Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Authorised, recruiting
Participants planned
267
Countries
7
Sites
48
Acute myeloid leukemia
To determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy
Key facts
- Sponsor
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 27 Feb 2025 → ongoing
- Decision date (initial)
- 2024-11-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- Yes
- Vulnerable population
- No
- Funding sources
- European Commission (HORIZON-MISS-2022-CANCER-01-03 Project)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To determine in R/R AML patients the clinical benefit of low intensity therapy as shown by event-free survival compared to high intensity therapy
Secondary objectives 4
- To determine if low intensity therapy improves overall survival
- To determine if low intensity therapy improves the overall response (CR/CRh/CRi, Morphologic leukemia-free state MLFS)
- To determine if low intensity therapy improves patients-reported quality of life
- To evaluate the safety of low intensity therapies as compared to high intensity therapies
Conditions and MedDRA coding
Acute myeloid leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Non-APL AML defined according WHO 2022 (or ICC 2022) criteria
- 1st or 2nd relapse or refractory according to ELN 2022
- Patient is clinically candidate both to low intensity therapy and to high dose chemotherapy in the opinion of the physician
- Both low intensity therapy and high dose chemotherapy to which patient is candidate are available and can be provided as per local practice
- No specific treatment protocol can be rationally considered better suited to patient needs. This specifically include, but is not limited to i) the availability of a drug that is already demonstrated superior to comparator arm and can be considered the only standard of care ii) specific contraindications related to fitness or any medical conditions that deem to avoid one of the two arms of this randomization iii) patient willingness to avoid one of the two arm of this randomization iv) lack of social support that make unfeasible one of the two arm of this randomization
- Male or Female, aged>18 years
- ECOG performance status <4
- A female participant is eligible to participate if she is not pregnant and not breastfeeding. If Women of childbearing potential (WOCBP), negative serum pregnancy test within 14 days of starting treatment must be obtained. WOCBP must adopt highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”. Male patient and his female partner who is of childbearing potential must use 2 methods of birth control (a condom as a barrier method of contraception and one of the highly effective birth control methods, according to guideline “Recommendation related to contraception and pregnancy testing in clinical trials”. Use of- and compliance to- birth control methods are required beginning at the screening visit and continuing until 6 months following last treatment with study drug.
- Participant is willing and able to give informed consent for participation in the study
Exclusion criteria 3
- Known contraindication to the study drug that will be selected by the treating physician within the list of high or low intensity treatment, according to most update version of SmPC (e.g. hypersensitivity, allergy, organ failure precluding treatment)
- Participation in another clinical trial with any investigational agents within 14 days or 5 drug half-lives (whatever comes first) prior to randomization.
- Active infections or other clinical conditions that in the opinion of the investigator make the patient ineligible to receive study treatment.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Event-free survival is defined as time from randomization to treatment failure, hematologic relapse from CR/CRh/Cri or death from any cause, whichever occurs first
Secondary endpoints 4
- Overall survival, defined as time from randomization to the date of death from any cause
- Overall response rate (CR/CRh/CRi, MLFS) as the best assessment of response during the study treatment and the overall study cohort
- Change in Hematologic Malignancy–Patient-Reported Outcome (HM-PRO) A-total as defined by the HM-PRO questionnaire between screening and end of treatment assessment.
- Proportion of patients experiencing adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 9
SCP54217654 · ATC
- Active substance
- Decitabine
- Substance synonyms
- 5-AZA-2'-DEOXYCYTIDINE, 4-AMINO-1-(2-DEOXY-.BETA.-D-ERYTHRO-PENTOFURANOSYL)-S-TRIAZIN-2(1H)-ONE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 mg/m2 milligram(s)/square meter
- Max total dose
- 20 mg/m2 milligram(s)/square meter
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC08 — DECITABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/06/370
- Modified vs. Marketing Authorisation
- No
—
SCP36094379 · ATC
- Route of administration
- ORAL
- Max daily dose
- 100 mg milligram(s)
- Max total dose
- 100 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XJ03 — GLASDEGIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/17/1923
- Modified vs. Marketing Authorisation
- No
SCP184620 · ATC
- Active substance
- Azacitidine
- Route of administration
- INTRAVENOUS (IV) OR SUBCUTANEOUS (SC)
- Max daily dose
- 75 mg/m2 milligram(s)/square meter
- Max total dose
- 75 mg/m2 milligram(s)/square meter
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC07 — AZACITIDINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP16272936 · ATC
- Active substance
- Venetoclax
- Substance synonyms
- ABT-199, GDC-0199, 4-(4-((2-(4-CHLOROPHENYL)-4,4-DIMETHYLCYCLOHEX-1-EN-1-YL)METHYL)PIPERAZIN-1-YL)-N-((3-NITRO-4-((TETRAHYDRO-2H-PYRAN-4-YLMETHYL)AMINO)PHENYL)SULFONYL)-2-(1H-PYRROLO(2,3-B)PYRIDIN-5-YLOXY)BENZAMIDE
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 400 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX52 — VENETOCLAX
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP142361 · ATC
- Active substance
- Cytarabine
- Substance synonyms
- ARA-C, CYTOSINE ARABINOSIDE
- Route of administration
- INJECTION
- Max daily dose
- 40 mg/m2 milligram(s)/square meter
- Max total dose
- 20 mg/m2 milligram(s)/square meter
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP16260900 · ATC
- Active substance
- Cladribine
- Substance synonyms
- 2-CHLORODEOXYADENOSINE
- Route of administration
- INJECTION
- Max daily dose
- 5 mg/m2 milligram(s)/square meter
- Max total dose
- 5 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB04 — CLADRIBINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP39502294 · ATC
- Active substance
- Gilteritinib
- Substance synonyms
- ASP2215
- Route of administration
- ORAL
- Max daily dose
- 200 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XE54 — GILTERITINIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/17/1961
- Modified vs. Marketing Authorisation
- No
SCP36066504 · ATC
- Active substance
- Ivosidenib
- Substance synonyms
- AG-120
- Route of administration
- ORAL
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01XX62 — IVOSIDENIB
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/16/1802
- Modified vs. Marketing Authorisation
- No
SCP30296356 · ATC
- Active substance
- Gemtuzumab Ozogamicin
- Substance synonyms
- GEMTUZUMAB OZOGAMICIN (GENETICAL RECOMBINATION)
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 3 mg/m2 milligram(s)/square meter
- Max total dose
- 5 mg milligram(s)
- Max treatment duration
- 2 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01FX02 — GEMTUZUMAB OZOGAMICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/00/005
- Modified vs. Marketing Authorisation
- No
Comparator 7
SCP1166197 · ATC
- Active substance
- Mitoxantrone Hydrochloride
- Substance synonyms
- Mitoxantrone dihydrochloride, MITOXANTRONI HYDROCHLORIDUM, DIHYDROXYANTHRACENEDIONE DIHYDROCHLORIDE, MITOZANTRONE HYDROCHLORIDE
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 12 mg/m2 milligram(s)/square meter
- Max total dose
- 12 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB07 — MITOXANTRONE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP11397391 · ATC
- Active substance
- Daunorubicin Hydrochloride
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 90 mg/m2 milligram(s)/square meter
- Max total dose
- 90 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB02 — DAUNORUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP100376572 · ATC
- Active substance
- Etoposide
- Route of administration
- INTRAVENIOUS INFUSION
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 100 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CB01 — ETOPOSIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP107125968 · ATC
- Active substance
- Fludarabine Phosphate
- Substance synonyms
- FLUDARABINE 5'-MONOPHOSPHATE, FLUDARABINE MONOPHOSPHATE
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 30 mg/m2 milligram(s)/square meter
- Max total dose
- 30 mg/m2 milligram(s)/square meter
- Max treatment duration
- 5 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BB05 — FLUDARABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP142361 · ATC
- Active substance
- Cytarabine
- Substance synonyms
- ARA-C, CYTOSINE ARABINOSIDE
- Route of administration
- INJECTION
- Max daily dose
- 6 g gram(s)
- Max total dose
- 18 g gram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01BC01 — CYTARABINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP170002 · ATC
- Active substance
- Idarubicin Hydrochloride
- Substance synonyms
- 4-DEMETHOXYDAUNORUBICIN HYDROCHLORIDE
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 14 mg/m2 milligram(s)/square meter
- Max total dose
- 14 mg/m2 milligram(s)/square meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB06 — IDARUBICIN
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP2015642 · ATC
- Active substance
- Amsacrine
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 125 mg/m2 milligram(s)/square meter
- Max total dose
- 750 mg/m2 milligram(s)/square meter
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XX01 — AMSACRINE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Sponsor organisation
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Address
- Via Piero Maroncelli 40
- City
- Meldola
- Postcode
- 47014
- Country
- Italy
Scientific contact point
- Organisation
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Contact name
- Oriana Nanni
Public contact point
- Organisation
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Contact name
- Oriana Nanni
Third parties 4
| Organisation | City, country | Duties |
|---|---|---|
| Czech Leukemia Study Group - for Life ORL-000009589
|
Brno, Czechia | On site monitoring, Code 12, Code 2, Code 5 |
| Fondazione Gimema Franco Mandelli Onlus ORG-100010442
|
Rome, Italy | On site monitoring, Code 12, Code 2, Code 5 |
| Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V. ORG-100050543
|
Leipzig, Germany | On site monitoring, Code 12, Code 2, Code 5 |
| IIS La Fe ORG-100050641
|
Valencia, Spain | On site monitoring, Code 12, Code 2, Code 5 |
Locations
7 EU/EEA countries · 48 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Czechia | Authorised, recruiting | 30 | 6 |
| Germany | Ongoing, recruiting | 50 | 6 |
| Italy | Ongoing, recruiting | 120 | 27 |
| Lithuania | Ongoing, recruiting | 20 | 1 |
| Portugal | Authorised, recruiting | 20 | 1 |
| Romania | Ongoing, recruiting | 12 | 1 |
| Spain | Ongoing, recruiting | 15 | 6 |
| Rest of world | — | 0 | — |
Investigational sites
Fakultni Nemocnice Ostrava
Haematooncology, 17. Listopadu 1790/5, Poruba, Ostrava
Fakultni Nemocnice Hradec Kralove
Hematology, Sokolska 581, 500 03, Novy Hradec Kralove
University Hospital Olomouc
Department of Haemato-oncology, Zdravotniku 248/7, 779 00, Olomouc
Fakultni Nemocnice Brno
Internal Medicine, Hematology and Oncology, Jihlavska 340/20, Bohunice, Brno
Fakultni Nemocnice Plzen
Haematology and Oncology, Alej Svobody 923/80, 323 00, Plzen 23
Fakultni Nemocnice Kralovske Vinohrady
Hematology, Srobarova 1150/50, Vinohrady, Prague
Universitaetsklinikum Halle (Saale) AöR
Innere Medizin IV (Hämatologie und Onkologie), Ernst-Grube-Strasse 40, Kroellwitz, Halle Saale
Rostock University Medical Center
Innere Medizin, Hämatologie, Ernst-Heydemann-Strasse 6, Hansaviertel, Rostock
Universitaetsmedizin Greifswald KöR
Universitätsmedizin Greifswald Klinik für Innere Medizin C, Hämatologie und Onkologie, Ferdinand-Sauerbruch-Strasse, 17489, Greifswald
Universitaetsklinikum Aachen AöR
Klinik für Hämatologie, Onkologie, Hämostaseologie und Stammzell transplantation, Pauwelsstrasse 30, 52074, Aachen
Heinrich-Braun-Klinikum Zwickau gGmbH
Internal Medicine, Karl-Keil-Strasse 35, Marienthal, Zwickau
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Internal Medicine, Mauerstrasse 5, Suedliche Innenstadt, Halle (Saale)
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
ONCOEMATOLOGIA, Viale Strasburgo 233, 90146, Palermo
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Onco-Hematology, Viale Oxford 81, 00133, Rome
Istituto Oncologico Veneto
Oncohematology Unit and Transplant Unit, Via Dei Carpani 16/z, 31033, Castelfranco Veneto
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Hematology, Via Pietro Albertoni 15, 40138, Bologna
Azienda Unita Sanitaria Locale Della Romagna
Hematology, Viale Vincenzo Randi 5, 48121, Ravenna
Azienda Ospedaliera di Padova
Ematologia, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Socio Sanitaria Territoriale Della Valle Olona
Oncologia, Via Arnaldo Da Brescia 1, 21052, Busto Arsizio
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Hematology, Viale Del Policlinico 155, 00161, Rome
Azienda Unita Sanitaria Locale Della Romagna
Ematologia, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Ospedaliera Ordine Mauriziano Di Torino
Dept of Clinical and Biological Sciences, Via Ferdinando Magellano 1, 10128, Turin
ASST Grande Ospedale Metropolitano Niguarda
Hematology, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Ematologia, Via Francesco Sforza 28, 20122, Milan
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Hematology, Via Antonio Cardarelli 9, 80131, Naples
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Hematology, Piazzale Spedali Civili 1, 25123, Brescia
Azienda Ospedaliero Universitaria Careggi
Experimental and Clinical medicine, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Haematology and Oncology, Corso Bramante 88, 10126, Turin
IRCCS Ospedale Policlinico San Martino
Ematologia e Terapie Cellulari, Largo Rosanna Benzi 10, 16132, Genoa
Azienda Sanitaria Locale Di Pescara
Oncologico-ematologico, UOC Ematologia, Via Renato Paolini 47, 65124, Pescara
Azienda Unita Locale Socio Sanitaria N 8 Berica
Oncologia, Viale Ferdinando Rodolfi 37, 36100, Vicenza
Hospital Santa Maria Della Misericordia
Medicina e chirurgia, Piazzale Giorgio Menghini 1, 06129, Perugia
IRCCS Ospedale Policlinico San Martino
Clinica Ematologica, Dipartimento di Medicina Interna, Largo Rosanna Benzi 10, 16132, Genoa
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Oncohematology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Senese
Hematology, Viale Mario Bracci 2, 53100, Siena
Fondazione IRCCS Policlinico San Matteo
Hematology, Viale Camillo Golgi 19, 27100, Pavia
Azienda Ospedaliero Universitaria Delle Marche
Hematology, Via Conca 71, 60126, Ancona
Casa Sollievo Della Sofferenza
Hematology, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Unita Sanitaria Locale Di Piacenza
Hematology, Via Giuseppe Taverna 49, 29121, Piacenza
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
Hematology, Eiveniu G. 2, Kauno M. Sav., Kaunas
Hospital De Santa Maria E.P.E.
Hematology, Avenida Professor Egas Moniz Piso 3, 1649-028, Lisbon
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida De Fernando Abril Martorell 106, 46026, Valencia
Hospital General Universitario De Albacete
Hematology, Calle Hermanos Falco 37, 02006, Albacete
Hospital General Universitario Dr. Balmis
Hematology, Avinguda Del Pintor Baeza 12, 03010, Alicante
Consorcio Hospital General Universitario De Valencia
Hematology, Avenida Tres Cruces 2, 46014, Valencia
Hospital Clinico Universitario De Valencia
Hematology, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital Universitari Vall D Hebron
Hematology, Passeig De La Vall D'Hebron 119-129, 08035, Barcelona
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 | 2025-11-19 | ||||
| Germany | 2025-03-19 | 2025-04-16 | |||
| Italy | 2025-02-27 | 2025-03-03 | |||
| Lithuania | 2025-04-14 | 2025-09-11 | |||
| Portugal | 2026-02-05 | ||||
| Romania | 2025-08-14 | 2025-08-19 | |||
| Spain | 2025-03-04 | 2025-03-10 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 129 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | 20407_Prot_changes_SM-2 | 3.0 |
| Protocol (for publication) | D1_20407_Prot_2024-514517-35-00_EN_PUB | 3.0 |
| Protocol (for publication) | D4_20407_Quest_FROM-16_EN_PUB | 1 |
| Protocol (for publication) | D4_20407_Quest_HM-PRO_EN_PUB | 1 |
| Protocol (for publication) | Declaration_QoL_Quest | 1 |
| Recruitment arrangements (for publication) | Declaration_language 1 | 1 |
| Recruitment arrangements (for publication) | Declaration_language 2 | 1 |
| Recruitment arrangements (for publication) | K1_20407_Recru_CZ-EN_PUB | 1 |
| Recruitment arrangements (for publication) | K1_20407_Recru_DE_PUB | 1 |
| Recruitment arrangements (for publication) | K1_20407_Recru_ES_PUB | 1 |
| Recruitment arrangements (for publication) | K1_20407_Recru_LT_PUB | 2 |
| Recruitment arrangements (for publication) | K1_20407_Recru_RO_PUB | 1.0 |
| Recruitment arrangements (for publication) | K1_2047_Recru_EN_PUB | 1 |
| Recruitment arrangements (for publication) | K1_2047_Recru_EN_PUB | 1 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Biobank_CZ_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Biobank_DE_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Biobank_ES_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Biobank_IT_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Biobank_LT_PUB | 1 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Biobank_PT_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Biobank_RO_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_CZ_PUB | 3.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_CZ_SM-2_tc | 3.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_DE_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_ES_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_IT_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Living Lab_IT_PUB | 4.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_Living_Lab_IT_SM-2_tc | 3.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_LT_PUB | 3.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_LT_SM-2_tc | 3.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_PT_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L1_20407_ICF_RO_PUB | 3.0 |
| Subject information and informed consent form (for publication) | L2_20407_Privacy_CZ_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L2_20407_Privacy_DE_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L2_20407_Privacy_ES_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L2_20407_Privacy_IT_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L2_20407_Privacy_LT_PUB | 1 |
| Subject information and informed consent form (for publication) | L2_20407_Privacy_PT_PUB | 2.0 |
| Subject information and informed consent form (for publication) | L2_20407_Privacy_RO_PUB | 3.0 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Fludarabine_LT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrina_ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrina_ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_PT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_PT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_PT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_PT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_PT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_PT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Amsacrine_PT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Azacitidine_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Citarabina_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Citarabina_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cladribine_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine_CZ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine_CZ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine_ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine_ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine_LT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine_LT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine_RO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Cytarabine_RO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_LT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_RO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_RO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicin_RO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicine_CZ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicine_ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicine_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicine_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicine_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicine_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Daunorubicine_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Decitabine_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Etoposide_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fludarabina_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fludarabine_CZ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fludarabine_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fludarabine_ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Fludarabine_RO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gemtuzumab_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gemtuzumab_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Gilteritinib_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Glasdegib_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Idarubicina_ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Idarubicina_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Idarubicine_CZ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Idarubicine_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Idarubicine_LT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Idarubicine_RO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ivosidenib_EN | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Mitoxantrone_CZ | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Mitoxantrone_DE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Mitoxantrone_ES | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Mitoxantrone_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Mitoxantrone_LT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Mitoxantrone_RO | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Venetoclax_EN | 1 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_CZ_PUB | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_DE_PUB | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_EN_PUB | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_ES_PUB | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_IT_PUB | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_LT_PUB | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_PT_PUB | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_RO_PUB | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_SM-2_CZ_tc | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_SM-2_DE_tc | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_SM-2_EN_tc | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_SM-2_ES_tc | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_SM-2_IT_tc | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_SM-2_LT_tc | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_SM-2_PT_tc | 3.0 |
| Synopsis of the protocol (for publication) | D1_20407_ProtSyn_2024-514517-35-00_SM-2_RO_tc | 3.0 |
Application history
8 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-01 | Italy | Acceptable 2024-11-25
|
2024-11-27 |
| 2 | SUBSEQUENT ADDITION OF MSC | APP-2 | 2025-03-28 | Acceptable 2024-11-25
|
2025-06-23 | |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-03-28 | Italy | Acceptable | 2025-05-26 |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-04-01 | 2025-05-12 | ||
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-23 | Italy | Acceptable 2025-11-24
|
2025-11-25 |
| 6 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-03-19 | Italy | Acceptable | 2026-05-08 |
| 7 | SUBSTANTIAL MODIFICATION | SM-4 | 2026-03-19 | Acceptable | 2026-04-27 | |
| 8 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-03-19 | Acceptable | 2026-04-22 |