_2_SK_Slovak_NonRed | 3/18/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Prednisolone_7_HU_Hungarian_NonRed | 30Mar2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Prednisone_8_CZ_Czech_NonRed | 01.07.2021 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Prednisone_8_PL_Polish_NonRed | 3/30/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Prednisone_8_SK_Slovak_NonRed | 3/24/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Rituximab_3_CZ_Czech_NonRed | 1/1/1990 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Rituximab_3_HU_Hungarian_NonRed | 29MAr2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Rituximab_3_PL_Polish_NonRed | 2023.03.30 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Rituximab_3_SK_Slovak_NonRed | 2023.03.18 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Vincristine_6_CZ_Czech_NonRed | 11/25/2022 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Vincristine_6_HU_Hungarian_NonRed | 29Mar2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Vincristine_6_PL_Polish_NonRed | 3/30/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_1_Vincristine_6_SK_Slovak_NonRed | 3/24/2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_2_Lenalidomide_2_HU_Hungarian_NonRed | 31Mar2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Local Label_2_Rituximab_3_HU_Hungarian_NonRed | 29MAr2023 |
| Summary of Product Characteristics (SmPC) (for publication) | Reference Label_1_Cyclophoph_4_English_NonRed | 7.6.2016 |
| Summary of Product Characteristics (SmPC) (for publication) | Reference Label_1_Prednisolone_7_English_NonRed | 24.2.2022 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-503452-27-00_1_Czech_Red | V2.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-503452-27-00_1_German_Red | v02 |
| Synopsis of the protocol (for publication) | D1_Protocol Summary in Technical Language_2023-503452-27-00_1_Hungarian_Red | v02.01 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Czech_NonRed | 0 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_English_NonRed | 0 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Hungarian_NonRed | v00 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Polish_NonRed | v01 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Romanian_NonRed | v00 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Slovak_NonRed | V1 |
| Synopsis of the protocol (for publication) | Protocol Summary in Lay Language_1_Spanish_NonRed | v00 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-04-28 | Czechia | Acceptable 2023-08-21
|
2023-08-22 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-04-19 | Czechia | Acceptable 2023-08-21
|
2024-04-19 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-05-14 | Czechia | Acceptable 2024-08-15
|
2024-08-15 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2024-09-12 | Acceptable 2023-08-21
|
2024-12-09 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-01-22 | Czechia | Acceptable 2025-04-24
|
2025-04-24 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-11-05 | Czechia | Acceptable 2026-02-09
|
2026-02-09 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-23 | Acceptable 2026-02-09
|
2026-03-23 |