Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
639
Countries
11
Sites
70
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)
Progression-free survival
Key facts
- Sponsor
- Loxo Oncology Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 14 Oct 2021 → ongoing
- Decision date (initial)
- 2024-06-17
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- Yes
- Funding sources
- Loxo Oncology, Inc. a wholly owned subsidiary of Eli Lilly and Company
External identifiers
- EU CT number
- 2023-507698-16-00
- EudraCT number
- 2021-000043-49
- WHO UTN
- U1111-1300-5619
- ClinicalTrials.gov
- NCT04965493
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Safety
Progression-free survival
Conditions and MedDRA coding
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (BRUIN CLL-322)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- Age 18 and older at time of enrollment
- Confirmed diagnosis of CLL/SLL requiring therapy per iwCLL 2018 criteria
- Previous treatment with at least one line of therapy that may include a covalent Bruton's tyrosine kinase (BTK) inhibitor
- Platelets greater than or equal to (≥)50 x 10⁹/liter (L), hemoglobin ≥8 grams/deciliter (g/dL) and absolute neutrophil count ≥1.0 x 10⁹/L
- Adequate organ function
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
- Estimated creatinine clearance ≥30 milliliters per minute (mL/min)
Exclusion criteria 15
- Known or suspected Richter's transformation at any time preceding enrollment
- Prior therapy with a non-covalent (reversible) BTK inhibitor
- Patients requiring therapeutic anticoagulation with warfarin or another Vitamin K antagonist
- Current treatment with strong cytochrome P450 (CYP) 3A4 (CYP3A4) inhibitors or inducers
- Prior therapy with venetoclax
- Central nervous system (CNS) involvement
- Active uncontrolled systemic bacterial, viral, fungal, or parasitic infection
- Known human immunodeficiency virus (HIV) infection, regardless of cluster of differentiation 4 (CD4) count
- Allogeneic stem cell transplantation (SCT) or chimeric antigen receptor (CAR)-T within 60 days
- Active hepatitis B or hepatitis C
- Known active cytomegalovirus (CMV) infection
- Uncontrolled immune thrombocytopenic purpura (ITP) or autoimmune hemolytic anemia (AIHA)
- Significant cardiovascular disease
- Vaccination with a live vaccine within 28 days prior to randomization
- Patients with the following hypersensitivity: 1. Known hypersensitivity to any component or excipient of pirtobrutinib and venetoclax 2. Prior significant hypersensitivity to rituximab 3. Known allergy to allopurinol and inability to take uric acid lowering agent
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS per International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Criteria 2018, assessed by Independent Review Committee (IRC)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB215610 · Substance
- Active substance
- Pirtobrutinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 156800 mg milligram(s)
- Max treatment duration
- 784 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB215610 · Substance
- Active substance
- Pirtobrutinib
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 156800 mg milligram(s)
- Max treatment duration
- 784 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 3
SUB176260 · Substance
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 274190 mg milligram(s)
- Max treatment duration
- 707 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB176260 · Substance
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 274190 mg milligram(s)
- Max treatment duration
- 707 Day(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
- 500 mg/m2 milligram(s)/square meter
- Max total dose
- 2875 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Month(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
Loxo Oncology Inc.
- Sponsor organisation
- Loxo Oncology Inc.
- Address
- 281 Tresser Boulevard Floor 9th
- City
- Stamford
- Postcode
- 06901-3238
- Country
- United States
Scientific contact point
- Organisation
- Loxo Oncology Inc.
- Contact name
- Lilly Clinical Trials information desk
Public contact point
- Organisation
- Loxo Oncology Inc.
- Contact name
- Lilly Clinical Trials information desk
Third parties 9
| Organisation | City, country | Duties |
|---|---|---|
| Infinity Biologix LLC ORG-100040369
|
Piscataway, United States | Other |
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other, Laboratory analysis |
| Q Squared Solutions Limited ORG-100042527
|
Reading, United Kingdom | Laboratory analysis |
| Perceptive Eclinical Limited ORG-100041144
|
Nottingham, United Kingdom | Other |
| Unisphere Travel Ltd. Inc. ORG-100043100
|
Norwood, United States | Other |
| Eli Lilly & Co. ORG-100000156
|
Indianapolis, United States | Code 8 |
| Eresearchtechnology Inc. ORG-100013039
|
Pittsburgh, United States | Other |
| Neogenomics Inc. ORG-100044076
|
Fort Myers, United States | Other, Laboratory analysis |
| IQVIA Limited ORG-100008655
|
Reading, United Kingdom | On site monitoring, Code 12, Other, Code 2, Code 5, Data management, E-data capture |
Locations
11 EU/EEA countries · 70 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Ongoing, recruitment ended | 4 | 3 |
| Czechia | Ongoing, recruitment ended | 36 | 4 |
| Denmark | Ongoing, recruitment ended | 7 | 1 |
| France | Ongoing, recruitment ended | 48 | 15 |
| Germany | Ongoing, recruitment ended | 12 | 6 |
| Hungary | Ongoing, recruitment ended | 3 | 3 |
| Ireland | Ongoing, recruitment ended | 1 | 2 |
| Italy | Ongoing, recruitment ended | 40 | 13 |
| Poland | Ongoing, recruitment ended | 63 | 7 |
| Spain | Ongoing, recruitment ended | 38 | 14 |
| Sweden | Ongoing, recruitment ended | 10 | 2 |
| Rest of world
Russian Federation, Australia, United States, Singapore, Japan, Switzerland, Canada, Taiwan, Israel, China, United Kingdom, Korea, Republic of
|
— | 377 | — |
Investigational sites
Universitair Ziekenhuis Gent
Hematology, Corneel Heymanslaan 10, 9000, Gent
Pole Hospitalier Jolimont
Hematology, Rue Ferrer 159, 7100, La Louviere
Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Hematology, Avenue Docteur Gaston Therasse 1, 5530, Yvoir
Fakultni Nemocnice Brno
Internal hematology and oncology clinic, Jihlavska 340/20, Bohunice, Brno
Vseobecna Fakultni Nemocnice V Praze
1st Dep. of Medicine - Dep. of Hematology, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Kralovske Vinohrady
Internal Hematology Clinic, Srobarova 1150/50, Vinohrady, Prague
Fakultni Nemocnice Hradec Kralove
4th Department of Internal Medicine – Haematology, Sokolska 581, 500 03, Novy Hradec Kralove
Rigshospitalet
Hematology, Blegdamsvej 9, 2100, Copenhagen Oe
Centre Hospitalier Universitaire De Montpellier
Hématologie Option Maladies du sang, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Clinique Victor Hugo
Biologie médicale, Centre De Cancerologie De La Sarthe, 64 Rue De Degre, Le Mans
Centre Hospitalier Regional Universitaire De Tours
Hématologie, 2 Boulevard Tonnelle, 37044, Tours Cedex 9
Centre Hospitalier Lyon Sud
Hématologie option maladies du sang, 165 Chemin Du Grand Revoyet, 69310, Pierre-Benite
Assistance Publique Hopitaux De Paris
Hématologie option maladies du sang, 47 Boulevard De L Hopital, 75651, Paris Cedex 13
Centre Henri Becquerel
Hématologie, Rue D Amiens, 76038, Rouen Cedex
Hopital Saint Louis
Hématologie - Oncologie, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Poitiers
Hématologie, 2 Rue De La Miletrie, 86000, Poitiers
CHRU De Nancy
Médecine Interne, Rue Du Morvan, 54500, Vandoeuvre Les Nancy
Centre Hospitalier Universitaire De Rennes
Hématologie, 2 Rue Henri Le Guilloux, 35000, Rennes
Centre Hospitalier Universitaire De Nantes
Hématologie option oncohématologie, 1 Place Alexis Ricordeau, 44000, Nantes
Institut Universitaire Du Cancer Toulouse-Oncopole
Hématologie, 1 Avenue Irene Joliot Curie, France, Toulouse
Centre Henri Becquerel
Hématologie, Rue D Amiens, 76038, Rouen Cedex
Centre Hospitalier Et Universitaire De Limoges
Hématologie, 2 Avenue Martin Luther King, 87042, Limoges Cedex 1
Les Hopitaux Universitaires De Strasbourg
Hématologie, 1 Place De L Hopital, Cs 80426, Strasbourg Cedex
University Hospital Cologne AöR
Klinik I für innere Medizin, Kerpener Strasse 62, Lindenthal, Cologne
Rostock University Medical Center
ZIM III für Hämatologie, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Haematologisch Onkologische Schwerpunktpraxis
Gemeinschaftspraxis Dres. Schöttker & Pretscher, Schweinfurter Strasse 7, Altstadt, Wuerzburg
Muenchen Klinik gGmbH
Klinik für Hämatologie und Onkologie, Koelner Platz 1, Schwabing-West, Munich
Universitaetsklinikum Essen AöR
Klinik für Hämatologie und Stammzelltransplantation, Hufelandstrasse 55, Holsterhausen, Essen
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie, Zelltherapie und Hämostaseologie, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Haematológiai Osztály, Tallian Gyula Utca 20-32, 7400, Kaposvar
Orszagos Onkologiai Intezet
Hematológia és Lymphoma osztály "Kemoterápia A", Rath Gyorgy Utca 7-9, Kerulet, Budapest XII
University Of Debrecen
Belgyógyászati Klinika. B épület. Hematológia, Nagyerdei Korut 98, 4032, Debrecen
University Hospital Waterford
Haem, Dunmore Road, X91 ER8E, Waterford
Mater Misericordiae University Hospital
Haematology, Eccles Street, D07 R2WY, Dublin 7
Azienda ospedaliera universitaria Renato Dulbecco
Oncoematologia, Via Tommaso Campanella 115, Italy, Catanzaro
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliero Universitaria Di Modena
SC Ematologia, Largo Del Pozzo 71, 41124, Modena
Ospedale San Raffaele S.r.l.
Oncologia, Via Olgettina 60, 20132, Milan
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Divisione di Ematologia, Viale Del Policlinico 155, 00161, Rome
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Oncologia Medica, Largo Agostino Gemelli 8, 00168, Rome
Careggi University Hospital
SODc Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Hematology, Corso Bramante 88, 10126, Turin
ASST Grande Ospedale Metropolitano Niguarda
SC Ematologia, Piazza Dell'ospedale Maggiore 3, 20162, Milan
University Hospital Of Ferrara
UO Ematologia, Cona, Via Aldo Moro 8, Ferrara
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UO Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncologia medica, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliera Santa Croce E Carle
SC Ematologia, Via Michele Coppino 26, 12100, Cuneo
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematoonkologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 11, 20-081, Lublin
Pratia S.A.
NA, Ul. Pana Tadeusza 2, 30-727, Cracow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematologii z Pododdziałem Chemoterapii - Klinika Hematologii, Ul. Pabianicka 62, 93-513, Lodz
Pratia Hematologia Sp. z o.o.
N/A, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Medicover Integrated Clinical Services Sp. z o.o.
N/A, Ul. Stefana Batorego 18/22, 87-100, Torun
Szpitale Pomorskie Sp. z o.o.
Oddział Hematologii i Transplantologii Szpiku, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Hospital Universitario De Toledo
Hematologia, Avenue Del Rio Guadiana Sn, 45007, Toledo
MD Anderson Cancer Center
oncologia-hematologia, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Virgen De La Macarena
hematologia y hematoterapia, Avenida Del Doctor Fedriani 3, 41009, Sevilla
Hospital Universitari Vall D Hebron
Hematologia, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
University Hospital Virgen Del Rocio S.L.
Unidad de ensayos clinicos, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinic De Barcelona
hematologia, Calle Villarroel 170, 08036, Barcelona
Hospital Universitario Y Politecnico La Fe
Hematologia, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Central De Asturias
hematologia, Avenida De Roma S/n, 33011, Oviedo
Hospital Costa Del Sol
Hematología, Terreno Autovia Mediterraneo A-7 S/n, 29603, Marbella
Hospital Universitario Quironsalud Madrid
Hematologia, Calle De Diego De Velazquez 1, 28223, Pozuelo De Alarcon
Hospital Universitario De La Princesa
oncologia, Calle De Diego De Leon 62, 28006, Madrid
Hospital Universitario Infanta Leonor
hematologia y hematoterapia, Avenida Gran Via Del Este 80, 28031, Madrid
Hospital Universitario Fundacion Jimenez Diaz
oncology, Avenida De Los Reyes Catolicos 2, 28040, Madrid
Hospital Universitario Puerta De Hierro De Majadahonda
Hematologia, Calle De Manuel De Falla 1, 28222, Majadahonda
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 |
|---|---|---|---|---|---|
| Belgium | 2021-10-18 | 2022-03-10 | 2024-07-25 | ||
| Czechia | 2021-11-30 | 2021-12-09 | 2024-07-25 | ||
| Denmark | 2022-09-09 | 2022-09-21 | 2024-07-25 | ||
| France | 2021-10-14 | 2021-10-18 | 2024-07-25 | ||
| Germany | 2022-10-07 | 2023-01-30 | 2024-07-25 | ||
| Hungary | 2023-04-04 | 2023-04-13 | 2024-07-25 | ||
| Ireland | 2022-10-18 | 2022-11-22 | 2024-07-25 | ||
| Italy | 2021-12-22 | 2022-02-23 | 2024-07-25 | ||
| Poland | 2022-01-20 | 2022-02-15 | 2024-07-25 | ||
| Spain | 2021-11-18 | 2021-12-14 | 2024-06-24 | ||
| Sweden | 2022-09-01 | 2023-02-22 | 2024-07-25 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 134 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-507698-16_Redacted | 6.0 |
| Protocol (for publication) | D4_Patient facing documents_Copyright statement | N/A |
| Recruitment arrangements (for publication) | K_Recruitment arrangements omission justification_Hungary | 1 |
| Recruitment arrangements (for publication) | K1_2023-507698-16_Recruit Arrangement_Memo_San | 1.0 |
| Recruitment arrangements (for publication) | K1_2023-507698-16_Recruitment arrangements_Blank Placeholder_san | V1.0 |
| Recruitment arrangements (for publication) | K1_Blank doc for CTIS placeholders for transitional trial_san | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent placeholder | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent placeholder | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent placeholder | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment and Consent placeholder_san | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment and Informed consent procedure_Blank Placeholder_san | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement | 1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_Blank_page_san | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and Consent Procedures | n/a |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements and Consent Procedures | V1.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_Blank placeholder for publication | 1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Summary of Changes | V2.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Summary of Changes 2_RedSan | 2.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Summary of Changes_Red-San | 1.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-507698-16_ICF Addendum Tx Beyond PD_san | V3.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_2023-507698-16_Main ICF_red_san | V5.0FRA3.0 |
| Subject information and informed consent form (for publication) | L1_2023-507698-16_SOC Main ICF_san_red | 2.0FRA1.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_hu_redacted_san | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Add treat | V3.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum Tx Beyond PD_13Mar2023 | 3.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Addendum_Treatment Beyond Progression_Clean_nonred_san | V3.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | V5-0ESP1-0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main Adult_05May2023_redacted | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy | V1.0ESP1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Summary_hu | V1.0HUN1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Tx Beyond PD_san | V3.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum Tx Beyond_san | V3.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum TxP_en | V3.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum TxP_fr | V3.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Addendum TxP_nl | V3.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Amendment summary_red_san | v2DEUde1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_already enrolled patient_red_san | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Clean_red | V5.0SWE2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_clean_red_san | 5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_en_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_fr_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_nl_red | V5.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_redacted | V5.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_hu_redacted | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Red_san | V5.0ITA1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_red-san | V5DEUde1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_san_red | V7.0DNK1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Reimbursement and travel services-red-san | V1.0DEU5.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_san | v1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_san_red | V2.0SWE1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_san_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes ICF_TC_san | v1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V1_en_clean | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V1_fr_clean | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V1_nl_clean | V1.0BEL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V2_en_red | V2.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V2_fr_red | V2.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary of Changes Main ICF V2_nl_red | V2.0BEL2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Summary_PL_clean_redacted | V2.0POL1.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Tx Beyond PD-san | V3.0DEU3.0 |
| Subject information and informed consent form (for publication) | L1_SIS nad ICF_Main Summary of Changes ICF_san | V2.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Participant study guide_san | 03FRAfr01 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient documents_Memo_San | 1.0 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_Colpitts_Patient Brochure_san | 1 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_Colpitts_PEX Card documents | N/A |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_Colpitts_Prepaid Visa Card_FAQs_san | 1 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_ePRO Patient Information Guide_san | 03 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_Happify_Card_san | 1 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_Happify_FAQs_san | 1 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_Happify_Flyer_san | 1 |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_Patient Brochure_san | 02FRAfr |
| Subject information and informed consent form (for publication) | L2_2023-507698-16_Patient Material_Patient ID Card_san | 01FRAfr01 |
| Subject information and informed consent form (for publication) | L2_Collpitts_Patient Brochure_hu | 1.1 |
| Subject information and informed consent form (for publication) | L2_Collpitts_Prepaid Visa Card_FAQs_hu | 1 |
| Subject information and informed consent form (for publication) | L2_ePRO_HH Training Module_hu | 1.00 |
| Subject information and informed consent form (for publication) | L2_ePRO_Patient_Information_Guide_hu | V03HUNhu |
| Subject information and informed consent form (for publication) | L2_ePRO_Reminder Icon_hu | 1.00 |
| Subject information and informed consent form (for publication) | L2_ePRO_Subject Facing Custom_hu | 1 |
| Subject information and informed consent form (for publication) | L2_Happify_Card_hu | 1 |
| Subject information and informed consent form (for publication) | L2_Happify_FAQs_hu | 1 |
| Subject information and informed consent form (for publication) | L2_Happify_Flyer_hu | 1 |
| Subject information and informed consent form (for publication) | L2_ICF Mandatory Genetic_hu | 2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Card terms and conditions_blank | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information material_Colpitts prepaid Visa Card FAQ_blank | 1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Main GDPR ICF_clean_san | CZE2.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Main ICF_site specific_2202_already enrolled patient_red_san | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Main ICF_site specific_2202_clean_red_san | 5.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional ICF_already enrolled patient_red_san_ | V3.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional ICF_clean_red_san | V3.0CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional Study ICF_already enrolled patient_red_san | V4.1CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional Study ICF_clean_red_san | V4.1CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional Study II ICF_already enrolled patient_red_san | V4.1CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional Study II ICF_clean_red_san | V4.1CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional Study II ICF_site specific 2202_clean_red_san | V4.1CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Optional Study II ICF_site specific 2202_enrolled patient_red_s | V4.1CZE1.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Tx Beyond PD ICF_already enrolled patient_san | 4.1 |
| Subject information and informed consent form (for publication) | L2_Other subject information_Tx Beyond PD ICF_clean_san | 4.1 |
| Subject information and informed consent form (for publication) | L2_OtherSubInfo_BfS Information_red_san | V2 |
| Subject information and informed consent form (for publication) | L2_Participant Study Guide_hu | V05HUN(hu) |
| Subject information and informed consent form (for publication) | L2_Patient ID Card_hu | V01HUNhu01 |
| Subject information and informed consent form (for publication) | L2_PEX Card_hu | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF_Summary_cl | V1.0TA2.0 |
| Subject information and informed consent form (for publication) | L2_SIS Mandatory Genetic_hu_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L3_ICF Addendum_hu | 3.0 |
| Subject information and informed consent form (for publication) | L3_List of modified documents_hu_en_san | 1 |
| Subject information and informed consent form (for publication) | L3_SIS Addendum_hu | 3.0 |
| Subject information and informed consent form (for publication) | L3_SIS and ICF_Addendum Tx Beyond PD | V3.0ITA1.0 |
| Subject information and informed consent form (for publication) | L4_ICF Opt Gen_hu_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L4_SIS and ICF_Optional Research_cl_Red_san | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L4_SIS Opt Gen_hu_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L5_ICF PP_hu | 2.0 |
| Subject information and informed consent form (for publication) | L5_SIS and ICF_Future Unspecified Research_cl_Red_san | V1.0ITA2.0 |
| Subject information and informed consent form (for publication) | L5_SIS PP_hu_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L6_List of submitted documents_en | 1 |
| Subject information and informed consent form (for publication) | L6_List of submitted documents_hu | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_MabThera_Rituximab_30Nov2023 | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Venclyxto_venetoclax | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_BE-de_2023-507698-16_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_BE-fr_2023-507698-16_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_BE-nl_2023-507698-16_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_CZ_2023-507698-16_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_EN_2023-507698-16_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_ES_2023-507698-16_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_FR_2023-507698-16_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_HU_2023-507698-16_Redacted | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_IT_2023-507698-16_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_PL_2023-507698-16_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Lay Summary_SE_2023-507698-16_Redacted | 1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2023-507698-16_redacted | 2.0CZE1.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ES_2023-507698-16_redacted | 6.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_HU_2023-507698-16_redacted | 5.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_SE_2023-507698-16-00_redacted | 6.0 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-14 | Hungary | Acceptable 2024-06-12
|
2024-06-12 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-09-30 | Hungary | Acceptable 2025-01-13
|
2025-01-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-14 | Hungary | Acceptable 2025-08-01
|
2025-08-01 |
| 4 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-08-18 | Hungary | Acceptable 2025-08-01
|
2025-08-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-10-14 | Hungary | Acceptable 2026-02-02
|
2026-02-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-6 | 2026-03-10 | Acceptable | 2026-04-14 |