Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
150
Countries
5
Sites
17
Newly Diagnosed Advanced Stage Follicular Lymphoma
To evaluate the Complete Metabolic Response (CMR). This means that at the end of the treatment, the person's body shows no signs of the cancer when we do tests.
Key facts
- Sponsor
- Celgene Corp.
- 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
- 10 Oct 2024 → ongoing
- Decision date (initial)
- 2024-09-25
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Celgene Corporation
External identifiers
- EU CT number
- 2024-511304-16-00
- WHO UTN
- U1111-1303-4594
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic, Safety, Pharmacodynamic
To evaluate the Complete Metabolic Response (CMR). This means that at the end of the treatment, the person's body shows no signs of the cancer when we do tests.
Secondary objectives 6
- To evaluate the safety of the combination of Golcadomide at the two doses level with rituximab.
- To determine the best dose of the combination to use in a larger study.
- To evaluate the response to treatment overall and how long responses last.
- To evaluate Progression-Free Survival (PFS), this is the amount of time from when the study starts until the cancer gets worse or the person passes away, whichever happens first.
- To evaluate the efficacy of Golcadomide in combination with rituximab regarding the Overall Survival (OS). This is the amount of time from when the study starts until the person passes away.
- To evaluate the efficacy of rituximab plus chemotherapy in participants with newly diagnosed advanced stage FL regarding CMR and how long responses last.
Conditions and MedDRA coding
Newly Diagnosed Advanced Stage Follicular Lymphoma
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 27.0 | PT | 10085127 | Follicular lymphoma stage III | 100000004864 |
| 27.0 | PT | 10085126 | Follicular lymphoma stage IV | 100000004864 |
| 27.0 | PT | 10085125 | Follicular lymphoma stage II | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 2
- Participants over the age of 18
- Participants meeting all inclusion criteria regarding disease characteristics, laboratory values and reproductive capacity status would be considered eligible.
Exclusion criteria 3
- Medical conditions or physical and laboratory test results incompatible with participation in the trial, such as significant medical disease, active infection, laboratory abnormality, incapacitating psychiatric illness
- Other lymphoma subtypes
- Specific allergies or adverse reactions to certain types of medication
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- To evaluate if the patient´s condition improves using CMR. This means that at different times during the treatment, such as 6 months or 12 months after the start of treatment, the person's disease has completely responded to the treatment.
Secondary endpoints 6
- To evaluate any negative side effects or adverse events (AE), which means an occurrence that has a negative impact on the health or well-being of a participant. This includes any new side effects that start after the treatment begins, which we call "Treatment-Emergent Adverse Events" (TEAEs).
- To evaluate all AE, including TEAE and laboratory test as well as CMR data collected during the treatment of the Golcadomide and rituximab combination.
- To evaluate the overall response rate (ORR), the percentage of participants whose cancer shrinks or disappears.
- To evaluate PFS, the time from when we start the treatment until the disease gets worse or the patient passes away.
- To evaluate OS, which is the time from when we start the treatment until the patient passes away.
- To evaluate all AE, including TEAE and laboratory test as well as CMR, ORR, PFS and OS data collected during the treatment of the rituximab and chemotherapy combination.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 4
PRD11026427 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD7515218 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD11026428 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
PRD11167270 · Product
- Active substance
- Golcadomide
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 0.4 mg milligram(s)
- Max total dose
- 67.2 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- CELGENE CORPORATION
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 9
SUB06391MIG · Substance
- Active substance
- Doxorubicin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg/m2 milligram(s)/sq. meter
- Max total dose
- 300 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00696MIG · Substance
- Active substance
- Bendamustine Hydrochloride
- Pharmaceutical form
- POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1080 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 168 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 3000 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Betamethasone Sodium Phosphate
SCP107974752 · ATC
- Active substance
- Betamethasone Sodium Phosphate
- Substance synonyms
- BETAMETHASONE DISODIUM PHOSPHATE
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB06 — PREDNISOLONE
- 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)/square meter
- Max total dose
- 7875 mg/m2 milligram(s)/square meter
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical label for the purpose of this trial
SUB12570MIG · Substance
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 1400 mg milligram(s)
- Max total dose
- 28000 mg milligram(s)
- Max treatment duration
- 24 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Clinical label for the purpose of this trial
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 12 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05101MIG · Substance
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg milligram(s)
- Max total dose
- 12 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 4500 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 1
SUB16451MIG · Substance
- Active substance
- Pegfilgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 9999 mg/ml milligram(s)/millilitre
- Max total dose
- 9999 mg/ml milligram(s)/millilitre
- Max treatment duration
- 9999 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
Celgene Corp.
- Sponsor organisation
- Celgene Corp.
- Address
- Route 206 And Province Line Road
- City
- Princeton
- Postcode
- 08543-4000
- Country
- United States
Scientific contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Public contact point
- Organisation
- Celgene Corp.
- Contact name
- GSM-CT
Third parties 11
| Organisation | City, country | Duties |
|---|---|---|
| Azenta Germany GmbH ORG-100022621
|
Griesheim, Germany | Other |
| Syngene International Limited ORG-100012176
|
Bengaluru, India | Other |
| Labcorp Development (Asia) Pte Ltd ORG-100050418
|
Singapore, Singapore | Other |
| Labcorp Development Japan K.K. ORG-100047151
|
Chuo, Japan | Other |
| Yprime LLC ORG-100042888
|
Malvern, United States | Other, Interactive response technologies (IRT) |
| Accenture Solutions Private Limited ORG-100032592
|
Bangaluru, India | Other, Data management |
| Signant Health Global LLC ORG-100040604
|
Blue Bell, United States | Other |
| Accenture Services Pvt. Ltd. ORL-000000127
|
Bengaluru, India | Other |
| Cerba Research ORG-100042694
|
Gent, Belgium | Other |
| Labcorp Central Laboratory Services SARL ORG-100011524
|
Meyrin, Switzerland | Other |
| Labcorp Central Laboratory Services LP ORG-100032236
|
Indianapolis, United States | Other |
Locations
5 EU/EEA countries · 17 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruitment ended | 8 | 4 |
| Germany | Ongoing, recruitment ended | 5 | 3 |
| Italy | Ongoing, recruitment ended | 6 | 4 |
| Poland | Ongoing, recruitment ended | 10 | 3 |
| Spain | Ongoing, recruitment ended | 8 | 3 |
| Rest of world
Australia, Korea, Republic of, United States, Canada, Taiwan, Chile, United Kingdom, Brazil
|
— | 113 | — |
Investigational sites
Institut Curie
Hematology, 35 Rue Dailly, 92210, Saint-Cloud
Centre Hospitalier Universitaire De Poitiers
Haematology and Cell Therapy Department, 2 Rue De La Miletrie, 86000, Poitiers
Hopital Saint Louis
Hematology, 1 Avenue Claude Vellefaux, 75010, Paris
Centre Hospitalier Universitaire De Lille
Hematology, Rue Michel Polonowski, 59000, Lille
Gemeinschaftspraxis Haematologie Onkologie
Haemato- Onkologie, Arnoldstrasse 18, Johannstadt-Nord, Dresden
Barmherzige Brueder gemeinnuetzige Krankenhaus GmbH
Innere Medizin, Haematologie, Pruefeninger Strasse 86, Westenviertel, Regensburg
Klinikum Chemnitz gGmbH
Klinik f. Innere Medizin III, Flemmingstrasse 2, Altendorf, Chemnitz
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Ematologia e oncologia, Viale Oxford 81, 00133, Rome
Humanitas Mirasole S.p.A.
UO Oncologia medica e Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna
IRCCS Istituto Nazionale Tumori Fondazione Pascale
SC Ematologia Oncologia, Via Mariano Semmola 52, 80131, Naples
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 |
|---|---|---|---|---|---|
| France | 2024-10-18 | 2025-01-22 | 2025-10-09 | ||
| Germany | 2024-10-30 | 2024-11-13 | 2025-10-09 | ||
| Italy | 2024-11-14 | 2024-11-22 | 2025-10-09 | ||
| Poland | 2024-10-10 | 2024-10-14 | 2025-10-09 | ||
| Spain | 2024-10-10 | 2024-10-16 | 2025-10-09 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 73 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | CA073-1022__Publication statement | 1 |
| Protocol (for publication) | D1_Protocol 2024-511304-16-00 redacted | 01 |
| Protocol (for publication) | D1_Protocol 2024-511304-16-00_Pregnancy Prevention Plan | 5.0 |
| Protocol (for publication) | D1_Protocol Administrative letter 2024-511304-16-00 redacted | 1 |
| Protocol (for publication) | D4_Blank statement_Patient facing documents-Questionnaires_ES | 1 |
| Protocol (for publication) | D4_patient facing documents__statement_DE | N/A |
| Protocol (for publication) | D4_patient facing documents__statement_under license PL | n/a |
| Protocol (for publication) | D4_Patient facing documents_Blank Statement_FR | 1 |
| Recruitment arrangements (for publication) | K1 Template recruitment arrangements IT | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_DE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_ES_No redaction needed | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_FR | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL_FINAL | 1.0 |
| Recruitment arrangements (for publication) | K2_ Recruitment Material Patient Brochure_IT | 1 |
| Subject information and informed consent form (for publication) | L1_ICF Future Research_DE_Redacted | 2 |
| Subject information and informed consent form (for publication) | L1_ICF Main_DE_Redacted | 03 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Sample Collection upon Progress_DE_Redacted | 02 |
| Subject information and informed consent form (for publication) | L1_ICF Optional Sample Collection_DE_Redacted | 02 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Participant_DE_Ger_sanitised | 01 |
| Subject information and informed consent form (for publication) | L1_ICF Pregnant Partner_DE_sanitised | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF IC Main_final redacted_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_ES_Redacted | 5 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_FR_TC | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main_PL_Redacted | 3.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_FR_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_FR_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Future Research_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection redacted_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_1_ES_Redacted | 3 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Sample Collection_PL_Redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples Collection_FR_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Optional Samples Collection_FR_TC | 2.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant unredacted_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_ES_No redaction needed | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant participant_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Participant_PL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner unredacted_ IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_ES_No redaction needed | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant partner_FR | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnant Partner_PL | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Privacy notice redacted IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Reimbursement redacted_IT | 4 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Optional Future Research redacted_IT | 2 |
| Subject information and informed consent form (for publication) | L1_SIS and Optional Sample Collection_2_ES_Redacted | 2 |
| Subject information and informed consent form (for publication) | L2_global-pregnancy-prevention-plan_DE_ENG | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material pregnancy prevention plan_IT | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pregnancy Prevention Plan_subject facing_FR | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pregnancy Prevention Plan_subject facing_FR_TC | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pregnancy Prevention Plan_subject-facing_ES | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pregnancy Prevention Plan_subject-facing_PL | 6.0 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pregnancy Prevention Plan_whole document_ES_TC | 6 |
| Subject information and informed consent form (for publication) | L2_Other subject information material Pregnancy Prevention Plan_whole document_FR | 6.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E1_SmPC Justification document for no CTIS upload Prednisolone | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bendamustine | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bendamustine_100mg | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Bendamustine_TC | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Cyclophosphamide | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Doxorubicin hydrochloride | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Prednisone | n/a |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rituximab | 63 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rituximab_TC | 63 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rituximab_TC 2 | 63 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vincristine Sulfate | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Vincristine Sulfate_TC | N/A |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-511304-16-00 EN | 03 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis 2024-511304-16-00 EN_Track chnage | 03 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis PL 2024-511304-16_PL | 03 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511304-16_ES | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511304-16_FR | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511304-16_FR_TC | 3 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_2024-511304-16_IT | 3 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-05-31 | Poland | Acceptable 2024-09-23
|
2024-09-24 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-10-09 | Poland | Acceptable 2024-09-23
|
2024-10-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-12-20 | Poland | Acceptable 2025-04-11
|
2025-04-14 |
| 4 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-06 | Poland | Acceptable 2025-08-11
|
2025-08-12 |
| 5 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-09-24 | Acceptable | 2025-10-08 |