Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
758
Countries
5
Sites
15
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
To assess whether MRD-driven finite AV treatment is NI to MRD-driven finite VO treatment with respect to PFS
Key facts
- Sponsor
- Astrazeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 28 Oct 2022 → ongoing
- Decision date (initial)
- 2024-03-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-505866-27-00
- EudraCT number
- 2021-003936-10
- ClinicalTrials.gov
- NCT05057494
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Efficacy, Safety
To assess whether MRD-driven finite AV treatment is NI to MRD-driven finite VO treatment with respect to PFS
Secondary objectives 5
- To assess the effect of AV treatment compared with VO treatment on uMRD at sequential timepoints
- To assess the effect of AV treatment compared with VO treatment on OS
- To assess the effect of AV treatment compared with VO treatment on EFS
- To assess the effect of AV treatment compared with VO treatment on ORR
- To assess symptoms, functional status, global health status/QoL, and patient perceived benefit-risk in participants treated with AV versus VO using the EORTC QLQ-C30, EORTC QLQC-LL17, NCI PRO-CTCAE item for Bruising, and PGI-BR
Conditions and MedDRA coding
Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | PT | 10008958 | Chronic lymphocytic leukaemia | 100000004864 |
| 21.1 | PT | 10003908 | B-cell small lymphocytic lymphoma | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Participant must be ≥ 18 years at the time of signing the consent form
- Documented TN CLL/SLL requiring treatment according to iwCLL guidelines 2018 (Hallek et al 2018) including a detectable clonal B-cell population at baseline for purposes of measuring for MRD
- Adequate BM function independent of growth factor or platelet transfusion support within 2 weeks of screening initiation as follows: (a) Absolute neutrophil count ≥ 1.0 × 10^9/L; absolute neutrophil count ≥ 500 cells/μL (≥ 0.50 × 10^9/L) with documented BM involvement of CLL/SLL (b) Platelet counts ≥ 30 × 10^9/L; platelet count ≥ 10 × 10^9/L in participants with documented BM involvement of CLL/SLL
- Estimated CrCL of ≥ 30 mL/min, calculated by Cockcroft-Gault (using actual body weight), or serum creatinine < 2 × ULN: Males: CrCL (mL/min) = Weight (kg) × (140 - Age) / 72 × serum creatinine (mg/dL) Females: CrCL (mL/min) = Weight (kg) × (140 - Age) × 0.85 / 72 × serum creatinine (mg/dL)
- Meet the following laboratory parameters (ULN is based on institutional standards): (a) Serum AST and ALT ≤ 3 × ULN (Higher thresholds may be allowed if hepatic dysfunction is attributable to CLL/SLL and after discussion with the Sponsor Hematology Safety Knowledge Group). (b) Total bilirubin ≤ 1.5 × ULN, unless directly attributable to Gilbert's syndrome
- An ECOG performance status of 0 to 2 with no deterioration over the previous 2 weeks prior to baseline or day of first dosing
Exclusion criteria 14
- As judged by the investigator, any evidence of past or current diseases that, in the investigator's opinion, makes it undesirable for the participant to participate in the study or that would jeopardize their safety or compliance with the protocol or would put the study at risk
- Clinically significant cardiovascular disease, such as symptomatic arrhythmias, congestive heart failure, or myocardial infarction, within 6 months of screening or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification
- Active bleeding or history of bleeding diathesis (eg, hemophilia or von Willebrand disease)
- Uncontrolled autoimmune hemolytic anemia or idiopathic thrombocytopenic purpura
- History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study intervention
- Child-Pugh B/C liver cirrhosis
- History of prior or current malignancy (including but not limited to known central nervous system involvement such as by CLL/SLL, leptomeningeal disease, or spinal cord compression, known prolymphocytic leukemia or history of, or currently suspected, Richter's syndrome) that could affect compliance with the protocol or interpretation of results. Possible examples where compliance or data interpretation may not be affected could include the following, per physician discretion. (a) Curatively treated BCC or SCC of the skin or carcinoma in situ of the cervix or carcinoma in situ of the prostate at any time prior to study. (b) Other cancers that have been curatively treated from which the participant is disease-free for ≥ 3 years without further treatment
- Any prior CLL/SLL-specific therapies, except prior rituximab if used for autoimmune cytopenias and not as anti-CLL/SLL treatment
- Corticosteroid use > 20 mg within 1 week before the first dose of study intervention, except as indicated for other medical conditions, such as autoimmune cytopenias, inhaled steroid for asthma, topical steroid use, or as premedication for administration of study intervention or contrast
- Requires treatment with a strong cytochrome CYP3A4 inhibitor/inducer. The use of strong CYP3A inhibitors within 1 week or strong CYP3A inducers within 3 weeks of the first dose of study drug is prohibited
- Concurrent participation in another therapeutic clinical trial. Use of investigational agents that interfere with the study intervention(s) within 30 days or 5 half-lives (whichever is longer) prior to registration for study screening
- Prothrombin time/INR or activated partial thromboplastin time, in the absence of lupus anticoagulant or attributed to anticoagulant (eg, direct oral anticoagulant) > 2 × ULN
- Currently pregnant (confirmed with positive pregnancy test) or breast feeding
- WOCBP unless the following criteria are met: a negative pregnancy test at least 30 days before start of study intervention, followed by immediate highly effective contraception; further pregnancy testing will be performed every cycle and as clinically indicated.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- PFS, defined as the time from the date of randomization until date of objective progressive disease per iwCLL 2018 criteria as assessed by the investigator or death from any cause in the absence of progression
Secondary endpoints 8
- Rate of peripheral blood uMRD
- Overall survival
- Event-free survival
- Overall response rate
- CR rate after completion of 12 cycles of venetoclax
- Change from baseline in EORTC QLQ-C30, EORTC QLQ-CLL17 scales
- Proportion of participants experiencing bruising
- Proportion of participants reporting each response option of the PGI-BR
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
Calquence 100 mg hard capsules
PRD8485701 · Product
- Active substance
- Acalabrutinib
- Substance synonyms
- ACP-196, (S)-4-(8-AMINO-3-(1-BUT-2-YNOYLPYRROLIDIN-2-YL)-IMIDAZO[1,5-Α]PYRAZIN-1-YL)-N-(PYRIDIN-2-YL)-BENZAMIDE
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 134.4 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EL02 — -
- Marketing authorisation
- EU/1/20/1479/001
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The supplied acalabrutinib IMP for this clinical trial differs from the marketed product in that it is supplied in HDPE bottles and can use printed or unprinted capsules (the marketed product (Calquence) is packed in blisters as printed capsules)
Calquence 100 mg hard capsules
PRD8485702 · Product
- Active substance
- Acalabrutinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 134.4 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EL02 — -
- Marketing authorisation
- EU/1/20/1479/002
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The supplied acalabrutinib IMP for this clinical trial differs from the marketed product in that it is supplied in HDPE bottles and can use printed or unprinted capsules (the marketed product (Calquence) is packed in blisters as printed capsules)
Calquence 100 mg film-coated tablets
PRD10242588 · Product
- Active substance
- Acalabrutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 134.4 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EL02 — -
- Marketing authorisation
- EU/1/20/1479/004
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical supply is provided in HDPE bottles (rather than blisters in MAA) and has different manufacturing sites for this clinical supply chain
Calquence 100 mg film-coated tablets
PRD10242587 · Product
- Active substance
- Acalabrutinib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 134.4 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EL02 — -
- Marketing authorisation
- EU/1/20/1479/003
- MA holder
- ASTRAZENECA AB
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- The clinical supply is provided in HDPE bottles (rather than blisters in MAA) and has different manufacturing sites for this clinical supply chain
Comparator 8
Gazyvaro 1,000 mg concentrate for solution for infusion.
PRD1753415 · Product
- Active substance
- Obinutuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 8000 mg milligram(s)
- Max treatment duration
- 24 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC15 — -
- Marketing authorisation
- EU/1/14/937/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/12/1054
- Modified vs. Marketing Authorisation
- No
Venclyxto 10 mg film-coated tablets
PRD6353822 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 251.79 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/002
- 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
PRD6353834 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 251.79 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/005
- 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
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 251.79 g gram(s)
- Max treatment duration
- 96 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
Venclyxto 100 mg film-coated tablets
PRD6353842 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 251.79 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/007
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Venclyxto 50 mg film-coated tablets
PRD6353826 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 251.79 g gram(s)
- Max treatment duration
- 96 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 50 mg film-coated tablets
PRD6353830 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 251.79 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/004
- 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
PRD6353838 · Product
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 251.79 g gram(s)
- Max treatment duration
- 96 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — -
- Marketing authorisation
- EU/1/16/1138/006
- MA holder
- ABBVIE DEUTSCHLAND GMBH & CO. KG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Parexel International Corp. ORG-100007310
|
Auburndale, United States | On site monitoring, Code 10, Code 11, Code 12, Other, Code 2, Code 5, Data management, E-data capture, Code 8, Code 9 |
Locations
5 EU/EEA countries · 15 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Ongoing, recruitment ended | 100 | 3 |
| France | Ongoing, recruitment ended | 67 | 2 |
| Hungary | Ongoing, recruitment ended | 51 | 2 |
| Poland | Ongoing, recruitment ended | 142 | 6 |
| Spain | Ongoing, recruitment ended | 27 | 2 |
| Rest of world
Australia, United States
|
— | 371 | — |
Investigational sites
Fakultni Nemocnice Ostrava
1903: Klinika hematoonkologie, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Hradec Kralove
1901: IV. interni hematologicka klinika, Sokolska 581, 500 03, Novy Hradec Kralove
Fakultni Nemocnice Plzen
1904: Hematologicko-onkologicke odd., Alej Svobody 923/80, 323 00, Plzen 23
Centre Hospitalier Regional Universitaire De Tours
2301: Hématologie et Thérapie Cellulaire, 2 Boulevard Tonnelle, 37000, Tours
Centre Hospitalier Universitaire De Montpellier
2302: Hématologie clinique, 80 Avenue Augustin Fliche, 34295, Montpellier Cedex 5
Del-Pesti Centrumkorhaz Orszagos Hematologiai Es Infektologiai Intezet
3302: Hematológiai és Őssejt- transzplantációs Osztály, Albert Florian Ut 5-7, 1097, Budapest IX
University Of Debrecen
3301: Haematológiai Tanszék, Nagyerdei Korut 98, 4032, Debrecen
Pratia S.A.
5706: Hematologia, Ul. Pana Tadeusza 2, 30-727, Cracow
Pratia Hematologia Sp. z o.o.
5702: Hematologia, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
5701: Oddz. Chemioterapii Nowotworow z Pododdzialem Chemioterapii Jednego Dnia, Ul. Pabianicka 62, 93-513, Lodz
Copernicus Podmiot Leczniczy Sp. z o.o.
5704: Oddzial Onkologii Klinicznej / Chemioterapii, Al. Zwyciestwa 31/32, 80-219, Gdansk
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie
5707: Centrum Innowacyjnych Terapii, Ul. Dr. K. Jaczewskiego 8, 20-954, Lublin
In Vivo Sp. z o.o.
5705: Hematology, Ul. Kaszubska 17h, 85-048, Bydgoszcz
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 | 2022-11-07 | 2022-11-14 | 2024-02-06 | ||
| France | 2023-02-06 | 2023-04-11 | 2024-01-03 | ||
| Hungary | 2022-12-05 | 2023-01-30 | 2024-02-13 | ||
| Poland | 2022-11-04 | 2022-11-09 | 2024-02-13 | ||
| Spain | 2022-10-28 | 2022-11-10 | 2024-02-02 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 39 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol English D8220C00027 Public | 3.0 |
| Protocol (for publication) | D4_Subject Questionnaire Transparency Placeholder D8220C00027 Public | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote D8220C00027 | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote_D8220C00027_Public | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote_D8220C00027_Public | NA |
| Recruitment arrangements (for publication) | K1_IRB-IEC Filenote_D8220C00027_Public | NA |
| Recruitment arrangements (for publication) | K1_Recruitmnet arrangemets_Placeholder D8220C00027 | NA |
| Subject information and informed consent form (for publication) | L1_HUN Subject Materials Other Dosing Card A_D8220C00027_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_HUN Subject Materials Other Dosing Card B_D8220C00027_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Adult Pregnant Medical Release Form_2023-505866-27_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Data Protection Adult_2023-505866-27_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Future Research Adult Information Sheet_D8220C00027_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Future Research Adult_D8220C00027_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Future Research Optional Labs_D8220C00027_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult for already enrolled patients_2023-505866-27_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult Patient Information Sheet_D8220C00027_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult_2023-505866-27_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main Adult_D8220C00027_Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_D8220C00027_Public | 5.1 |
| Subject information and informed consent form (for publication) | L1_ICF Main_D8220C00027_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Main_D8220C00027_Public | 5.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other_PP_D8220C00027_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Other_Pregnant Partner_D8220C00027_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner Information Sheet_D8220C00027_Public | 2.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_D8220C00027_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_D8220C00027_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_ICF Research Adult for already enrolled patients_2023-505866-27_Public | 4.0 |
| Subject information and informed consent form (for publication) | L1_ICF Research Adult_2023-505866-27_Public | 3.0 |
| Subject information and informed consent form (for publication) | L1_Subject Participation Card Arm A_D8220C00027_Public | 1.0 |
| Subject information and informed consent form (for publication) | L1_Subject Participation Card Arm B_D8220C00027_Public | 1.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Calquence tablets Public | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Gazyvaro | NA |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Venclyxto | NA |
| Synopsis of the protocol (for publication) | D1_CZE Lay Protocol Synopsis Main Czech D8220C00027 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_ESP Lay Protocol Synopsis Main Spanish D8220C00027 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_FRA Lay Protocol Synopsis Main French D8220C00027 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_HUN Lay Protocol Synopsis Main Hungarian D8220C00027 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_Lay Protocol Synopsis Main English D8220C00027 Public | 1.0 |
| Synopsis of the protocol (for publication) | D1_POL Lay Protocol Synopsis Main Polish D8220C00027 Public | 1.0 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-15 | Spain | Acceptable 2024-03-15
|
2024-03-15 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-10-31 | Spain | Acceptable 2025-02-24
|
2025-02-24 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-06-13 | Acceptable | 2025-07-24 | |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-15 | Acceptable | 2025-10-21 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-11-24 | Spain | Acceptable 2026-02-06
|
2026-02-09 |