Clinical trial • Phase III • Oncology
VENETOCLAX for Acute myeloid leukaemia
Phase III trial of VENETOCLAX for Acute myeloid leukaemia.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Acute myeloid leukaemia
- Trial Stage
- Phase III
- Drug Modality
- Small molecule|ADC
Key dates
- Initial CTIS Submission Date
- 21-12-2023
- First CTIS Authorization Date
- 29-04-2024
Trial design
Randomised, comparators described in main objective: dac protocol (induction according to dac protocol); da+m protocol (induction according to da+m protocol); dac protocol plus placebo (for other aml patients). no detailed dose/schedule for comparator arms provided in the record.-controlled Phase III trial across 18 sites in Poland.
- Randomised
- Yes
- Comparator
- Comparators described in main objective: DAC protocol (induction according to DAC protocol); DA+M protocol (induction according to DA+M protocol); DAC protocol plus placebo (for other AML patients). No detailed dose/schedule for comparator arms provided in the record.
- Biomarker Stratified
- True, biomarker: FLT3 gene mutation (FLT3-mutant subgroup vs others) and CBF-AML status (CBF-AML subgroup)
- Target Sample Size
- 520
Eligibility
Recruits 520 Vulnerable population selected (isVulnerablePopulationSelected = true). Informed, written consent is required from participants. Subject information and informed consent form documents are listed (L1, L2, L3), but no further details on assent or specific vulnerable-group consent handling are provided in the record..
- Pregnancy Exclusion
- Pregnancy and breastfeeding
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected = true). Informed, written consent is required from participants. Subject information and informed consent form documents are listed (L1, L2, L3), but no further details on assent or specific vulnerable-group consent handling are provided in the record.
Inclusion criteria
- {"criterion_text":"- Acute Myeloid Leukemia diagnosed according to the WHO 2016 criteria\n- Age ≥ 18 and ≤65 years\n- General condition according to the ECOG scale ≤ 2\n- HCT-CI comorbidity index score ≤ 3\n- Informed, written consent to participate in the study\n- Consent to the use of effective contraception during the study with the use of contraception in both women and men\n- Negative serum or urine pregnancy test in women of childbearing age"}
Exclusion criteria
- {"criterion_text":"- Acute Promyelocytic Leukemia\n- Pregnancy and breastfeeding\n- Other active cancer disease\n- HIV infection\n- Active infection with hepatitis B or C virus\n- Organ failure which is a contraindication to the use of intensive chemotherapy\n- Known hypersensitivity to any of the preparations used in the treatment\n- Other not described above abnormalities that exclude the patient from the study based on the Investigator's assessment"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Event Free Survival (EFS)","definition_or_measurement_approach":"Measured as event-free survival (EFS) according to the study; no further definition provided in the record."}
Secondary endpoints
- {"endpoint_text":"- Complex complete remission with no measurable residual disease (CR+CRh+CRi MRD-)","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- Relapse-free survival (RFS)","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- Cumulative Relapse Rate (CIR)","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- Proportion of patients experiencing complete remission (CR)","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- Proportion of Remission with partial haematological recovery (CRh) or remission with incomplete hematopoietic regeneration (CRi)","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- Proportion of patients who did not achieve a response (NR)","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- Percentage of patients experiencing early death (ED)","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- Percentage of patients undergoing allogeneic transplantation","definition_or_measurement_approach":"No further definition provided in the record."}
- {"endpoint_text":"- EORTC QLQ-C30 score","definition_or_measurement_approach":"Measured by the EORTC QLQ-C30 questionnaire at baseline and after the first induction."}
- {"endpoint_text":"- Proportion of patients experiencing a composite complete remission (cCR)","definition_or_measurement_approach":"No further definition provided in the record."}
Recruitment
- Planned Sample Size
- 520
- Recruitment Window Months
- 44
- Consent Approach
- Informed, written consent required from participants. Subject information and informed consent form documents are listed (L1_ SIS and ICF; L2_ BIOBANKOWANIE...; L3_ BIOBANKOWANIE_UMED; and others). No details on assent, age-specific consent forms for minors, or available languages are provided in the record.
Geography
- Total Number Of Sites
- 18
- Total Number Of Participants
- 520
Poland
- Earliest CTIS Part Ii Submission Date
- 10-04-2024
- Latest Decision Or Authorization Date
- 15-10-2025
- Processing Time Days
- 553
- Number Of Sites
- 18
- Number Of Participants
- 520
Sites
- Site Name
- Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
- Department Name
- Oddział Hematologii i Chorób Wewnętrznych z Pododdziałem Dziennym
- Principal Investigator Name
- Małgorzata Raźny
- Principal Investigator Email
- mrazny@rydygierkrakow.pl
- Contact Person Name
- Małgorzata Raźny
- Contact Person Email
- mrazny@rydygierkrakow.pl
- Site Name
- Szpitale Pomorskie Sp. z o.o.
- Department Name
- Oddział Hematologii i Transplantologii Szpiku
- Principal Investigator Name
- Judyta Strzała
- Principal Investigator Email
- jstrzala@szpitalepomorskie.eu
- Contact Person Name
- Judyta Strzała
- Contact Person Email
- jstrzala@szpitalepomorskie.eu
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddział Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Lidia Gil
- Principal Investigator Email
- lidia.gil@usk.poznan.pl
- Contact Person Name
- Lidia Gil
- Contact Person Email
- lidia.gil@usk.poznan.pl
- Site Name
- Instytut Hematologii I Transfuzjologii
- Department Name
- Klinika Hematologii
- Principal Investigator Name
- Ewa Lech-Marańda
- Principal Investigator Email
- ewamaranda@wp.pl
- Contact Person Name
- Ewa Lech-Marańda
- Contact Person Email
- ewamaranda@wp.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie
- Department Name
- Oddział Hematologii i Transplantologii Szpiku
- Principal Investigator Name
- Janusz Hałka
- Principal Investigator Email
- janusz.halka@poliklinika.net
- Contact Person Name
- Janusz Hałka
- Contact Person Email
- janusz.halka@poliklinika.net
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Imienia Andrzeja Mieleckiego
- Department Name
- Oddział Hematologii i Transplantologii Szpiku
- Principal Investigator Name
- Grzegorz Helbig
- Principal Investigator Email
- ghelbig@o2.pl
- Contact Person Name
- Grzegorz Helbig
- Contact Person Email
- ghelbig@o2.pl
- Site Name
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii I Traumatologii Im.M.Kopernika W Lodzi
- Department Name
- Oddział Hematologii i Transplantologii – Klinika Hematologii
- Principal Investigator Name
- Magdalena Czemerska
- Principal Investigator Email
- m_czemerska@wp.pl
- Contact Person Name
- Magdalena Czemerska
- Contact Person Email
- m_czemerska@wp.pl
- Site Name
- Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu
- Department Name
- Oddział Hematologii
- Principal Investigator Name
- Edyta Cichocka
- Principal Investigator Email
- edytacichocka@gmail.com
- Contact Person Name
- Edyta Cichocka
- Contact Person Email
- edytacichocka@gmail.com
- Site Name
- Medical University Of Warsaw
- Department Name
- Klinika Hematologii, Transplantologii i Chorób Wewnętrznych
- Principal Investigator Name
- Grzegorz Basak
- Principal Investigator Email
- kho.csk@uckwum.pl
- Contact Person Name
- Grzegorz Basak
- Contact Person Email
- kho.csk@uckwum.pl
- Site Name
- Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
- Department Name
- Oddział Hematologii z Pododdziałem Transplantologii Klinicznej
- Principal Investigator Name
- Jacek Krzanowski
- Principal Investigator Email
- hematologia-sek@szpital-brzozow.pl
- Contact Person Name
- Jacek Krzanowski
- Contact Person Email
- hematologia-sek@szpital-brzozow.pl
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- Klinika Hematologii i Transplantologii
- Principal Investigator Name
- Witold Prejzner
- Principal Investigator Email
- wpre@gumed.edu.pl
- Contact Person Name
- Witold Prejzner
- Contact Person Email
- wpre@gumed.edu.pl
- Site Name
- Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Klinika Hematoonkologii i Transplantacji Szpiku
- Principal Investigator Name
- Tomasz Gromek
- Principal Investigator Email
- togromek@gmail.com
- Contact Person Name
- Tomasz Gromek
- Contact Person Email
- togromek@gmail.com
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
- Department Name
- Oddział Kliniczny Kliniki Hematologii
- Principal Investigator Name
- Tomasz Sacha
- Principal Investigator Email
- rejestracja.hematologia@su.krakow.pl
- Contact Person Name
- Tomasz Sacha
- Contact Person Email
- rejestracja.hematologia@su.krakow.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu
- Department Name
- Klinika Hematologii, Nowotworów Krwi i Transplantacji Szpiku
- Principal Investigator Name
- Tomasz Wróbel
- Principal Investigator Email
- wrobeltw@gmail.com
- Contact Person Name
- Tomasz Wróbel
- Contact Person Email
- wrobeltw@gmail.com
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Hematologii z Pododdziałem Chorób Naczyń
- Principal Investigator Name
- Jarosław Piszcz
- Principal Investigator Email
- jaroslaw.piszcz@gmail.com
- Contact Person Name
- Jarosław Piszcz
- Contact Person Email
- jaroslaw.piszcz@gmail.com
- Site Name
- Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy
- Department Name
- Klinika Hematologii
- Principal Investigator Name
- Marta Sobas
- Principal Investigator Email
- hematologia.sekretariat@biziel.pl
- Contact Person Name
- Marta Sobas
- Contact Person Email
- hematologia.sekretariat@biziel.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 Im. Prof. Tadeusza Sokolowskiego Pum W Szczecinie
- Department Name
- Klinika Hematologii z Oddziałem Transplantacji Szpiku
- Principal Investigator Name
- Bogusław Michaliński
- Principal Investigator Email
- boguslaw.michalinski@pum.edu.pl
- Contact Person Name
- Bogusław Michaliński
- Contact Person Email
- boguslaw.michalinski@pum.edu.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich
- Department Name
- Oddział Kliniczny Hematologii i Profilaktyki Chorób Nowotworowych
- Principal Investigator Name
- Piotr Małecki
- Principal Investigator Email
- hematologia@zsm.com.pl
- Contact Person Name
- Piotr Małecki
- Contact Person Email
- hematologia@zsm.com.pl
Sponsor
Primary sponsor
- Full Name
- Medical University Of Lodz
- Organisation Type
- Educational Institution
- Country Of Registered Address
- Poland
Investigational products
- Investigational Product Name
- Venclyxto 100 mg film-coated tablets
- Active Substance
- VENETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- Marketing authorisation EU/1/16/1138/005 (prodAuthStatus:2)
- Maximum Dose
- 400 mg per day (maxDailyDoseAmount: 400 mg)
- Investigational Product Name
- BIODRIBIN, 1 mg/ml, roztwór do infuzji
- Active Substance
- CLADRIBINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE
- Route
- INTRAVENOUS
- Authorisation Status
- Marketing authorisation R/7134 (prodAuthStatus:2) in Poland (authorisationCountryCode: PL)
- Maximum Dose
- 5 mg/m2 per day (maxDailyDoseAmount: 5 mg/m2)
- Investigational Product Name
- Placebo 0mg, film-coated tablets
- Modality
- Other
- Combination Treatment
- Yes
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