Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
249
Countries
5
Sites
33
Chronic lymphotic leukemia and Small Lymphocytic lymphoma
To evaluate the efficacy of BGB-16673 compared to investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment, as measured by progression-free survival (PFS) determined by independent review committee (IRC)
Key facts
- Sponsor
- BeOne Medicines AG
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 29 Jul 2025 → ongoing
- Decision date (initial)
- 2025-06-17
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To evaluate the efficacy of BGB-16673 compared to investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment, as measured by progression-free survival (PFS) determined by independent review committee (IRC)
Secondary objectives 5
- To evaluate the efficacy of BGB-16673 compared to investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment, as measured by overall survival (OS)
- To evaluate the efficacy of BGB-16673 compared to investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment among patients who received noncovalent BTK inhibitors (ncBTKi), as measured by PFS determined by IRC
- To further compare efficacy of BGB-16673 and investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment, as measured by additional efficacy endpoints
- To compare the safety of BGB-16673 versus investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment
- To compare patient-reported disease-specific symptoms and functioning in patients receiving BGB-16673 versus investigator’s choice of idelalisib plus rituximab or bendamustine plus rituximab or venetoclax plus rituximab retreatment
Conditions and MedDRA coding
Chronic lymphotic leukemia and Small Lymphocytic lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10008976 | Chronic lymphocytic leukemia | 10029104 |
| 21.0 | LLT | 10051812 | Small cell lymphocytic lymphoma | 10029104 |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration, European Medicines Agency
- Plan to share IPD
- Yes
- IPD plan description
- BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, and shared when it is feasible to do so without compromising the privacy of study participants. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data along with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Confirmed diagnosis of CLL or SLL, requiring treatment, based on 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria.
- Previously received treatment for CLL/SLL with both a BTKi and a BCL2i.
- Participants with SLL must have measurable disease by computer tomography (CT)/magnetic resonance imaging (MRI)
- Eastern Cooperative Oncology Group (ECOG) score 0, 1 or 2
- Adequate liver function
- Adequate blood clotting function
Exclusion criteria 6
- Known prolymphocytic leukemia or history of, or currently suspected, Richter’s transformation
- Prior autologous stem cell transplant or chimeric antigen receptor-T cell therapy in the last 3 months
- Known central nervous system involvement
- Prior exposure to any BTK protein degraders
- Active fungal, bacterial and/or viral infection requiring parenteral systemic therapy
- Clinically significant cardiovascular disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS, defined as time from the date of randomization to the date of first disease progression or death, whichever occurs first, as determined by IRC using modified 2018 International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria for patients with chronic lymphocytic leukemia (CLL) and Lugano classification for patients with small lymphocytic lymphoma (SLL).
Secondary endpoints 9
- OS, defined as time from the date of randomization to the date of death due to any cause
- PFS in patients who were exposed to ncBTKi, determined by IRC
- PFS determined by investigator assessment
- Overall response rate (partial response [PR] or better) determined by IRC and by investigator assessment, per modified 2018 iwCLL criteria for patients with CLL and Lugano classification for patients with SLL
- Rate of PR with lymphocytosis or higher determined by IRC and by investigator assessment
- Duration of response determined by IRC and by investigator assessment
- Time to next anti-CLL/SLL treatment (TTNT)
- Incidence and severity of treatment-emergent adverse events (TEAEs), serious TEAEs, and laboratory abnormalities graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0
- Patient-reported symptom burden and physical condition/fatigue measured by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnairechronic lymphocytic leukemia module 17 items (QLQ-CLL17) and global health status (GHS) and physical functioning measured by EORTC quality of life questionnaire core 30 (QLQ-C30)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
PRD10290214 · Product
- Active substance
- BGB-16673
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 288 g gram(s)
- Max treatment duration
- 58 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
PRD10290213 · Product
- Active substance
- BGB-16673
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 288 g gram(s)
- Max treatment duration
- 58 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- BEIGENE
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 8
Zydelig 150 mg film-coated tablets
PRD1682822 · Product
- Active substance
- Idelalisib
- Substance synonyms
- GS-1101
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 315 g gram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EM01 — -
- Marketing authorisation
- EU/1/14/938/002
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Zydelig 100 mg film-coated tablets
PRD1682821 · Product
- Active substance
- Idelalisib
- Substance synonyms
- GS-1101
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 300 mg milligram(s)
- Max total dose
- 315 g gram(s)
- Max treatment duration
- 36 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EM01 — -
- Marketing authorisation
- EU/1/14/938/001
- MA holder
- GILEAD SCIENCES IRELAND UNLIMITED COMPANY
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Levact 2,5 mg/ml poudre pour solution à diluer pour perfusion
PRD10254820 · Product
- Active substance
- Bendamustine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 70 mg/m2 milligram(s)/sq. meter
- Max total dose
- 840 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AA09 — -
- Marketing authorisation
- 1665/11010151
- MA holder
- PHARMAAND GMBH
- MA country
- Luxembourg
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Venclyxto 50 mg film-coated tablets
PRD6353826 · Product
- Active substance
- Venetoclax
- Substance synonyms
- ABT-199, GDC-0199, 4-(4-((2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL)METHYL)PIPERAZIN-1-YL)-N-((3-NITRO-4-((TETRAHYDRO-2H-PYRAN-4-YLMETHYL)AMINO)PHENYL)SULFONYL)-2-(1H-PYRROLO(2,3-B)PYRIDIN-5-YLOXY)BENZAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 297390 mg milligram(s)
- Max treatment duration
- 109 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/003
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Venclyxto 100 mg film-coated tablets
PRD11643495 · Product
- Active substance
- Venetoclax
- Substance synonyms
- ABT-199, GDC-0199, 4-(4-((2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL)METHYL)PIPERAZIN-1-YL)-N-((3-NITRO-4-((TETRAHYDRO-2H-PYRAN-4-YLMETHYL)AMINO)PHENYL)SULFONYL)-2-(1H-PYRROLO(2,3-B)PYRIDIN-5-YLOXY)BENZAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 297390 mg milligram(s)
- Max treatment duration
- 109 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/008
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Venclyxto 10 mg film-coated tablets
PRD6353818 · Product
- Active substance
- Venetoclax
- Substance synonyms
- ABT-199, GDC-0199, 4-(4-((2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL)METHYL)PIPERAZIN-1-YL)-N-((3-NITRO-4-((TETRAHYDRO-2H-PYRAN-4-YLMETHYL)AMINO)PHENYL)SULFONYL)-2-(1H-PYRROLO(2,3-B)PYRIDIN-5-YLOXY)BENZAMIDE
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 297390 mg milligram(s)
- Max treatment duration
- 109 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/001
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MabThera 500 mg concentrate for solution for infusion
PRD2154043 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2867 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/98/067/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
MabThera 100 mg concentrate for solution for infusion
PRD2159285 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- SOLUTION FOR INFUSION
- Max daily dose
- 500 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2875 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/98/067/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
BeOne Medicines AG
- Sponsor organisation
- BeOne Medicines AG
- Address
- Aeschengraben 27
- City
- Basel
- Postcode
- 4051
- Country
- Switzerland
Scientific contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Public contact point
- Organisation
- BeOne Medicines AG
- Contact name
- BeOne Medical Officer
Third parties 20
| Organisation | City, country | Duties |
|---|---|---|
| Laboratory Corporation Of America Holdings ORG-100041800
|
Torrance, United States | Laboratory analysis |
| PPD Development LP ORG-100011560
|
Richmond, United States | Laboratory analysis |
| Burning Rock Dx LLC ORG-100048295
|
Irvine, United States | Other |
| Clinchoice Medical (Tianjin) Co. Ltd. ORG-100053189
|
Tianjin, China | Other |
| PPD Development LP ORG-100011560
|
Richmond, United States | Other |
| Iqvia Laboratories Limited ORG-100042527
|
Livingston, United Kingdom | Laboratory analysis |
| Scout Clinical ORG-100042228
|
Dallas, United States | Other |
| MLL Dx GmbH ORG-100046368
|
Munich, Germany | Laboratory analysis |
| Wuxi Apptec Co. Ltd. ORG-100012470
|
Shanghai, China | Laboratory analysis |
| Labcorp Pharmaceutical Research And Development (Shanghai) Co. Ltd. ORG-100043119
|
Shanghai, China | Laboratory analysis |
| Icon Clinical Research Limited ORG-100008322
|
Dublin 18, Ireland | Code 12 |
| Universitaetsklinikum Ulm AöR ORG-100006370
|
Ulm, Germany | Laboratory analysis |
| PPD (UK) Limited ORG-100022673
|
Cambridge, United Kingdom | Other |
| Adaptive Biotechnologies Corp. ORG-100044428
|
Seattle, United States | Laboratory analysis |
| Predicine Inc. ORG-100043724
|
Hayward, United States | Laboratory analysis |
| Almac Clinical Technologies LLC ORG-100043036
|
Souderton, United States | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Laboratory analysis |
| Perceptive Informatics Inc. ORG-100013171
|
Burlington, United States | Other |
| Datacubed Health Inc. ORG-100047227
|
King Of Prussia, United States | Other |
| Medidata Solutions Inc. ORG-100016256
|
New York, United States | E-data capture |
Locations
5 EU/EEA countries · 33 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruiting | 7 | 4 |
| Germany | Ongoing, recruiting | 13 | 12 |
| Italy | Ongoing, recruiting | 14 | 9 |
| Netherlands | Ongoing, recruiting | 4 | 2 |
| Poland | Ongoing, recruiting | 19 | 6 |
| Rest of world
United States, Mexico, Brazil, Japan, Turkey, Australia, United Kingdom, Canada, China, Argentina, New Zealand, Korea, Republic of
|
— | 192 | — |
Investigational sites
Fakultni Nemocnice Ostrava
Department of Hematooncology, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Brno
Interní hematologická a onkologická klinka, Jihlavska 340/20, Bohunice, Brno
Vseobecna Fakultni Nemocnice V Praze
HematoOnco, U Nemocnice 499/2, Nove Mesto, Prague
Fakultni Nemocnice Hradec Kralove
IV. interní hematologická klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Centrum für Hämatologie und Onkologie Bethanien
NA, Im Prüfling 17-19, 60389, Frankfurt
Institut Fuer Versorgungsforschung In Der Onkologie GbR
NA, Neversstrasse 5, Sued, Koblenz
Universitaet Leipzig
Klinik und Poliklinik für Hämatologie,Zelltherapie,Hämostaseologie,Infek, Liebigstrasse 22, Zentrum-Suedost, Leipzig
Universitaetsklinikum Heidelberg AöR
Internal Medicine V: Hematology, Oncology und Rheumatology, Im Neuenheimer Feld 410, Neuenheim, Heidelberg
Universitaetsklinikum Muenster AöR
Medizinische Klinik A, Albert-Schweitzer-Campus 1, Sentrup, Muenster
Universitaetsklinikum Augsburg
II. Medizinische Klinik, Stenglinstrasse 2, Kriegshaber, Augsburg
Medical Center - University Of Freiburg
Clinic for Internal Medicine I, Hematology, Oncology and Stem Cell Transplantation, Hugstetter Strasse 55, Stuehlinger, Freiburg Im Breisgau
Praxis am Volkspark
NA, Bundesallee 55, 10715, Berlin
University Medical Center Hamburg-Eppendorf
II. Medizinische Klinik und Poliklinik, Martinistrasse 52, Eppendorf, Hamburg
Universitaet Des Saarlandes
Clinic of Internal Medicine I, Kirrberger Strasse 100, 66421, Homburg
Universitaetsklinikum Essen AöR
Clinic for Hematology and Stern Cell Transplantation, Hufelandstrasse 55, Holsterhausen, Essen
Klinikum Chemnitz gGmbH
Internal Medicine III, Flemmingstrasse 2, Altendorf, Chemnitz
Azienda Ospedaliero Universitaria Careggi
SOD Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Ematologia e Trapianto di cellule staminali emopoietiche, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliera Di Perugia
Centro Ricerche Emato-oncologiche, Piazzale Giorgio Menghini 9, 06129, Perugia
Azienda Ospedaliera Universitaria Federico II Di Napoli
U.O.C. Ematologia e Trapianti di Midollo, Via Sergio Pansini 5, 80131, Naples
Ospedale San Raffaele S.r.l.
Strategic Research Program on CLL Department, Via Olgettina 60, 20132, Milan
Fondazione IRCCS Policlinico San Matteo
Ematologia, Viale Camillo Golgi 19, 27100, Pavia
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
S.C. Ematologia, Via Francesco Sforza 35, 20122, Milan
Azienda Ospedaliero-Universitaria Maggiore Della Carita
SCDU Ematologia, Corso Giuseppe Mazzini 18, 28100, Novara
Istituto Tumori Bari Giovanni Paolo II
U.O. Ematologia e terapia cellulare, Viale Orazio Flacco 65, 70124, Bari
Radboud universitair medisch centrum Stichting
Hematology, Geert Grooteplein Zuid 10, 6525 GA, Nijmegen
Amsterdam UMC Stichting
Hematology, De Boelelaan 1117, 1081 HV, Amsterdam
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Oddział Hematologii Onkologicznej z Pododdziałem Transplantologii Klinicznej, Ul. Ks. Jozefa Bielawskiego 18, 36-200, Brzozow
Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
Oddział Wieloprofilowy Zachowawczy, Ul. Dra Kazimierza Jaczewskiego 8, 20-090, Lublin
Pratia S.A.
PRATIA MCM Kraków, Ul. Pana Tadeusza 2, 30-727, Cracow
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematologii Ogólnej i Chorób Wewnętrznych, Ul. Pabianicka 62, 93-513, Lodz
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Czechia | 2026-03-23 | 2026-03-23 | |||
| Germany | 2025-11-20 | 2025-11-20 | |||
| Italy | 2025-07-29 | 2025-07-29 | |||
| Netherlands | 2026-04-13 | 2026-04-13 | |||
| Poland | 2025-08-19 | 2025-08-19 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 94 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518893-15-00 Redacted | 3.0 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EORTC QLQ-C30_CZ | 3 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EORTC QLQ-C30_IT | 3 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EORTC QLQ-C30_ND | 3 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EORTC QLQ-CLL17_CZ | N/A |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EORTC QLQ-CLL17_IT | N/A |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EORTC QLQ-CLL17_ND | N/A |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EQ-5D-5L_CZ | 1.2 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EQ-5D-5L_IT | 1.1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_EQ-5D-5L_ND | 1.1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_PGI S CLL_SLL_CZ | 4 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_PGI-S CLL_SLL_IT | 4 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_PRO-CTCAE_CZ | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_PRO-CTCAE_IT | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Paper_PRO-CTCAE_ND | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-C30_CZ | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-C30_DE | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-C30_IT | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-C30_ND | 0.2 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-C30_PL | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-CLL17_CZ | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-CLL17_DE | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-CLL17_IT | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-CLL17_ND | 0.2 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EORTC QLQ-CLL17_PL | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EQ-5D-5L_CZ | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EQ-5D-5L_DE | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EQ-5D-5L_IT | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EQ-5D-5L_ND | 0.2 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_EQ-5D-5L_PL | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_PGI-S CLL_SLL_DE | 2 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_PGI-S CLL_SLL_PL | 2 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_PRO-CTCAE_CZ | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_PRO-CTCAE_DE | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_PRO-CTCAE_IT | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_PRO-CTCAE_ND | 0.2 |
| Protocol (for publication) | D4_Patient facing Questionnaire -Tablet_PRO-CTCAE_PL | 1 |
| Protocol (for publication) | D4_Patient facing Questionnaire-Paper_PGI S CLL_SLL_ND | 4 |
| Protocol (for publication) | D4_Patient facing Questionnaire-Tablet_PGI S CLL_SLL_CZ | 2 |
| Protocol (for publication) | D4_Patient facing Questionnaire-Tablet_PGI S CLL_SLL_ND | 2 |
| Protocol (for publication) | D4_Patient facing Questionnaire-Tablet_PGI-S CLL_SLL_IT | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF process | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF process_TC | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and ICF process_Track changes | NA |
| Recruitment arrangements (for publication) | K1_Recruitment and informed consent procedure | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 2.0 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | v1.1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_clean | 2.0 |
| Subject information and informed consent form (for publication) | L_SIS and ICF Pregnancy_NL | V2.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Attachment to Main ICF Study Procedures | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Attachment to Main ICF_procedures_highlighted ICF_already screened subjects | 3 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main_ clean highlighted ICF_already screened subjects_redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Main_redacted | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnant Partner_ Clean highlighted ICF_already screened subjects | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Privacy and Data Protection | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Privacy and Data Protection_Clean highlighted ICF_already screened subjects | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Scout_Clean redacted_highlighted ICF_already screened subjects | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Storage and Future Research | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Storage and Future Research_ Clean highlighted ICF_already screened subjects | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Treatment Through Progression | 2 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Treatment Through Progression_Clean highlighted ICF_already screened subjects | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF For Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_NL_Redacted | V2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Storage and Future Research with Biological Samples | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Scout_redacted | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment through progression | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Treatment Through Progression_NL | V2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_ Pregnant Partner | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Discontinuation | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future Research_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main ICF_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnant Partner ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Privacy & Data Processing ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Through Progression | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Treatment Through Progression ICF | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and Main ICF _Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L2_GP Letter | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Diary_Arm_A_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_Patient Diary_Arm_B_Ide-Rit | 1.0 |
| Subject information and informed consent form (for publication) | L2_Patient Diary_Arm_B_Ven-Rit | 3 |
| Subject information and informed consent form (for publication) | L2_Patient ID Card | 2 |
| Subject information and informed consent form (for publication) | L2_Scout - Study Brochure | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bendamustine | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Idelalisib | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rituximab | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Venetoclax | NA |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis_2024-518893-15-00_DUT_for publication | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ 2024-518893-15-00_PL_for publication | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-518893-15-00_CZE_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-518893-15-00_DE_Redacted | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_2024-518893-15-00_IT_ for publication | 3 |
Application history
12 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-02-21 | Italy | Acceptable 2025-06-16
|
2025-06-17 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-07-21 | Italy | Acceptable 2025-06-16
|
2025-07-21 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-07-22 | Acceptable 2025-06-16
|
2025-07-22 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-08-12 | Italy | Acceptable | 2025-09-09 |
| 5 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-08-13 | Acceptable | 2025-09-11 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-21 | Acceptable | 2025-09-11 | |
| 7 | SUBSEQUENT ADDITION OF MSC | APP-7 | 2025-08-28 | Acceptable 2025-06-16
|
2025-11-17 | |
| 8 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-11-19 | Italy | Acceptable 2025-06-16
|
2025-11-19 |
| 9 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-11-26 | Acceptable 2025-06-16
|
2025-11-26 | |
| 10 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-26 | Italy | Acceptable 2025-12-12
|
2025-12-12 |
| 11 | NON SUBSTANTIAL MODIFICATION | NSM-5 | 2026-01-14 | Italy | Acceptable 2025-12-12
|
2026-01-14 |
| 12 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-02-10 | Italy | Acceptable 2026-05-15
|
2026-05-18 |