Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
256
Countries
10
Sites
27
B-Cell Non-Hodgkin's Lymphoma
To compare the efficacy, as defined by EFS, in participants treated with odronextamab versus participants treated with Standard of Care (SOC)
Key facts
- Sponsor
- Regeneron Pharmaceuticals Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 20 Feb 2024 → ongoing
- Decision date (initial)
- 2023-09-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- Regeneron Pharmaceuticals, Inc.
External identifiers
- EU CT number
- 2022-502783-21-00
- ClinicalTrials.gov
- NCT06230224
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety
To compare the efficacy, as defined by EFS, in participants treated with odronextamab versus participants treated with Standard of Care (SOC)
Secondary objectives 9
- To compare additional measures of efficacy for odronextamab versus SOC therapy
- To compare the treatment effects on patient-reported physical function between odronextamab monotherapy versus SOC
- To compare supplemental measures of efficacy for odronextamab versus SOC therapy
- To assess safety and tolerability of odronextamab monotherapy versus SOC
- To assess the pharmacokinetic (PK) of odronextamab monotherapy
- To assess the immunogenicity of odronextamab monotherapy
- To compare measurable residual disease (MRD) of odronextamab monotherapy versus SOC
- To compare the effect of odronextamab monotherapy versus SOC on PROs, including Health-Related Quality of Life (HRQoL), symptoms and functioning
- To evaluate the patient-reported overall impact of treatment toxicity of odronextamab monotherapy versus SOC
Conditions and MedDRA coding
B-Cell Non-Hodgkin's Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10029609 | Non-Hodgkin's lymphoma unspecified histology aggressive recurrent | 100000004864 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomized To compare event-free survival of odronextamab monotherapy (arm 1) versus SOC (arm 2; salvage therapy followed by autologous stem cell transplant [ASCT]) for participants with relapsed/refractory (R/R) aggressive B-NHL
|
Randomised Controlled | None | Odronextamab: Participants will receive odronextamab monotherapy. Standard of Care (SOC): Participants will receive salvage therapy (ifosfamide, carboplatin, etoposide ± rituximab [ICE ± R], or dexamethasone, cisplatin, cytarabine ± rituximab [DHAP ± R], or gemcitabine, dexamethasone, cisplatin ± rituximab [GDP ± R]) and continue with autologous stem cell transplant (ASCT) following a complete response (CR)/partial response (PR). |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Histologically proven aggressive B-NHL, as described in the protocol. Availability of tumor tissue for submission to central laboratory is required for study enrollment. Archival tumor tissue for histological assessment prior to enrollment is allowed.
- Have primary refractory or relapse 12 months or less (≤) from initiation of frontline therapy. Only patients who received 1 prior line of therapy containing an anti-Cluster of Differentiation 20 (CD20) antibody and anthracycline are allowed for enrollment
- Have measurable disease with at least one nodal lesion with longer diameter (LDi) greater than 1.5 cm or at least one extranodal lesion with LDi greater than 1.0 cm, documented by diagnostic imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
- Intent to proceed to autologous stem cell transplant (ASCT), as described in the protocol
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
- Adequate hematologic and organ function.
- Other protocol defined inclusion criteria apply
Exclusion criteria 7
- Primary central nervous system (CNS) lymphoma or known involvement by non-primary CNS NHL, as described in the protocol
- History of or current relevant CNS pathology, as described in the protocol
- A malignancy other than NHL unless the participant is adequately and definitively treated and is cancer free for at least 3 years, with the exception of localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that was definitively treated
- Any other significant active disease or medical condition that could interfere with the conduct of the study or put the participant at significant risk, as described in the protocol
- Wash-out period from prior anti-lymphoma treatments and infections, as described in the protocol
- Allergy/hypersensitivity to study drug, or excipients.
- Other protocol defined exclusion criteria apply
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Event-free survival (EFS) as assessed by independent central review (ICR)
Secondary endpoints 20
- Progression free survival (PFS) as assessed by ICR
- Best overall response (BOR) as assessed by ICR
- Overall survival (OS)
- Overall change in physical functioning as measured by scores of the physical function scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC-QLQ-C30)
- EFS as assessed by local investigator
- PFS as assessed by local investigator
- BOR as assessed by local investigator
- Complete response (CR) assessed by ICR and local investigator
- Duration of response (DOR) assessed by ICR and local investigator
- Incidence of treatment-emergent adverse events (TEAEs)
- Severity of TEAEs
- Odronextamab concentrations in serum
- Incidence of anti-drug antibodies (ADAs) to odronextamab over the study duration
- Titers of ADAs to odronextamab over the study duration
- Incidence of neutralizing antibodies (NAb) to odronextamab over the study duration
- Measurable residual disease (MRD) status
- Overall change in patient-reported outcomes (PROs), as measured by scores of the EORTCQLQ- C30
- Overall change in PROs, as measured by scores of the Functional Assessment of Cancer Therapy–Lymphoma (FACT-LymS)
- Overall change in PROs, as measured by scores of the EuroQol-5 Dimension-5 Level Scale (EQ-5D-5L)
- Overall change in score of the Global Population item 5 (GP5) of the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10211518 · Product
- Active substance
- Odronextamab
- Substance synonyms
- Human anti-CD20 x anti-CD3 bispecific monoclonal antibody, Human IgG4-based anti-CD20 x anti-CD3 bispecific monoclonal antibody, REGN1979, Anti-CD20/CD3 monoclonal antibody REGN1979
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- ATC code
- L01FX34 — -
- MA holder
- REGENERON PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2656
PRD10165768 · Product
- Active substance
- Odronextamab
- Substance synonyms
- Human anti-CD20 x anti-CD3 bispecific monoclonal antibody, Human IgG4-based anti-CD20 x anti-CD3 bispecific monoclonal antibody, REGN1979, Anti-CD20/CD3 monoclonal antibody REGN1979
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 320 mg milligram(s)
- Max total dose
- 320 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Not Authorised
- ATC code
- L01FX34 — -
- MA holder
- REGENERON PHARMACEUTICALS, INC.
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/22/2656
Comparator 10
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07017MIG · Substance
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07337MIG · Substance
- Active substance
- Etoposide
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07483MIG · Substance
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08125MIG · Substance
- Active substance
- Ifosfamide
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 gm/m2 gram(s)/square meter
- Max total dose
- 5 gm/m2 gram(s)/square meter
- Max treatment duration
- 9 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
- 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
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06614MIG · Substance
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 800 mg/m2 milligram(s)/sq. meter
- Max total dose
- 800 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 1 mg/m2 milligram(s)/square meter
- Max total dose
- 1 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07892MIG · Substance
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 1 gm/m2 gram(s)/square meter
- Max total dose
- 1 gm/m2 gram(s)/square meter
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4 gm/m2 gram(s)/square meter
- Max total dose
- 4 gm/m2 gram(s)/square meter
- Max treatment duration
- 9 Week(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
Regeneron Pharmaceuticals Inc.
- Sponsor organisation
- Regeneron Pharmaceuticals Inc.
- Address
- 777 Old Saw Mill River Road
- City
- Tarrytown
- Postcode
- 10591-6717
- Country
- United States
Scientific contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Head EU Regulatory Affairs
Public contact point
- Organisation
- Regeneron Pharmaceuticals Inc.
- Contact name
- Head EU Regulatory Affairs
Third parties 13
| Organisation | City, country | Duties |
|---|---|---|
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | On site monitoring, Code 12, Code 2, Code 5, Code 8 |
| Millmount Healthcare Limited ORG-100011724
|
Stamullen, Ireland | Code 14, Other |
| Fisher Clinical Services Inc. ORG-100014726
|
Mount Prospect, United States | Code 14 |
| IQVIA Laboratories LLC ORG-100043195
|
Durham, United States | Other, Code 5, Data management |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other, Code 5, E-data capture, Code 8 |
| Transperfect Translations International Inc. ORG-100043494
|
New York, United States | Other |
| Roche Sequencing Solutions Inc. ORG-100051131
|
Pleasanton, United States | Laboratory analysis |
| Bioclinica Inc. ORG-100033079
|
Philadelphia, United States | Other, Code 5, Data management |
| Clariness GmbH ORG-100045306
|
Hamburg, Germany | Other |
| FACIT.Org Inc. ORG-100048771
|
Ponte Vedra, United States | Other |
| European Organisation For Research And Treatment Of Cancer ORG-100010848
|
Sint-Lambrechts-Woluwe, Belgium | Other |
| PCI Pharma Services Germany GmbH ORG-100031981
|
Großbeeren, Germany | Code 14, Other |
| Perceptive Informatics Inc. ORG-100013171
|
Billerica, United States | Interactive response technologies (IRT) |
Locations
10 EU/EEA countries · 27 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ended | 10 | 2 |
| Belgium | Ended | 7 | 4 |
| Czechia | Ended | 4 | 1 |
| Germany | Ended | 2 | 1 |
| Hungary | Authorised, recruitment pending | 6 | 3 |
| Italy | Ended | 25 | 7 |
| Netherlands | Ended | 8 | 2 |
| Poland | Ended | 11 | 1 |
| Romania | Ongoing, recruitment ended | 25 | 2 |
| Spain | Ongoing, recruitment ended | 34 | 4 |
| Rest of world
Australia, Malaysia, United Kingdom, Thailand, Taiwan, Chile, Brazil, Korea, Democratic People's Republic of, Argentina, Turkey, Switzerland, Singapore, Israel
|
— | 124 | — |
Investigational sites
Kepler University Clinic Med Campus III.
Internal Medicine III – Hematology and Internal Oncology, Krankenhausstraße 9, A-4021, Linz
Steiermärkische Krankenanstaltengesellschaft m.b.H. LKH Hochsteiermark Standort Leoben
Department of Internal Medicine Division for Hemato-Oncology, Abteilung für Innere Medizin und Hämatologie und internistische Onkologie Vordernbergerstrasse 42, 8700, Leoben
Het Ziekenhuisnetwerk Antwerpen
Departement of Hematology, Lindendreef 1, 2020, Antwerp
Institut Jules Bordet
Departement of Hematology, Mijlenmeersstraat 90, 1070, Brussels
CHU UCL Namur
Departement of Hematology, Avenue Dr-Gaston-Therasse 1, 5530, Yvoir
Universitair Ziekenhuis Gent
Departement of Hematology, Corneel Heymanslaan 10, 9000, Gent
Fakultni Nemocnice Kralovske Vinohrady
Hematologicka klinika, Srobarova 1150/50, Vinohrady, Prague 10
Klinikum Frankfurt (Oder) GmbH
Medizinische Klinik I: Haematologie und Onkologie, Muellroser Chaussee 7, Markendorf, Frankfurt (oder)
University Of Pecs
Klinikai Központ, I. Sz. Belgyógyászati Klinika, Hematológiai Osztály, Ifjusag Utja 13, 7624, Pecs
Semmelweis University
Belgyógyászati és Hematológiai Klinika, Szentkiralyi Utca 46, VIII Kerulet, Budapest VIII
University Of Debrecen
Klinikai Központ, Belgyógyászati Klinika Hematológia, Nagyerdei Korut 98, 4032, Debrecen
Ospedale S. Eugenio
U.O.C. Ematologia, P. le dell'Umanesimo, 10, Roma
Azienda Ospedaliera Ospedale Di Circolo E Fondazione Macchi
S.C. Ematologia, Viale Luigi Borri 57, 21100, Varese
Azienda Ospedaliero-Universitaria Maggiore Della Carita
S.C.D.U. Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
U.O Ematologia, Piazzale Spedali Civili 1, 25123, Brescia
Centro Di Riferimento Oncologico Di Aviano
CRO Aviano, Via Franco Gallini 2, 33081, Aviano
Azienda Ospedaliera Universitaria Senese
UOC Ematologia, Strada Delle Scotte 14, 53100, Siena
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia Medica, Via Piero Maroncelli 40, 47014, Meldola
Spaarne Gasthuis Stichting
Internal Medicine, Spaarnepoort 1, 2134 TM, Hoofddorp
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Hematology, Dr. Molewaterplein 40, 3015 GD, Rotterdam
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
Szpital Instytutu w Warszawie, Ul. Wilhelma Konrada Roentgena 5, 02-781, Warsaw
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Hematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Spitalul Clinic Coltea
Hematology, Bulevardul Bratianu C. Ion 1-3, 030171, Bucharest
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Virgen De Las Nieves
Hematology, Avenida De Las Fuerzas Armadas 2, 18014, Granada
Clinica Universidad De Navarra
Hematology, Avenue Pio XII 36, 31008, Pamplona
Clinica Universidad De Navarra
Hematology, Calle Marquesado De Santa Marta 1, 28027, Madrid
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 |
|---|---|---|---|---|---|
| Romania | 2025-11-18 | 2025-11-18 | 2026-04-10 | ||
| Spain | 2024-02-20 | 2024-02-20 | 2026-04-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 129 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol Oncology Imaging Services Site Manual Redacted | 1 |
| Protocol (for publication) | D1_Protocol_EN 2022-502783-21-00_redacted | 2.0 |
| Protocol (for publication) | D4_Screen Reports_CZ_Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_DE_Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_deAT_Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_deBE_Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_EN Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_ES_Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_frBE_Redacted | 1 |
| Protocol (for publication) | D4_screen reports_HU_Redacted | 1.0 |
| Protocol (for publication) | D4_Screen Reports_IT Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_NL_Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_nLBE Redacted | 1 |
| Protocol (for publication) | D4_Screen Reports_PL Redacted | 1 |
| Protocol (for publication) | D4_screen reports_RO_Redacted | 1 |
| Protocol (for publication) | D4_SQRG HU | 1.0 |
| Protocol (for publication) | D4_SQRG_AT | 1 |
| Protocol (for publication) | D4_SQRG_CZ | 1 |
| Protocol (for publication) | D4_SQRG_DE | 1 |
| Protocol (for publication) | D4_SQRG_deBE | 1 |
| Protocol (for publication) | D4_SQRG_EN | 1 |
| Protocol (for publication) | D4_SQRG_ES | 1 |
| Protocol (for publication) | D4_SQRG_frBE | 1 |
| Protocol (for publication) | D4_SQRG_IT | 1 |
| Protocol (for publication) | D4_SQRG_NL | 1 |
| Protocol (for publication) | D4_SQRG_nlBE | 1 |
| Protocol (for publication) | D4_SQRG_PL | 1 |
| Protocol (for publication) | D4_SQRG_RO | 1 |
| Recruitment arrangements (for publication) | K1_R1979_Recruitment and Informed Consent Plan_FP | 3.0 |
| Recruitment arrangements (for publication) | K1_R1979-HM-2299_IC_Recruitment Procedure_FP | 2.0 |
| Recruitment arrangements (for publication) | K1_R1979-HM-2299_Recruit Material Statement | 2 |
| Recruitment arrangements (for publication) | K1_R1979-HM-2299_Recruit-ICF process | 1.0 |
| Recruitment arrangements (for publication) | K1_R1979-HM-2299_Recruit-ICF process_FP | 3.0 |
| Recruitment arrangements (for publication) | K1_R1979-HM-2299_Recruitment and Informed Consent_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979_HM-2299_Patient email_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Banner Ads Layout_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Banner Ads_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Banner ads_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_CSSi initial pre-screener_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_DEI page_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_DEI Website_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Digital Ads_FP | 0.9 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Digital Ads_Olympia 4_FP | 0.9 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Digital aids_FP | 0.9 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Diversity Website_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Initial Prescreener_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Initial Prescreener_FP | 0.2 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Leaflet Layout_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Patient Email Layout_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Patient Email_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Poster Layout_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Poster layout_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Poster_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Prescreener Form_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Program website_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Program Website_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruit mat_Banner Ads Layout_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruit mat_Patient Email Layout_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruit mat_Poster Layout_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruit mat_Storyboard_FP | 3 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruit mat_Study Brochure Layout_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruitment Leaflet_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruitment Leaflet_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruitment leaflet_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruitment material Banner Ads layout_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruitment material Patient Email Layout_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruitment material Poster layout_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruitment material Study Brochure Layout_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Recruitment Material_storyb_FP | 3 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Simpleshow StoryBoard_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Social Media Toolkit_FP | 0.9 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Storyboard_FP | 3 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Study Brochure Layout_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Study Brochure_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Study Brochure_FP | 3.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Study website_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Study Website_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Study Website_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Video Storyboard_FP | 3 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Website about O4_FP | 2.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Website DEI Page_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Website programmatic pages_FP | 1.0 |
| Recruitment arrangements (for publication) | K2_R1979-HM-2299_Website Programmatic Pages_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Clincierge | N/A |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_CLINCIERGE ICF | 1 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Clincierge_ita_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_FBR | 1 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_FBR ICF | 3.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_FBR_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_FBR_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_MAIN ICF | 5.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Main_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Main_FP | 2.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Main_Part 1 | 1.2 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Main_Part 2 | 2.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Main1 | 4.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Main2 | N/A |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_PGx | 1 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_PGx ICF | 3.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_PGX_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_PGx_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_PP | 1 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_PP ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_PP ICF_ES_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_PP_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Pregnant P_FP | 1.0 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Pregnant Partner | 1.1 |
| Subject information and informed consent form (for publication) | L1_R1979-HM-2299_SIS-ICF_Privacy | 2.0 |
| Subject information and informed consent form (for publication) | L2_R1979-HM-2299_Patient card_FP | 1.0 |
| Subject information and informed consent form (for publication) | L2_R1979-HM-2299_Subject ID Card_FP | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_gemcitabine_Hikma | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Dexamethasone_IV | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_cisplatin | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_cytarabine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_dexamethasone Galen Tablets | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_etoposide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_etoposide_Hikma | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_gemcitabine | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Ifosfamide | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_rituximab | 1.0 |
| Synopsis of the protocol (for publication) | D1_PLPS_EN 2022-502783-21-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_PLPS_EN 2022-502783-21-00_TC | 1.0 |
| Synopsis of the protocol (for publication) | D1_PLPS_ES 2022-5027853-21-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_PLPS_HU 2022-502783-21-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_PLPS_IT 2022-5027853-21-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_PLPS_NL_2022 502783 21 00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_PLPS_PL 2022-5027853-21-00 | 1.0 |
| Synopsis of the protocol (for publication) | D1_PLPS_RO 2022-502783-21-00 | 1.0 |
Application history
17 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-05-26 | Spain | Acceptable 2023-09-11
|
2023-09-11 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-01-17 | Spain | Acceptable 2023-09-11
|
2024-01-17 |
| 3 | SUBSTANTIAL MODIFICATION | SM-7 | 2024-01-29 | Spain | Acceptable | 2024-02-19 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2024-02-01 | Acceptable | 2024-04-04 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-02-06 | Acceptable | 2024-05-10 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2024-02-06 | Acceptable | 2024-03-20 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2024-02-20 | Acceptable 2023-09-11
|
2024-05-14 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-8 | 2024-02-29 | Acceptable | 2024-04-12 | |
| 9 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-03-01 | Acceptable | 2024-04-11 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-9 | 2024-10-18 | Spain | Acceptable 2025-01-29
|
2025-01-29 |
| 11 | SUBSTANTIAL MODIFICATION | SM-10 | 2025-02-21 | Spain | Acceptable | 2025-03-19 |
| 12 | SUBSEQUENT ADDITION OF MSC | APP-12 | 2025-02-24 | Acceptable 2025-01-29
|
2025-05-06 | |
| 13 | SUBSTANTIAL MODIFICATION | SM-11 | 2025-02-24 | Acceptable | 2025-04-04 | |
| 14 | SUBSEQUENT ADDITION OF MSC | APP-14 | 2025-02-28 | Acceptable 2025-01-29
|
2025-05-26 | |
| 15 | SUBSTANTIAL MODIFICATION | SM-12 | 2025-08-14 | Spain | Acceptable 2025-09-29
|
2025-09-30 |
| 16 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-02-02 | Spain | Acceptable 2025-09-29
|
2026-02-02 |
| 17 | SUBSTANTIAL MODIFICATION | SM-13 | 2026-03-16 | Spain | Acceptable 2026-05-18
|
2026-05-19 |