Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
340
Countries
1
Sites
10
Diffuse large B-cell lymphomas (DLBCL, Diffuse large B-cell lymphoma) and aggressive B-cell lymphomas (HGBCL, High-grade B-cell lymphoma) originate from mature B-cells at various stages of terminal differentiation
The primary objective of the proposed phase 2 study is to evaluate the efficacy and safety of an intervention involving early implementation of second-line treatment in DLBCL/HGBCL patients, initiated based on eligibility including assessment of circulating tumor-derived DNA.
Key facts
- Sponsor
- Instytut Hematologii I Transfuzjologii
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-12-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Medical Research Agency
External identifiers
- EU CT number
- 2024-518275-64-00
- EudraCT number
- 2021-002468-35
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Diagnosis, Therapy
The primary objective of the proposed phase 2 study is to evaluate the efficacy and safety of an intervention involving early implementation of second-line treatment in DLBCL/HGBCL patients, initiated based on eligibility including assessment of circulating tumor-derived DNA.
Conditions and MedDRA coding
Diffuse large B-cell lymphomas (DLBCL, Diffuse large B-cell lymphoma) and aggressive B-cell lymphomas (HGBCL, High-grade B-cell lymphoma) originate from mature B-cells at various stages of terminal differentiation
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.1 | LLT | 10080217 | High-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements | 10029104 |
| 20.1 | LLT | 10080218 | High-grade B-cell lymphoma NOS | 10029104 |
| 21.0 | PT | 10012818 | Diffuse large B-cell lymphoma | 100000004864 |
| 21.0 | PT | 10012823 | Diffuse large B-cell lymphoma stage I | 100000004864 |
| 20.1 | PT | 10080215 | High-grade B-cell lymphoma | 100000004864 |
| 21.0 | PT | 10012821 | Diffuse large B-cell lymphoma recurrent | 100000004864 |
| 21.0 | PT | 10012826 | Diffuse large B-cell lymphoma stage IV | 100000004864 |
| 21.0 | PT | 10012824 | Diffuse large B-cell lymphoma stage II | 100000004864 |
| 21.0 | PT | 10012825 | Diffuse large B-cell lymphoma stage III | 100000004864 |
| 21.0 | PT | 10003922 | B-cell unclassifiable lymphoma high grade | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- Stage I - prescreening 1. patients with a diagnosis of DLBCL or HGBCL, eligible for chemotherapy according to the R-CHOP or R-CHOP-like regimen (DLBCL) or Pola-R-CHP (DLBCL) or DA-EPOCH-R (HGBCL).
- Perform a PET/CT scan to assess disease progression before starting treatment (a description of the result does not have to be available on the day the patient is included in the study).
- Age ≥18 years
- ECOG 0-2 or ECOG 3, if the general condition is due to disease progression
- Consent to effective contraception during the trial with contraception for 14 months for women and 11 months for men after the last dose of immunochemotherapy 6 In women of childbearing age, a negative serum pregnancy test at screening and agreement to use highly effective contraception during the trial and for 14 months after the last dose of chemotherapy (except for patients over 50 years of age with natural amenorrhea for at least 12 months or after a bilateral salpingo-oophorectomy or hysterectomy).7. Signed consent to participate in the Phase I clinical trial.
- Signing consent to participate in Phase I clinical trial.
- Provide access to histopathological material from the disease diagnosis in case of technical difficulties in obtaining sufficient genetic material from cfDNA.
- In the case of planned treatment with Pola-R-CHP, meeting the general and specific eligibility criteria for first-line therapy according to drug program B.12.
- Stage II Patients diagnosed with DLBCL or HGBCL, in complete remission (CR) confirmed by PET-CT after completion of first-line treatment (R-CHOP or R-CHOP-like or Pola-R-CHP in DLBCL patients, DA-EPOCH-R in HGBCL patients). Modifications of standard R-CHOP immunochemotherapy to, for example, R-CHOP-14, addition of etoposide (R-CHOEP), dose changes due to comorbidities or side effects are allowed.
- Available results of the following tests: - quantitative and qualitative analysis of mutation assessment in peripheral blood by CAPP-Seq and ddPCR prior to the start of first-line treatment, or a secured blood sample allowing such analysis; - Quantitative assessment of circulating free DNA (cfDNA) of tumor origin during treatment (after the 2nd cycle of R-CHOP or R-CHOP-like in DLBCL patients, after the 2nd cycle of DA-EPOCH-R in HGBCL patients) and after completion of 1st line treatment or secured blood samples enabling such analysis; - PET-CT before inclusion of first-line treatment and after completion of first-line treatment - PET-CT or CT during 1st line treatment (after 2nd or 3rd cycle of R-CHOP or R-CHOP-like or Pola-R-CHP in DLBCL, after 2nd or 3rd cycle of DA-EPOCH-R for HGBCL).
- Signing informed consent to participate in Phase II clinical trial.).
- Age ≥18 years
Exclusion criteria 20
- Stage I - prescreening Richter syndrome, transformation to DLBCL of indolent lymphomas, G3B follicular lymphoma, lymphomas with intermediate features between DLBCL and Hodgkin's lymphoma.
- The following test results are not available: - quantitative and qualitative analysis of peripheral blood mutation assessment by CAPP-Seq and ddPCR prior to initiation of first-line treatment, or a secured blood sample allowing such analysis; - quantitative assessment of circulating tumor-derived free DNA (cfDNA) during treatment (after the 2nd cycle of R-CHOP or R-CHOP-like or Pola-R-CHP in DLBCL patients, after the 2nd cycle of DA-EPOCH-R in HGBCL patients) and after completion of first-line treatment, or secured blood samples enabling such analysis;
- inability of the patient to sign the informed consent form.
- Stage III DLBCL/HGBCL lymphoma with secondary central nervous system involvement.
- creatinine clearance <30 ml/min.
- DLBCL lymphoma with primary central nervous system involvement.
- Creatinine clearance <30 ml/min.
- Active second primary malignancy other than basal cell carcinoma of the skin
- Treatmentdue due to malignant neoplasm other than basal cell carcinoma of the skin less than 5 years prior to study inclusion.
- Pregnancy and breastfeeding.
- Any other significant abnormality that, in the opinion of the Investigator, excludes the patient from participation in the study or prevents the application of the planned treatment regimens.
- inability of the patient to sign the informed consent form.
- Stage II Lack of CR after completion of first-line treatment.
- Active second primary malignancy other than basal cell carcinoma of the skin.
- Treatment for malignant neoplasm other than basal cell carcinoma of the skin less than 5 years prior to study inclusion.
- Pregnancy and breastfeeding.
- Any other significant abnormality that, in the opinion of the Investigator, excludes the patient from participation in the study or prevents the application of the planned treatment regimens.
- inability of the patient to sign the informed consent form.
- For planned treatment with vedotin polatuzumab under drug program B.12: (a) active, severe infection; (b) bilirubin levels exceeding 1.5 times the upper limit of normal for the laboratory; (c) peripheral neuropathy ≥ grade 2; (d) presence of contraindications to the use of vedotin polatuzumab, bendamustine and rituximab, which are derived from the Summary Product Chracteristcs.
- n addition, for treatment under drug program B.12: (a) disease progression during treatment; (b) occurrence of symptoms of hypersensitivity to any of the drugs used or to mouse proteins or any of the excipients of the formulations; (c) occurrence of intolerable or life-threatening toxicity despite adequate management; (d) diagnosis of progressive multifocal leukoencephalopathy (PML); (e) the occurrence of diseases or conditions that, in the judgment of the treating physician attending physician makes it impossible to continue treatment
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 2
- ORR for second-line treatment initiated based on a diagnostic algorithm that takes into account cfDNA levels.
- The incidence of grade 3 and 4 adverse reactions assessed according to CTCAE v. 5.
Secondary endpoints 3
- Assessment of health-related quality of life using the EORTC QLQ-C30 generic questionnaire.
- Sensitivity, specificity, PPV, NPV of circulating DNA assay measured by NGS and/or ddPCR (individually selected markers) after first-line treatment in relation to the likelihood of maintaining CR status at 36 months of follow-up
- TTNT since the end of first-line treatment, which will be referenced to archival/historical groups of patients treated at hematology centers collaborating in the PLRG
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 18
MINJUVI 200 mg powder for concentrate for solution for infusion
PRD11607801 · Product
- Active substance
- Tafasitamab
- Substance synonyms
- MOR00208, HUMANIZED FC ENGINEERED MONOCLONAL ANTIBODY AGAINST CD19, MOR-208, XMAB-5574
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12 mg/Kg milligram(s)/kilogram
- Max total dose
- 372 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX12 — -
- Marketing authorisation
- EU/1/21/1570/001
- MA holder
- INCYTE BIOSCIENCES DISTRIBUTION B.V.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Polivy 140 mg powder for concentrate for solution for infusion.
PRD7856215 · Product
- Active substance
- Polatuzumab Vedotin
- Substance synonyms
- RO5541077
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1.8 mg/Kg milligram(s)/kilogram
- Max total dose
- 10.8 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX14 — -
- Marketing authorisation
- EU/1/19/1388/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264325 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/006
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264283 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/002
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264267 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 640 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/009
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264284 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/001
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264282 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 5300 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/003
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264285 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 6300 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/007
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD9264271 · Product
- Active substance
- Lenalidomide
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 640 mg milligram(s)
- Max treatment duration
- 336 Day(s)
- Authorisation status
- Authorised
- ATC code
- L04AX04 — -
- Marketing authorisation
- EU/1/07/391/004
- MA holder
- BRISTOL-MYERS SQUIBB PHARMA EEIG
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Krka, 20 mg, tabletki
PRD4542679 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 640 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 23490
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Krka, 40 mg, tabletki
PRD4542680 · Product
- Active substance
- Dexamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 640 mg milligram(s)
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 23491
- MA holder
- KRKA, D.D., NOVO MESTO
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Bendamustine Glenmark, 2,5 mg/ml, proszek do sporządzania koncentratu roztworu do infuzji
PRD3694045 · Product
- Active substance
- Bendamustine Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 90 mg/m2 milligram(s)/square meter
- Max total dose
- 1080 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA09 — -
- Marketing authorisation
- 22803
- MA holder
- GLENMARK PHARMACEUTICALS S.R.O.
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Polivy 30 mg powder for concentrate for solution for infusion.
PRD8520609 · Product
- Active substance
- Polatuzumab Vedotin
- Substance synonyms
- RO5541077
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 1.8 mg/Kg milligram(s)/kilogram
- Max total dose
- 10.8 mg/kg milligram(s)/kilogram
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX14 — -
- Marketing authorisation
- EU/1/19/1388/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Cisplatin Ebewe 1 mg/ml infuusiokonsentraatti, liuosta varten
PRD770188 · Product
- Active substance
- Cisplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 86 mg/m2 milligram(s)/square meter
- Max total dose
- 335 mg/m2 milligram(s)/square meter
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XA01 — CISPLATIN
- Marketing authorisation
- 16566
- MA holder
- EBEWE PHARMA
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Alexan, 50 Mg/Ml, Roztwór Do Infuzji
PRD757283 · Product
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4000 mg/m2 milligram(s)/square meter
- Max total dose
- 16000 mg/m2 milligram(s)/square meter
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- R/1812
- MA holder
- EBEWE PHARMA
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Alexan, 20 Mg/Ml, Roztwór Do Wstrzykiwań
PRD757303 · Product
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 4000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 16000 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 84 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- R/6640
- MA holder
- EBEWE PHARMA
- MA country
- Poland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Riximyo 100 mg concentrate for solution for infusion
PRD6641347 · 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
- 2250 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/17/1184/001
- MA holder
- SANDOZ GMBH
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Riximyo 500 mg concentrate for solution for infusion
PRD6060647 · Product
- Active substance
- Rituximab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 375 mg/m2 milligram(s)/square meter
- Max total dose
- 2250 mg/m2 milligram(s)/square meter
- Max treatment duration
- 126 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FA01 — -
- Marketing authorisation
- EU/1/17/1184/003
- MA holder
- SANDOZ GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 1
YESCARTA 0.4 – 2 x 10e8 cells dispersion for infusion
PRD6563420 · Product
- Active substance
- Axicabtagene Ciloleucel
- Pharmaceutical form
- DISPERSION FOR INFUSION
- Route of administration
- A CELL SUSPENSION FOR DIRECT INTRAMYOCARDIAL INJECTION
- Max daily dose
- 1000000 millilitre(s)/kilogram
- Max total dose
- 2000000 1X 100 milligrams/millilitre
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XX70 — -
- Marketing authorisation
- EU/1/18/1299/001
- MA holder
- KITE PHARMA EU B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/15/1579
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Instytut Hematologii I Transfuzjologii
- Sponsor organisation
- Instytut Hematologii I Transfuzjologii
- Address
- Ul Indiry Gandhi 14
- City
- Warsaw
- Postcode
- 02-776
- Country
- Poland
Scientific contact point
- Organisation
- Instytut Hematologii I Transfuzjologii
- Contact name
- Instytut Hematologii I Transfuzjologii
Public contact point
- Organisation
- Instytut Hematologii I Transfuzjologii
- Contact name
- Instytut Hematologii I Transfuzjologii
Locations
1 EU/EEA country · 10 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Poland | Authorised, recruitment pending | 340 | 10 |
| Rest of world | — | 0 | — |
Investigational sites
Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im M.Kopernika W Lodzi
Oddział Hematoonkologii z Pododdziałem Chemioterapii Dziennej, Ul. Pabianicka 62, 93-513, Lodz
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klinika Transplantacji Szpiku i Onkohematologii, Ul. Wybrzeze Armii Krajowej 15, 44-102, Gliwice
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Klimika Notworów Układu Chłonnego, Ul. Wawelska 15, 02-034, Warsaw
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
Oddzia Klinicznym Hematologii i Profilaktyki Chorób Nowotworowych Zespołu Szpitali Miejskich w Cho, Ul. Strzelcow Bytomskich 11, 41-500, Chorzow
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Hematologii i Chorób Wewnetrznych, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Uniwersyteckie Centrum Kliniczne
Klinika Hematologii i Transplantologii Uniwersyteckie Centrum Kliniczne w Gdańsku, Ul. Debinki 7, 80-211, Gdansk
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku, Ul Tytusa Chalubinskiego 2-2a, 50-368, Wroclaw
Uniwersytet Medyczny Im. Karola Marcinkowskiego W Poznaniu
Klinika hematologii i Transplantacji szpiku, Ul. Heliodora Swiecickiego 4, 60-781, Poznan
Samodzielny Publiczny Szpital Kliniczny Im.Andrzeja Mieleckiego Slaskiego Uniwersytetu Medycznego W Katowicach
Oddział Hematologii i Transplantacji Szpiku, Ul. Francuska 20/24, 40-027, Katowice
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 16 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518275-64-00 | 5 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements blank page | 1 |
| Subject information and informed consent form (for publication) | L1_IS parents_legal guardians and ICF Stage1 | 3 |
| Subject information and informed consent form (for publication) | L1_IS parents_legal guardians and ICF Stage2 | 3 |
| Subject information and informed consent form (for publication) | L1_IS parents_legal guardians and ICF Stage3 | 3 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_ SMPC Revlimid | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Alexan 2 | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Alexan 50MG | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Bendamustine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Cisplatin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Dexametason Krka tabl | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Minjuvi | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Polivy | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Polivy_ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SMPC Riximyo | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Yescarta | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-10 | Poland | Acceptable 2024-11-27
|
2024-12-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-6 | 2025-10-08 | Poland | Acceptable 2025-11-21
|
2025-11-24 |