Overview
Sponsor-declared trial summary
Phase
Phase II and Phase III (Integrated)
Status
Authorised, recruiting
Participants planned
312
Countries
9
Sites
31
Acute Myeloid Leukemia
Part A: To identify the optimal dosage regimen of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission …
Key facts
- Sponsor
- Moleculin Biotech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 17 Jun 2025 → ongoing
- Decision date (initial)
- 2025-04-30
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Moleculin Biotech, Inc. (MBI)
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Pharmacokinetic, Efficacy, Safety, Therapy
Part A: To identify the optimal dosage regimen of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed acute myeloid leukemia (AML) as measured by rate of complete remission (CR) after one treatment cycle.
Part B: To confirm the superior efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of CR after one treatment cycle.
Secondary objectives 10
- Part A: To identify the optimal dosage regimen of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by safety and tolerability
- Part A: To compare the plasma pharmacokinetics of annamycin, annamycinol (a metabolite of annamycin), and cytarabine, when Cytarabine Injection is administered in combination with L-Annamycin for Injection (190 versus 230 mg/m2/day) or placebo
- Part A: To compare the efficacy of two dose levels of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by duration of response (DoR)
- Part A: To compare the efficacy of two dose levels of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of subsequent transplantation for subjects who achieve CR or complete remission with partial hematological recovery (CRh) after one treatment cycle (CR + CRh);
- Part B: To compare the efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by DoR
- Part B: To compare the safety and tolerability of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML
- Part B: To compare the efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by rate of subsequent transplantation for subjects who achieve CR or CRh after one treatment cycle (CR + CRh);
- Part B: To further evaluate the plasma pharmacokinetics of annamycin and annamycinol for an additional approximately 25 subjects administered the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A)
- Part A: To compare the efficacy of two dose levels of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by overall survival (OS).
- Part B: To compare the efficacy of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML as measured by OS.
Conditions and MedDRA coding
Acute Myeloid Leukemia
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10000886 | Acute myeloid leukemia | 10029104 |
Study design 2 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Part A: Determination of Optimal Dosage Regimen RDBPC, efficacy, safety, tolerability, and pharmacokinetics study comparing two dose levels of L-Annamycin for Injection (190 versus 230 mg/m2/day) in combination with Cytarabine Injection (2.0 g/m2/day) versus placebo in combination with Cytarabine Injection to identify the optimal dosage regimen as second line therapy for remission
induction in adult subjects with refractory/relapsed AML. Initially, 45 subjects will be randomized 1:1:1 to one of the three treatment arms. Depending on the outcome of the first interim analysis, either 45 additional subjects will be randomized 1:1:1 to one of the three treatment arms (for a total of 30 per treatment arm in Part A) or 30 additional subjects will be randomized 1:1 to either Treatment Arm 1 or Treatment Arm 2/3 (for a total of 30 per treatment arm in Part A, except for the arm that is dropped after the first interim analysis, which will have a total ≥15 and
≤30, depending on how many subjects were enrolled at the point the decision to drop the arm occurs). L-Annamycin for Injection will be administered as an IV infusion over 2 hours. The placebo will be administered the same (i.e., IV infusion over 2 hours). Cytarabine Injection will be administered as an IV infusion over 4 hours. The first day of Cytarabine Injection treatment will start on the first day of L-Annamycin for Injection or placebo treatment (Day 1). On the days where both Cytarabine Injection and L-Annamycin for Injection or placebo are administered, the
Cytarabine Injection infusion will be initiated after the L-Annamycin for Injection or placebo infusion is completed.
|
Randomised Controlled | Double | [{"id":183289,"code":1,"name":"Subject"},{"id":183288,"code":2,"name":"Investigator"}] | Treatment Arm 1: Placebo (0.9% Sodium Chloride Injection, i.e., the diluent for L-Annamycin for Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days Treatment Arm 2: 190 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. Treatment Arm 3: 230 mg/m2/day L-Annamycin for Injection for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days. |
| 2 | Part B: Expansion at Optimal Dosage Regimen RDBPC, efficacy, safety, tolerability, and pharmacokinetics study of the optimal dosage regimen of L-Annamycin for Injection in combination with Cytarabine Injection (as determined in Part A) versus placebo in combination with Cytarabine Injection as second line therapy for remission induction in adult subjects with refractory/relapsed AML. Once the optimal dosage regimen is determined, enrollment will resume under
Part B of the study. Approximately 222 additional subjects with a pathologically confirmed diagnosis of AML who have refractory/relapsed AML after having received only one prior line of therapy (i.e., the same patient population as for Part A) will be enrolled in Part B. Subjects will be enrolled and randomized 1:1 to one of the two treatment arms (i.e., 111 per treatment arm).
|
Randomised Controlled | Double | [{"id":183291,"code":1,"name":"Subject"},{"id":183292,"code":2,"name":"Investigator"}] | Treatment Arm 1: Placebo (0.9% Sodium Chloride Injection) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 1 of Part A) Treatment Arm X: Optimal dosage regimen (as determined in Part A) of L-Annamycin for Injection (190 mg/m2/day or 230 mg/m2/day) for three consecutive days in combination with 2.0 g/m2/day Cytarabine Injection for five consecutive days (i.e., the same as Treatment Arm 2 or 3, respectively, of Part A). |
Regulatory references
- Scientific advice from competent authorities
- Food And Drug Administration
- Plan to share IPD
- No
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- 1. Has a pathologically confirmed diagnosis of AML per the 2022 International Consensus Classification (ICC) (Arber et al. 2022) as adopted in the European LeukemiaNet (ELN) 2022 recommendations for the diagnosis and management of AML (Döhner et al. 2022). The tests and procedures used to establish the diagnosis of AML should be consistent with the ELN’s 2022 recommendations (i.e., Döhner et al. 2022 Table 4 and crossreferenced Table 5)
- 2. Has refractory/relapsed AML after having received only one prior line of therapy, as defined by the protocol
- 3. Between 18 and 80 years of age (inclusive) at the time of signing the ICF
- 4. Has received no chemotherapy, radiation, or major surgery within 2 weeks prior to the first randomized dose of study drug or has recovered from the toxic side effects of that therapy. Hydroxyurea to control white blood cell (WBC) count, supportive measures, and prophylaxes as required under the protocol will be allowed. Treatment of opportunistic or other infections with antibiotics, antifungals, and/or antiviral agents, including therapy for meningeal disease (i.e., intrathecal chemotherapy), per institutional standards of care will be allowed during this period, as long as the symptoms of infection have resolved by 1 week prior to the first dose of randomized study drug
- 5. Has received no investigational therapy within 4 weeks prior to the first randomized dose of study drug
- 6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 at screening.
- 7. Has a life expectancy of greater than six weeks at screening
- 8. Has adequate laboratory results at screening, as per protocol
- 9. Can understand and sign the ICF, can communicate with the PI, and can understand and comply with the requirements of the protocol.
- 10. For women of childbearing potential (WCBP): Must have a negative serum beta-human chorionic gonadotropin (ß-hCG) pregnancy test within 72 hours prior to the first randomized dose of study drug.
- 11. For WCBP: Must agree to not donate ova and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.
- 12. For males with partners who are WCBP: Must agree to not donate sperm and use a highly effective method of birth control from the time of informed consent through 6 months after their last randomized dose of study drug.
Exclusion criteria 12
- 1. Has prior or current diagnosis of acute promyelocytic leukemia (APL) or MDS/AML (as defined in Döhner et al. 2022 Table 1).
- 9. Pregnant or breastfeeding
- 12. Has relapsed or refractory AML with a FLT3 mutation, unless resides in a country where gilteritinib is not available
- 10. Known hypersensitivity to anthracyclines, cytarabine, the excipients of L-Annamycin for Injection or Cytarabine Injection, or contrast media that may be used for the protocol specified GLS assessments
- 2. Received prior mediastinal radiotherapy
- 3. Has central nervous system involvement
- 4. Has impaired cardiac function, as per protocol
- 5. Has clinically relevant serious comorbid medical conditions including, but not limited to, active infection, chronic obstructive or chronic restrictive pulmonary disease, history of positive status for human immunodeficiency virus (virus detected in serum), hepatitis B, or hepatitis C with current serious symptoms or signs of underlying chronic infection, or psychiatric illness/social situations that would limit compliance with study requirements
- 6. Has evidence of mucositis/stomatitis at screening or baseline, or has history of severe (≥Grade 3) mucositis/stomatitis from prior therapy
- 7. Has any condition that, in the opinion of the PI, places the subject at unacceptable risk if he/she were to participate in the study
- 8. Has received prior treatment with L-asparaginase
- 11. Has received a total cumulative prior anthracycline dose of > 300 mg/m2 (daunorubicin equivalent dose).
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Rate of CR after one treatment cycle (35 days ± 14 days after initiation of randomized treatment)
Secondary endpoints 6
- DoR
- OS
- Rate of subsequent transplantation (i.e., alloHSCT/autoHSCT) for subjects who achieve CR or CRh at 35 days ± 14 days after initiation of randomized treatment (CR + CRh)
- Pharmacokinetics of annamycin (Part A and Part B), annamycinol (Part A and Part B), and cytarabine (Part A).
- Safety
- Tolerability
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 2 gm/m2 gram(s)/square meter
- Max total dose
- 20 gm/m2 gram(s)/square meter
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD5672928 · Product
- Active substance
- Annamycin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 230 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1380 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Not Authorised
- ATC code
- L01DB — ANTHRACYCLINES AND RELATED SUBSTANCES
- MA holder
- MOLECULIN BIOTECH, INC
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/24/2910
Comparator 1
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- IV INFUSION
- Max daily dose
- 2 gm/m2 gram(s)/square meter
- Max total dose
- 20 gm/m2 gram(s)/square meter
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
0.9% Sodium Chloride Injection, USP/Ph. Eur./BP/JP
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Moleculin Biotech Inc.
- Sponsor organisation
- Moleculin Biotech Inc.
- Address
- 5300 Memorial Drive Ste 950
- City
- Houston
- Postcode
- 77007-8274
- Country
- United States
Scientific contact point
- Organisation
- Moleculin Biotech Inc.
- Contact name
- J Paul Waymack
Public contact point
- Organisation
- Moleculin Biotech Inc.
- Contact name
- Erikson Wasyl
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Catalyst Clinical Research LLC ORG-100043484
|
Wilmington, United States | On site monitoring, Code 12, Code 5, Data management |
Locations
9 EU/EEA countries · 31 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 10 | 1 |
| Czechia | Authorised, recruitment pending | 10 | 1 |
| France | Authorised, recruitment pending | 20 | 4 |
| Germany | Authorised, recruitment pending | 15 | 2 |
| Italy | Ongoing, recruiting | 30 | 6 |
| Lithuania | Authorised, recruiting | 7 | 1 |
| Poland | Authorised, recruiting | 40 | 7 |
| Romania | Ongoing, recruiting | 15 | 4 |
| Spain | Ongoing, recruiting | 30 | 5 |
| Rest of world
Ukraine, South Africa, United States, Georgia, Egypt, Jordan, Saudi Arabia, Australia, United Arab Emirates, United Kingdom, Korea, Republic of
|
— | 135 | — |
Investigational sites
Institut Jules Bordet
Hematology, Mijlenmeersstraat 90, 1070, Anderlecht
Fakultni Nemocnice Hradec Kralove
IV. interní hematologická klinika, Sokolska 581, Novy Hradec Kralove, Hradec Kralove
Hôpital Michallon (CHU Grenoble)
Hematology, Boulevard de la Chantourne, 38043, Grenoble
Hôpital Saint-Louis
Hematology, 1 Av. Claude Vellefaux, 75010, Paris
Institut De Cancerologie Strasbourg Europe
Hematology, 17 Rue Albert Calmette, 67200, Strasbourg
CHU Angers
Hematology, 4, rue Larrey, ANGERS Cedex 09
Universitaet Rostock
Medizinische Klinik III für Hämatologie, Onkologie und Palliativmedizin, Ernst-Heydemann-Str. 6, 18057, Rostock
Staedtisches Klinikum Braunschweig gGmbH
Medizinische Klinik III, Hämatologie und Onkologie, Celler Strasse 38, 38114, Brunswick
Azienda Unita Sanitaria Locale Della Romagna
Onco-Ematologia, Viale Vincenzo Randi 5, 48121, Ravenna
Humanitas Mirasole S.p.A.
Ematologia, Via Alessandro Manzoni 56, 20089, Rozzano
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Hematology, Via Piero Maroncelli 40, 47014, Meldola
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
UOC Ematologia, Via Pietro Albertoni 15, 40138, Bologna
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
UOC Ematologia e Trapianti di CSE, Largo Francesco Vito 1, 00168, Rome
Azienda Ospedaliero Universitaria Careggi
SOD Ematologia, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Hospital of Lithuanian University of Health Sciences Kauno Klinikos
Oncology and Hematology, Eiveniu 2, Riese, Kaunas
Uniwersytecki Szpital Kliniczny W Bialymstoku
Klinika Hematologii, Ch. Wewn. i Angiologii z Pododdziałem Transplantacji Komórek Krwiotwórczych, Ul. Marii Curie-Sklodowskiej 24a, 15-276, Bialystok
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
Oddział Hematologii, Ul. Sw. Jozefa 53/59, 87-100, Torun
Instytut Hematologii I Transfuzjologii
Klinika Hematologii, Ul Indiry Gandhi 14, 02-776, Warsaw
Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
Klinika Hematologii i Transplantologii, Ul. Unii Lubelskiej 1, 71-252, Szczecin
Pratia Hematologia Sp. z o.o.
Pratia Onkologia, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Uniwersytecki Szpital Kliniczny W Poznaniu
Oddział Hematologii i Transplantacji Szpiku, Ul. Augustyna Szamarzewskiego 84, 60-569, Poznan
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
Oddział Kliniczny Hematologii i Chorób Wewnętrznych z Ośrodkiem Transplantacji Szpiku, Al. Wojska Polskiego 37, 10-228, Olsztyn
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
Haematology, Strada Republicii 34-36, 400015, Cluj-Napoca
Coltea Clinical Hospital
Oncology, Bulevardul I.C.Bratianu nr.1-3, 030171, Bucharest
Spitalul Clinic Municipal Filantropia Craiova
Haematology, Strada Filantropiei No 1, 200143, Craiova
Spitalul Clinic Municipal De Urgenta Timisoara
Haematology, Strada Dima Gheorghe Nr.5, 300079, Timisoara
MD Anderson Cancer Center
Hematology, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Y Politecnico La Fe
Hematology, Avenida Fernando Abril Martorell 106, 46026, Valencia
Hospital Universitario Ramon Y Cajal
Hematology, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
Hospital Universitario Central De Asturias
Hematology, Avenida De Roma S/n, 33011, Oviedo
Institut Catala D'oncologia
Hematology, Carretera Canyet S/n, 08916, Badalona
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 | 2025-09-24 | 2025-10-23 | |||
| Lithuania | 2025-09-05 | ||||
| Poland | 2025-07-31 | ||||
| Romania | 2025-06-25 | 2025-09-12 | |||
| Spain | 2025-06-17 | 2025-08-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 85 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_2024-518359-47-00_for publication | 10.0 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | NA |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | N/A |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_LT | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements_PL | PL |
| Subject information and informed consent form (for publication) | L1 SIS and ICF | 7.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnancy | 1.0 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnancy | 1.1 |
| Subject information and informed consent form (for publication) | L1 SIS and ICF Pregnancy_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_ Future Research SIS and ICF | 1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ENG | 7.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ENG_changes | 7.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ITA | 7.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_ITA_changes | 7.0 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnancy_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnancy_ENG_changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnancy_ITA | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Pregnancy_ITA_changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Privacy Participant_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Privacy Participant_ENG_changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Privacy Participant_ITA | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Privacy Participant_ITA_changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Privacy Pregnancy_ENG_changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Privacy Pregnancy_ITA_changes | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Privacy Pregnant_ENG | 1.1 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF_Privacy Pregnant_ITA | 1.1 |
| Subject information and informed consent form (for publication) | L1_ICF_Sponsor Statement_Belgium | 1 |
| Subject information and informed consent form (for publication) | L1_Main SIS and ICF_PL | 7.0 |
| Subject information and informed consent form (for publication) | L1_Main SIS and ICF_PL_TC | 7.0 |
| Subject information and informed consent form (for publication) | L1_Main SIS and ICF_UA | 7.0 |
| Subject information and informed consent form (for publication) | L1_Main SIS and ICF_UA_TC | 7.0 |
| Subject information and informed consent form (for publication) | L1_Main_SIS and ICF_PL_TC | 3.1 |
| Subject information and informed consent form (for publication) | L1_Main_SIS and ICF_UA_TC | 3.1 |
| Subject information and informed consent form (for publication) | L1_Master SIS and ICF_PL | 6.0 |
| Subject information and informed consent form (for publication) | L1_Master SIS and ICF_PL_TC | 6.0 |
| Subject information and informed consent form (for publication) | L1_Master SIS and ICF_PL_UA | 6.0 |
| Subject information and informed consent form (for publication) | L1_Master SIS and ICF_PL_UA_TC | 6.0 |
| Subject information and informed consent form (for publication) | L1_Pregnancy SIS and ICF_PL | 1.2 |
| Subject information and informed consent form (for publication) | L1_Pregnancy SIS and ICF_PL_TC | 1.2 |
| Subject information and informed consent form (for publication) | L1_Pregnancy SIS and ICF_UA | 1.2 |
| Subject information and informed consent form (for publication) | L1_Pregnancy SIS and ICF_UA_TC | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Main | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_FR BE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF Pregnancy_NL BE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Data_Protection | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_FR BE | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future_Research | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future_Research | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future_Research_tc | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Future_Research_tc | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | 7.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_tc | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Main_tc | 7.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_NL BE | 4.0 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_PL_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_tc | 1.2 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_tc | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_Pregnancy_UA_TC | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_TC | 7.0 |
| Subject information and informed consent form (for publication) | L2_Patient Card_CZE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_USPI Cytarabine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_USPI Cytarabine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis EN_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_CZ_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DE DE_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ESP_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR BE_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_IT_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_LT_2024-518359-47-00 | 10 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_NL BE_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_PL_2024-518359-47-00 | 10.0 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_RO_2024-518359-47-00 | 10.0 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-20 | Poland | Acceptable with conditions 2025-04-29
|
2025-04-30 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-05-15 | Acceptable with conditions | 2025-07-22 | |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-08-20 | Poland | Acceptable with conditions | 2025-08-20 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-22 | Poland | Acceptable 2025-10-26
|
2025-10-27 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2025-12-10 | Poland | Acceptable 2025-10-26
|
2025-12-10 |
| 6 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-12-18 | Poland | Acceptable 2026-02-22
|
2026-02-23 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-3 | 2026-04-27 | Poland | Acceptable 2026-02-22
|
2026-04-27 |