Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Ongoing, recruitment ended
Participants planned
60
Countries
3
Sites
12
Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)
Phase 2: To compare efficacy (ORR - overall response rate) in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL) treated with Rituximab-Gemcitabine-Dexamethasone-Platinum plus either selinexor 40 mg or selinexor 60 mg to R-GDP alone based on the Lugano 2014 Criteria. Phase 3: To compare Progres…
Key facts
- Sponsor
- Karyopharm Therapeutics Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15], Diseases [C] - Neoplasms [C04]
- Trial duration
- 22 Dec 2020 → ongoing
- Decision date (initial)
- 2024-11-12
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- Yes
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-513616-95-00
- EudraCT number
- 2020-000605-84
- ClinicalTrials.gov
- NCT04442022
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacogenomic, Pharmacogenetic, Safety, Therapy, Pharmacodynamic, Efficacy, Pharmacokinetic
Phase 2: To compare efficacy (ORR - overall response rate) in patients with Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL) treated with Rituximab-Gemcitabine-Dexamethasone-Platinum plus either selinexor 40 mg or selinexor 60 mg to R-GDP alone based on the Lugano 2014 Criteria.
Phase 3: To compare Progression-free survival (PFS) in patients with RR DLBCL treated with SR-GDP (selinexor + rituximab, gemcitabine, dexamethasone, platinum) followed by selinexor to PR-GDP (placebo plus rituximab, gemcitabine, dexamethasone, platinum) followed by placebo based on the Lugano 2014 Criteria.
Secondary objectives 1
- Phase 2: To compare PFS in patients with RR DLBC treated with R-GDP plus either selinexor 40 mg or selinexor 60 mg to R-GDP alone based on the Lugano 2014 Criteria. To assess overall survival (OS) in each treatment arm. Phase 3: To evaluate overall response rate (ORR) in patients with RR DLBCL treated with SR-GDP (selinexor + rituximab, gemcitabine, dexamethasone, platinum) followed by selinexor and with SR-GDP (selinexor + rituximab, gemcitabine, dexamethasone, platinum) followed by placebo compared to PR-GDP (placebo plus rituximab, gemcitabine, dexamethasone, platinum) followed by placebo based on the Lugano 2014 Criteria. To assess OS in each treatment arm.
Conditions and MedDRA coding
Relapsed/Refractory Diffuse Large B-Cell Lymphoma (RR DLBCL)
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10012857 | Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) refractory | 10029104 |
| 21.1 | LLT | 10012856 | Diffuse large cell lymphoma (Diffuse large B-cell lymphoma) (Working Formulation) recurrent | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- Patients ≥18 years of age
- Have pathologically confirmed de novo DLBCL or DLBCL transformed from previously diagnosed indolent lymphoma (e.g., follicular lymphoma). Patients with high grade lymphoma with c-MYC, Bcl-2 and/or Bcl-6 rearrangements are eligible (Phase 2 only) (Documentation to be provided)
- Have received at least 1 but no more than 3 prior lines of systemic therapy for the treatment of DLBCL with relapsed or refractory disease following their most recent regimen (Documentation to be provided) • Salvage chemoimmunotherapy followed by stem cell transplantation will be considered as 1 line of systemic therapy • Maintenance therapy will not be counted as a separate line of systemic therapy • Radiation with curative intent for localized DLBCL will not be counted as 1 line of systemic therapy
- Positron emission tomography (PET) positive measurable disease with at least 1 node having longest diameter (LDi) >1.5 cm or 1 extranodal lesion with LDi >1 cm (per the Lugano 2014 Criteria) (Documentation to be provided). The Deauville 5-point scale (D5PS) score assessed on the FDG PET/CT should be between 3 to 5.
- Not intended for HSCT or CAR-T cell therapy based on objective clinical criteria determined by the treating physician. Patients who cannot receive HSCT due to active disease are allowed on study (up to approximately 15% of patients enrolled in each Phase). Documentation on lack of intention to proceed to receive HSCT or CAR-T therapy must be provided by the treating physician.
- Adequate bone marrow function at screening, defined as (Documentation to be provided): • Absolute neutrophil count ≥1 × 109/L • Platelet count ≥100 × 109/L (without platelet transfusion <14 days prior to C1D1) • Hemoglobin ≥8.5g/dl (without red blood cell transfusion <14 days prior to C1D1)
- Circulating lymphocytes ≤50 × 109/L
- Adequate liver and kidney function, defined as (Documentation to be provided): • Aspartate transaminase (AST) or alanine transaminase (ALT) ≤2.5 × upper limit of normal (ULN), or ≤5 × ULN in cases with known lymphoma involvement in the liver • Serum total bilirubin ≤2 × ULN, or ≤5 ULN if due to Gilbert syndrome or in cases with known lymphoma involvement in the liver • Calculated creatinine clearance (CrCl) ≥30 mL/min based on Cockcroft-Gault formula
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
- An estimated life expectancy of >3 months at Screening
- Patients with primary refractory DLBCL defined as no response or relapse within 6 months after ending first-line treatment will be allowed on study
- Agree to highly effective contraception during the duration of the study with contraception use continuing for 12 months after the last dose of study treatment • Female patients of childbearing potential must have a negative serum pregnancy test at Screening and agree to use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment (except patients with non-childbearing potential: Age >50 years and naturally amenorrhoeic for >1 year, or previous bilateral salpingo-oophorectomy, or hysterectomy). • Male patients who are sexually active must use highly effective methods of contraception throughout the study and for 12 months following the last dose of study treatment. Male patients must agree not to donate sperm during the study treatment period and for 12 months following the last dose of study treatment.
Exclusion criteria 17
- DLBCL with mucosa-associated lymphoid tissue (MALT) lymphoma; composite lymphoma (Hodgkin’s lymphoma + non-Hodgkin’s lymphoma [NHL]); DLBCL transformed from diseases other than indolent NHL; primary mediastinal (thymic) large B-cell lymphoma (PMBL); T-cell rich large B-cell lymphoma.
- Any life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator’s opinion, could compromise the patient’s safety, or being compliant with the study procedures
- Uncontrolled (i.e., clinically unstable) infection requiring parenteral antibiotics, antivirals, or antifungals within 7 days prior to first dose of study treatment; however, prophylactic use of these agents is acceptable (including parenteral)
- Patients with active hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infections: • Patients with active HBV are allowed if antiviral therapy for hepatitis B has been given for >8 weeks and viral load is <100 IU/mL prior to first dose of study treatment. • Patients with known history of HCV or found to be HCV antibody positive on screening, are allowed if there is documentation of negative viral load per institutional standard. • Patients with HIV are allowed if they have a negative viral load per institutional standard, and no history of acquired immune deficiency syndrome (AIDS)-defining opportunistic infections in the last year.
- Inability to swallow tablets, malabsorption syndrome, or any other gastrointestinal disease or dysfunction that could interfere with absorption of study treatment
- Breastfeeding or pregnant women
- Inability or unwillingness to sign an informed consent form (ICF)
- In the opinion of the Investigator, patients who are significantly below their ideal body weight
- Patients who received a live attenuated vaccine within prior 28 days of the first dose of study treatment
- Previous treatment with selinexor or other XPO1 inhibitors
- Contraindication to any drug contained in the combination therapy regimen (SR-GDP)
- Known active central nervous system or meningeal involvement due to DLBCL at the time of Screening
- Use of any standard or experimental anti-DLBCL therapy (including nonpalliative radiation, chemotherapy, immunotherapy, radio-immunotherapy, or any other anticancer therapy) <21 days prior to Cycle 1 Day 1 (Prednisone <30 mg or equivalent are permitted; palliative radiation is permitted only if on non-target lesions)
- Any AE, by Cycle 1 Day 1, which has not recovered to Grade ≤1 (Common Terminology Criteria for Adverse Events [CTCAE] v5.0), or returned to baseline, related to the previous DLBCL therapy, except hematological abnormalities (per Inclusion criteria #6) and alopecia
- Major surgery <14 days of Cycle 1 Day 1
- Hematopoietic stem cell transplantation/CAR-T therapy as follows: • Autologous HSCT <100 days or allogeneic HSCT <180 days prior to Cycle 1 Day 1 • Active graft-versus-host disease (GVHD) after allogeneic HSCT (or cannot discontinue GVHD treatment or prophylaxis) • CAR-T infusion <90 days prior to Cycle 1
- Neuropathy Grade ≥2 (CTCAE v5.0)
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- Phase 2: overall response rate (ORR) based on the Lugano Classification 2014.
- Phase 3: Progression-free survival (PFS) based on the Lugano Classification 2014
Secondary endpoints 2
- Phase 2: Progression-free survival (PFS) based on the Lugano Classification 2014. Overall survival
- Phase 3: overall response rate (ORR) based on the Lugano Classification 2014. Overall survival.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 7
Dexametazona Krka 4 mg comprimate
PRD9520304 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- INTRAVENOUS
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 160 mg milligram(s)
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 14158/2021/02
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Romania
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB177942 · Substance
- Active substance
- Selinexor
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 360 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/14/1355
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Although Selinexor is authorized in the EU, clinical trial product batches using the same bulk drug product are packaged by Catalent CTS, LLC (US) and labeled at Almac Clinical Services Limited, Craigavon.
Gemcitabine 2 g Powder for Solution for Infusion
PRD391099 · Product
- Active substance
- Gemcitabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 126 gm/m2 gram(s)/square meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01BC05 — GEMCITABINE
- Marketing authorisation
- PL 20075/0262
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatin 1 mg/ml Concentrate for Solution for Infusion
PRD8604333 · Product
- Active substance
- Cisplatin
- Substance synonyms
- Cis-diamminedichloroplatinum, (SP-4-2)-cis -diamminedichloroplatinum, CDDP
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 75 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- PL 20075/0123
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Hikma 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung
PRD10240124 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/ml milligram(s)/millilitre
- Max total dose
- 1000 mg/ml milligram(s)/millilitre
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 3002152.00.00
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rixathon 500 mg concentrate for solution for infusion
PRD6060692 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 375 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/17/1185/003
- MA holder
- SANDOZ GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Rixathon 500 mg concentrate for solution for infusion
PRD6060651 · Product
- Active substance
- Rituximab
- Substance synonyms
- CT-P10, PF-05280586, ABP 798, BI 695500, JHL1101, HLX01
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 375 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/17/1185/004
- MA holder
- SANDOZ GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- Route of administration
- ORAL
- Max daily dose
- 60 mg milligram(s)
- Max total dose
- 360 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Although selinexor is authorized in the EU, clinical trial product batches using the same bulk drug product are packaged by Catalent CTS, LLC (US) and labeled at Almac Clinical Services Limited, Craigavon.
Auxiliary 6
Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
PRD6059200 · Product
- Active substance
- Filgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 µg/Kg microgram(s)/kilogram
- Max total dose
- 5 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AA02 — FILGRASTIM
- Marketing authorisation
- EU/1/08/495/008
- MA holder
- SANDOZ GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
PRD6059714 · Product
- Active substance
- Filgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 µg/Kg microgram(s)/kilogram
- Max total dose
- 5 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AA02 — FILGRASTIM
- Marketing authorisation
- EU/1/08/495/006
- MA holder
- SANDOZ GMBH
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
PRD6059198 · Product
- Active substance
- Filgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 µg/Kg microgram(s)/kilogram
- Max total dose
- 5 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AA02 — FILGRASTIM
- Marketing authorisation
- EU/1/08/495/005
- MA holder
- SANDOZ GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
PRD6059199 · Product
- Active substance
- Filgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 µg/Kg microgram(s)/kilogram
- Max total dose
- 5 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L03AA02 — FILGRASTIM
- Marketing authorisation
- EU/1/08/495/007
- MA holder
- SANDOZ GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
EMEND 125 mg+80 mg hard capsules
PRD6279198 · Product
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AD12 — -
- Marketing authorisation
- EU/1/03/262/006
- MA holder
- MERCK SHARP & DOHME B.V.
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ondansetron Aurobindo 8 mg Filmtabletten
PRD925043 · Product
- Active substance
- Ondansetron
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 24 mg milligram(s)
- Max total dose
- 1176 mg milligram(s)
- Max treatment duration
- 49 Day(s)
- Authorisation status
- Authorised
- ATC code
- A04AA01 — ONDANSETRON
- Marketing authorisation
- 87835.00.00
- MA holder
- PUREN PHARMA GMBH & CO. KG
- MA country
- Germany
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karyopharm Therapeutics Inc.
- Sponsor organisation
- Karyopharm Therapeutics Inc.
- Address
- 85 Wells Avenue
- City
- Newton
- Postcode
- 02459-3298
- Country
- United States
Scientific contact point
- Organisation
- Karyopharm Therapeutics Inc.
- Contact name
- Clinical Trials Information Desk
Public contact point
- Organisation
- Karyopharm Therapeutics Inc.
- Contact name
- Clinical Trials Information Desk
Third parties 10
| Organisation | City, country | Duties |
|---|---|---|
| Drugdev Inc. ORG-100047542
|
Wayne, United States | Other |
| Almac Clinical Services Limited ORG-100017464
|
Craigavon, United Kingdom (Northern Ireland) | Code 14 |
| Eclinical Solutions LLC ORG-100044778
|
Mansfield, United States | Data management |
| 4g Clinical LLC ORG-100042775
|
Wellesley, United States | Data management |
| PPD (UK) Limited ORG-100022673
|
Cambridge, United Kingdom | Code 8 |
| AIT Bioscience, LLC ORL-000001146
|
Indianapolis, United States | Laboratory analysis |
| Labconnect LLC ORG-100042800
|
Johnson City, United States | Laboratory analysis |
| WCG Clinical Inc. ORG-100040730
|
Bolton, United States | Code 13 |
| Intana Bioscience GmbH ORL-000010152
|
Planegg, Germany | Laboratory analysis |
| Precision for Medicine (HU) Kft. ORG-100040390
|
Budapest XII, Hungary | On site monitoring, Code 12, Code 5 |
Locations
3 EU/EEA countries · 12 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 27 | 6 |
| Poland | Ended | 15 | 3 |
| Spain | Ended | 18 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Oncology, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Oncology, Corso Giuseppe Mazzini 18, 28100, Novara
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Oncology, Via Trabucco 180, 90146, Palermo
Azienda Ospedaliera Sant'anna E San Sebastiano Di Caserta
Oncology, Via Ferdinando Palasciano Snc, 81100, Caserta
Azienda Ospedaliero Universitaria Delle Marche
Hematology, Via Conca 71, 60126, Ancona
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Oncology, Via Mariano Semmola 52, 80131, Naples
Szpitale Pomorskie Sp. z o.o.
Department of Haematology, Ul. Powstania Styczniowego 1, 81-519, Gdynia
Pratia S.A.
N/A, Ul. Tadeusza Rejtana 2, 30-510, Cracow
Pratia S.A.
N/A, Ul. Poznanska 14, 60-185, Skorzewo
Institut Catala D'oncologia
Oncology, Carretera Canyet S/n, 08916, Badalona
Hospital Universitario La Paz
Oncology, Paseo De La Castellana 261, 28046, Madrid
Institut Catala D'oncologia
Oncology, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
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 |
|---|---|---|---|---|---|
| Italy | 2020-12-22 | 2021-02-03 | 2026-04-24 | ||
| Poland | 2021-03-24 | 2022-06-11 | 2021-05-11 | 2021-11-18 | |
| Spain | 2021-02-25 | 2023-08-23 | 2021-06-02 | 2021-10-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 23 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ 2024-513616-95-00_ Protocol_SOC | 7.3 |
| Protocol (for publication) | D1_Protocol_2024-513616-95-00_Tracked | 1 |
| Protocol (for publication) | D1_Redacted Protocol_2024-513616-95-00 | 7.3 |
| Recruitment arrangements (for publication) | K_CTIS placeholder_2024-513616-95 | N/A |
| Recruitment arrangements (for publication) | K_CTIS placeholder_2024-513616-95 | N/A |
| Recruitment arrangements (for publication) | K_CTIS placeholder_2024-513616-95 | N/A |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Genetics_ES_2024-513616-95 | N/A |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Pregnant Partner_ES_2024-513616-95 | N/A |
| Subject information and informed consent form (for publication) | L1 SIS and ICF_Samples_ES_2024-513616-95 | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Master_PL_2024-513616-95 | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_ES_2024-513616-95 | N/A |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_IT_2024-513616-95_Redacted | N/A |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Carboplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Cisplatin 1 mg | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Dexamethasone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Gemcitabine 2g | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC Rituximab 500mg | 1.0 |
| Synopsis of the protocol (for publication) | D1__Protocol Synopsis_EN | 7 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_ES_2024-513616-95-00 | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_IT_2024-513616-95-00 | 7.0 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_Layperson_EN_2024-513616-95-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_PL_2024-513616-95-00 | 7.0 |
| Synopsis of the protocol (for publication) | D1_XPORT-DLBCL-030_Layperson Summary_IT | 7.3 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Italy | Acceptable 2024-11-07
|
2024-11-07 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2024-12-16 | Italy | Acceptable 2024-11-07
|
2024-12-16 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2025-02-26 | Italy | Acceptable 2024-11-07
|
2025-02-26 |
| 4 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-04-01 | Italy | Acceptable 2025-06-25
|
2025-06-26 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-4 | 2025-10-02 | Italy | Acceptable 2025-06-25
|
2025-10-02 |
| 6 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-03-18 | Italy | Acceptable 2026-04-24
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2026-04-24 |