Clinical trial • Phase III • Oncology

VENETOCLAX for Acute myeloid leukemia | Myelodysplastic syndromes (MDS)

Phase III trial of VENETOCLAX for Acute myeloid leukemia | Myelodysplastic syndromes (MDS).

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Acute myeloid leukemia | Myelodysplastic syndromes (MDS)
Trial Stage: Phase III
Drug Modality: Small molecule
Orphan Drug: Yes

Key dates

Initial CTIS Submission Date: 18-12-2024
First CTIS Authorization Date: 16-04-2025

Trial design

Randomised, comparator arm: ivosidenib + azacitidine + placebo to match venetoclax (placebo matching venetoclax); investigational arm: ivosidenib + azacitidine + venetoclax (placebo used to enable blinding of venetoclax). doses/schedules: product strengths listed in imp details (e.g., ivosidenib 250 mg tablet; azacitidine powder for injection 75 mg/m2; venetoclax available as 10/50/100 mg tablets) but dosing schedule details not specified in the ctis data.-controlled Phase III trial in Denmark, Ireland, Estonia and others.

Randomised: Yes
Comparator: Comparator arm: ivosidenib + azacitidine + placebo to match venetoclax (placebo matching venetoclax); Investigational arm: ivosidenib + azacitidine + venetoclax (placebo used to enable blinding of venetoclax). Doses/schedules: product strengths listed in IMP details (e.g., ivosidenib 250 mg tablet; azacitidine powder for injection 75 mg/m2; venetoclax available as 10/50/100 mg tablets) but dosing schedule details not specified in the CTIS data.
Biomarker Stratified: True, biomarker: IDH1 mutation (IDH1-mutated AML) - study enrols IDH1-mutated patients
Target Sample Size: 96

Eligibility

Recruits 96 No vulnerable populations selected; study population restricted to adults (Age ≥ 18). Institutional Review Board/Independent Ethics Committee‑approved written informed consent must be obtained from the patient prior to any study-related procedures; patients must be able to understand and be willing to sign the informed consent form. No paediatric assent procedures are described..

Pregnancy Exclusion: 19. The patient is a pregnant or lactating woman, or plans to become pregnant during the study.
Vulnerable Population: No vulnerable populations selected; study population restricted to adults (Age ≥ 18). Institutional Review Board/Independent Ethics Committee‑approved written informed consent must be obtained from the patient prior to any study-related procedures; patients must be able to understand and be willing to sign the informed consent form. No paediatric assent procedures are described.

Inclusion criteria

{"criterion_text":"- 1.\tPatient with newly diagnosed IDH1-mutated AML, or IDH1-mutated MDS/AML according to the 2022 International Consensus Classification. Patients with AML with both IDH1 and IDH2 mutation are eligible as well\n- 2.\tCentral confirmation of IDH1 mutation in one of the dedicated central genetic laboratories.\n- 3.\tAge ≥ 18 years, no upper age limit.\n- 4.\tPatient is ineligible for intensive induction chemotherapy by meeting at least 1 of the following criteria: ≥ 75 years of age: ineligible for intensive chemotherapy per physician’s discretion (with an ECOG performance status 0-2. 18-74 years: patient is not eligible for standard chemotherapy because any of the following co-morbidities: ECOG performance status 2 or 3; Cardiac history of chronic heart failure requiring treatment; or with an ejection fraction ≤50%; or chronic stable angina; DLCO ≤ 65% or FEV1 ≤ 65%; Creatinine clearance ≥ 30 mL/min to <45 ml/min calculated by the Cockcroft Gault formula; Moderate hepatic impairment with total bilirubin > 1.5 to < 3.0 x upper limit of normal (ULN); Any other comorbidity that the local physician assesses to be incompatible with intensive chemotherapy.\n- 5.\tPatient must have a projected life expectancy of at least 12 weeks (as assessed by the treating physician).\n- 6.\tPatient must have a white cell blood (WBC) count of < 25 x 109/L.\n- 7.\tAdequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance ≥ 30 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR).\n- 8.\tAdequate hepatic function as evidenced by: Serum total bilirubin ≤ 3.0 × ULN unless considered due to Gilbert’s disease, or leukemic involvement ; Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement.\n- 9.\tFemale patients: must be of nonchildbearing potential or when of childbearing potential must agree to avoid pregnancy during the study and for 6 months after the final study drug administration; must agree not to breastfeed starting at screening and throughout the study period, and for 2 months and 1 week after the final study drug administration; must agree not to donate ova starting at screening and throughout the study period, and for 6 months after the final study drug administration.\n- 10.\tMen must agree to avoid to father a child (while on therapy and for 6 months after the final study drug administration).\n- 11.\tMale patient must not donate sperm starting at screening and throughout the study period and for 6 months after the final study drug administration.\n- 12.\tAble to understand and willing to sign an informed consent form (ICF).\n- 13.\tInstitutional Review Board/Independent Ethics Committee-approved written informed consent as per national regulations must be obtained from the patient prior to any study-related procedures (including consent for withdrawal of prohibited medication, if applicable)."}

Exclusion criteria

{"criterion_text":"- 1.\tSubject has previously been treated for AML; a treatment period with hydroxyurea to control WBC counts is allowed; prior treatment with a hypomethylating agent for MDS-EB is not allowed; prior treatment with erythropoiesis-stimulating agents or luspatercept for MDS is allowed.\n- 2.\tAcute promyelocytic leukemia (APL) with t(15;17)(q24.1;q21.2); PML-RARA; or one of the other pathognomonic variant chromosomal translocations / fusion genes.\n- 3.\tAML with BCR-ABL1; or myeloid blast crisis of CML.\n- 4.\tSignificant active cardiac disease within 3 months prior to the start of study treatment, including: New York Heart Association (NYHA) class III or IV congestive heart failure; Myocardial infarction; Unstable angina; Severe cardiac arrhythmias; Congenital long QT syndrome of family member with this condition; QTcF >450 msec on screening electrogram for males and >470 msec on screening electrogram for females (mean of triplicate recordings, calculated using Fridericia’s correction).\n- 5.\tFamilial history of sudden death or polymorphic ventricular arrhythmia\n- 6.\tSevere obstructive or restrictive ventilation disorder.\n- 7.\tHistory of stroke or intracranial hemorrhage within 6 months prior to randomization.\n- 8.\tClinical symptoms suggestive of active central nervous system (CNS) leukemia or known CNS leukemia. Evaluation of cerebrospinal fluid (CSF) during screening is only required if there is a clinical suspicion of CNS involvement by leukemia during screening.\n- 9.\tActive infection, including hepatitis B or hepatitis C or Human Immunodeficiency Virus (HIV) infection, that is uncontrolled prior to first dose of study treatment and may interfere with the study objectives or which could expose the patient to undue risk through the participation in the clinical trial; an infection controlled with an approved antibiotic/ antiviral/ antifungal treatment that is not a strong or moderate CYP3A inducer is allowed. Patients with COVID-19 infection can be enrolled, if the patient has no symptoms and was tested negative twice by PCR test prior to inclusion in the trial.\n- 10.\tImmediate life-threatening, severe complications of leukemia such as uncontrolled bleeding and/or disseminated intravascular coagulation.\n- 11.\tConditions that limit the ingestion or gastrointestinal absorption of orally administered drugs.\n- 12.\tPatient with a currently active second malignancy. However, patients with the following history/concurrent conditions are allowed: Basal or squamous cell carcinoma of the skin; Carcinoma in situ of the cervix; Carcinoma in situ of the breast; Incidental histologic finding of prostate cancer.\n- 13.\tReceipt of live, attenuated vaccine within 30 days prior to the study inclusion.\n- 14.\tSevere neurological or psychiatric disorder interfering with ability to give an informed consent.\n- 15.\tContraindication to any of the anti-leukemic agents used (as per SmPC)\n- 16.\tParticipation in other prospective studies with anti-leukemic and/or investigational agents.\n- 17.\tPatient taking Dabigatran unless they can be transferred to other medications at least 3 days prior to dosing. Patients taking other P-gP transporter-sensitive medications should be properly monitored during the study if they cannot be transferred to other medications.\n- 18.\tPatients taking known strong cytochrome P450 (CYP) 3A4 inducers unless they can be transferred to other medications within ≥5 half-lives prior to dosing.\n- 19.\tThe patient is a pregnant or lactating woman, or plans to become pregnant during the study.\n- 20.\tPatient who has once been screened and randomized into this HO173 trial but was considered ineligible cannot re-enter this trial at a later date."}

Endpoints

Primary endpoints

{"endpoint_text":"- EFS in patients with newly diagnosed IDH1-mutated AML, measured from the date of randomization to the date of treatment failure, hematologic relapse from CR/CRh or death from any cause, whichever occurs first. Treatment failure is defined as lack of obtaining either CR or CRh by week 24","definition_or_measurement_approach":"Measured from date of randomization to date of treatment failure, hematologic relapse from CR/CRh or death from any cause; treatment failure defined as lack of obtaining CR or CRh by week 24."}

Secondary endpoints

{"endpoint_text":"- 1. OS in patients with newly diagnosed IDH1-mutated AML measured from the date of randomization to the date of death from any cause.","definition_or_measurement_approach":"Overall survival measured from randomization to death from any cause."}
{"endpoint_text":"- 2.\tRate of CR/CRh in patients with newly diagnosed IDH1-mutated AML, defined as the proportion of AML patients with CR/CRh at any time-point during on treatment period.","definition_or_measurement_approach":"Proportion of patients achieving CR or CRh at any time during on-treatment period."}
{"endpoint_text":"- 3.\tRate of CR in patients with newly diagnosed IDH1-mutated AML defned as the proportion of AML patients with CR at any time-point during protocol treatment","definition_or_measurement_approach":"Proportion of patients achieving CR at any time during protocol treatment."}
{"endpoint_text":"- 4.\tRate of CR/CRi in patients with newly diagnosed IDH1-mutated AML, defined as the proportion of AML patients with CR/CRi at any time point during protocol treatment.","definition_or_measurement_approach":"Proportion of patients achieving CR or CRi at any time during protocol treatment."}
{"endpoint_text":"- 5.\tRates of CR, CR/CRh, and CR/CRi without measurable residual disease (CRMRD-, CR/CRhMRD-, and CR/CRiMRD-) in patients with newly diagnosed IDH1-mutated AML, defined as the proportion of AML patients with CRMRD- / CR/CRhMRD- / CR/CRiMRD- at any time point during protocol treatment.","definition_or_measurement_approach":"Proportion of patients achieving CR/CRh/CRi without measurable residual disease at any time during treatment."}
{"endpoint_text":"- 6.\tTime to achievement of response (CR, CR/CRh, and CR/CRi) in patients with newly diagnosed IDH1-mutated AML, defined as the time from randomization to 1st occurrence of response.","definition_or_measurement_approach":"Time from randomization to first occurrence of CR, CR/CRh or CR/CRi."}
{"endpoint_text":"- 7.\tDuration of response (CR, CR/CRh, and CR/CRi) in patients with newly diagnosed IDH1-mutated AML, measured from the date of achievement of a response until the date of hematologic relapse or death from any cause.","definition_or_measurement_approach":"Measured from date of response to hematologic relapse or death."}
{"endpoint_text":"- 8.\tRate of transfusion independence (platelets and RBC) in patients with newly diagnosed IDH1-mutated AML, defined as the proportion of AML patients who achieved transfusion independence.","definition_or_measurement_approach":"Proportion of patients achieving transfusion independence for platelets and red blood cells."}
{"endpoint_text":"- 9.\tIvosidenib and venetoclax plasma concentrations","definition_or_measurement_approach":"Pharmacokinetic assessment of plasma concentrations of ivosidenib and venetoclax."}
{"endpoint_text":"- 10.\tQuality of life in patients with newly diagnosed IDH1-mutated AML as assessed by EORTC QLC-C30 and EQ-5D-5L forms.","definition_or_measurement_approach":"Patient-reported outcomes measured using EORTC QLQ-C30 and EQ-5D-5L questionnaires."}
{"endpoint_text":"- 11. CIR in adult patients with newly diagnosed IDH1-mutated AML, measured from the date of achievement of a remission (CR/CRh) until the date of hematologic relapse (i.e. not molecular relapse); death without relapse considered as competing risk","definition_or_measurement_approach":"Cumulative incidence of relapse measured from remission to hematologic relapse; death without relapse is a competing risk."}
{"endpoint_text":"- 12. CID in patients with newly diagnosed IDH1-mutated AML, measured from the date of achievement of a remission (CR/CRh) to death without prior relapse; patients not known to have died will be censored at the date of last contact; relapse is considered as competing risk","definition_or_measurement_approach":"Cumulative incidence of death post-remission; relapse treated as competing risk; censoring at last contact if alive."}
{"endpoint_text":"- 13.\tEFS, OS, DoR and rates of CR, CR/CRh and CR/CRi across different subgroups in patients with newly diagnosed IDH1-mutated AML, where the groups are defined based on prognostic characteristics including clinical variables (e.g., age at randomization, sex, ECOG performance status, white blood cell count), risk category according to 2022 ELN recommendations, as well as specific AML genotypes.","definition_or_measurement_approach":"Subgroup analyses of key efficacy endpoints by prognostic variables and AML genotypes."}
{"endpoint_text":"- 14.\tEFS, OS, rates of CR, CR/CRh, CR/CRi, CRMRD-, CR/CRhMRD-, CR/CRiMRD-, time to response, DoR, CIR, CID in patients with newly diagnosed IDH1-mutated MDS/AML.","definition_or_measurement_approach":"Same efficacy measures as primary/secondary applied to the MDS/AML population."}
{"endpoint_text":"- 15.\tTransfusion independence rate and safety endpoints as defined below in patients with newly diagnosed IDH1-mutated MDS/AML.","definition_or_measurement_approach":"Transfusion independence rates and safety endpoints assessed per protocol definitions."}
{"endpoint_text":"- 16.\t 2-HG-plasmaconcentraties","definition_or_measurement_approach":"Measurement of plasma 2-HG concentrations (pharmacodynamic biomarker)."}
{"endpoint_text":"- 17.\tFrequency and severity of AE according to CTCAE version 5.0 in patients with newly diagnosed IDH1-mutated AML.","definition_or_measurement_approach":"Safety assessed as frequency and severity of adverse events per CTCAE v5.0."}
{"endpoint_text":"- 18.\tTime to hematopoietic recovery (absolute neutrophil counts ≥0.5 and ≥1.0 x 109/L; platelets ≥50 and ≥100 x 109/L) after each treatment cycle (but at least for each of the first 6 cycles) in patients with newly diagnosed IDH1-mutated AML, defined as the time from the start of the cycle until recovery.","definition_or_measurement_approach":"Time from cycle start to achieving specified ANC and platelet thresholds after each cycle (at least first 6 cycles)."}
{"endpoint_text":"- 19.\tNumber of patients requiring transfusion (platelet and RBC) and number of units transfused, length of hospital stay, in patients with newly diagnosed IDH1-mutated AML.","definition_or_measurement_approach":"Counts of patients requiring transfusion, units transfused, and hospital length of stay."}

Recruitment

Planned Sample Size: 96
Recruitment Window Months: 90
Consent Approach: IRB/IEC-approved written informed consent must be obtained from the patient prior to any study-related procedures; patients must be able to understand and be willing to sign the informed consent form. Country-specific ICFs and information sheets are provided (published ICF documents available for multiple countries/sites). Study restricted to adults (≥18 years) so no paediatric assent described. ICF language versions and country-specific ICFs are provided (examples in repository: English, Dutch, French, German, Spanish, Italian, Finnish, Swedish, Estonian, Lithuanian, Russian as per the site-specific ICF documents listed).

Geography

Total Number Of Sites: 98
Total Number Of Participants: 180

Denmark

Earliest CTIS Part Ii Submission Date: 04-09-2025
Latest Decision Or Authorization Date: 13-10-2025
Processing Time Days: 39
Number Of Sites: 5
Number Of Participants: 7

Sites

Site Name: Rigshospitalet
Department Name: Department of Hematology
Principal Investigator Name: Claudia Schöllkopf
Principal Investigator Email: claudia.schoellkopf.01@regionh.dk
Contact Person Name: Claudia Schöllkopf
Contact Person Email: claudia.schoellkopf.01@regionh.dk

Site Name: Region Sjaelland
Department Name: Department of Hematology
Principal Investigator Name: Jack Maibom
Principal Investigator Email: jmai@regionsjaellnd.dk
Contact Person Name: Jack Maibom
Contact Person Email: jmai@regionsjaellnd.dk

Site Name: Odense University Hospital
Department Name: Department of Hematology X
Principal Investigator Name: Claus Werenberg Marcher
Principal Investigator Email: claus.marcher@rsyd.dk
Contact Person Name: Claus Werenberg Marcher
Contact Person Email: claus.marcher@rsyd.dk

Site Name: Aalborg University Hospital
Department Name: Department of Hematology
Principal Investigator Name: Gitte Thomsen
Principal Investigator Email: gith@rn.dk
Contact Person Name: Gitte Thomsen
Contact Person Email: gith@rn.dk

Site Name: Region Midtjylland
Department Name: Hematology
Principal Investigator Name: Hans Beier Ommen
Principal Investigator Email: hansomme@rm.dk
Contact Person Name: Hans Beier Ommen
Contact Person Email: hansomme@rm.dk

Ireland

Earliest CTIS Part Ii Submission Date: 29-07-2025
Latest Decision Or Authorization Date: 08-09-2025
Processing Time Days: 41
Number Of Sites: 4
Number Of Participants: 6

Sites

Site Name: Mater Misericordiae University Hospital
Department Name: Haematology
Principal Investigator Name: Michael Fay
Principal Investigator Email: michaelfay@mater.ie
Contact Person Name: Michael Fay
Contact Person Email: michaelfay@mater.ie

Site Name: University Hospital Galway
Department Name: Haematology
Principal Investigator Name: Mark Gurney
Principal Investigator Email: mark.gurney@hse.ie
Contact Person Name: Mark Gurney
Contact Person Email: mark.gurney@hse.ie

Site Name: Cork University Hospital
Department Name: Haematology
Principal Investigator Name: Vitaliy Mykytiv
Principal Investigator Email: vitaliy.mykytiv@hse.ie
Contact Person Name: Vitaliy Mykytiv
Contact Person Email: vitaliy.mykytiv@hse.ie

Site Name: St James's Hospital
Department Name: Haematology
Principal Investigator Name: Nina Orfali
Principal Investigator Email: norfali@stjames.ie
Contact Person Name: Nina Orfali
Contact Person Email: norfali@stjames.ie

Estonia

Earliest CTIS Part Ii Submission Date: 29-08-2025
Latest Decision Or Authorization Date: 05-09-2025
Processing Time Days: 7
Number Of Sites: 2
Number Of Participants: 3

Sites

Site Name: North Estonia Medical Centre Foundation
Department Name: Hematology
Principal Investigator Name: Katrin Palk
Principal Investigator Email: katrin.palk@regionaalhaigla.ee
Contact Person Name: Katrin Palk
Contact Person Email: katrin.palk@regionaalhaigla.ee

Site Name: Tartu University Hospital
Department Name: Hematology and BMT
Principal Investigator Name: Ain Kaare
Principal Investigator Email: ain.kaare@kliinikum.ee
Contact Person Name: Ain Kaare
Contact Person Email: ain.kaare@kliinikum.ee

Norway

Earliest CTIS Part Ii Submission Date: 02-09-2025
Latest Decision Or Authorization Date: 04-09-2025
Processing Time Days: 2
Number Of Sites: 4
Number Of Participants: 6

Sites

Site Name: Oslo University Hospital HF
Department Name: Department of Hematology
Principal Investigator Name: Andrea Lenartova
Principal Investigator Email: anlena@ous-hf.no
Contact Person Name: Andrea Lenartova
Contact Person Email: anlena@ous-hf.no

Site Name: Universitetssykehuset Nord-Norge HF
Department Name: Department of Hematology
Principal Investigator Name: Nils Morten Leknes
Principal Investigator Email: nils.morten.leknes@unn.no
Contact Person Name: Nils Morten Leknes
Contact Person Email: nils.morten.leknes@unn.no

Site Name: Helse Bergen HF
Department Name: Department of Medicine
Principal Investigator Name: Bjørn Tore Gjertsen
Principal Investigator Email: bjorn.tore.gjertsen@helse-bergen.no
Contact Person Name: Bjørn Tore Gjertsen
Contact Person Email: bjorn.tore.gjertsen@helse-bergen.no

Site Name: St. Olavs Hospital HF
Department Name: Department of Haematology
Principal Investigator Name: Anne Sophie von Krogh
Principal Investigator Email: Anne.Sophie.Von.Krogh@stolav.no
Contact Person Name: Anne Sophie von Krogh
Contact Person Email: Anne.Sophie.Von.Krogh@stolav.no

Belgium

Earliest CTIS Part Ii Submission Date: 09-04-2025
Latest Decision Or Authorization Date: 17-04-2025
Processing Time Days: 8
Number Of Sites: 8
Number Of Participants: 14

Sites

Site Name: UZ Leuven
Department Name: Hematology
Principal Investigator Name: Johan Maertens
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Johan Maertens
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire Dinant Godinne Sainte-Elisabeth-UCL-Namur
Department Name: Hematology
Principal Investigator Name: Elodie Collinge
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Elodie Collinge
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre hospitalier universitaire de Liege
Department Name: Hematology
Principal Investigator Name: Adrien De Voeght
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Adrien De Voeght
Contact Person Email: hovon@erasmusmc.nl

Site Name: Ziekenhuis Aan De Stroom
Department Name: Hematology
Principal Investigator Name: Bert Heyrman
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Bert Heyrman
Contact Person Email: hovon@erasmusmc.nl

Site Name: Institut Jules Bordet
Department Name: Hematology
Principal Investigator Name: Hanne Massa
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Hanne Massa
Contact Person Email: hovon@erasmusmc.nl

Site Name: Cliniques Universitaires Saint-Luc
Department Name: Hematology
Principal Investigator Name: Violaine Havelange
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Violaine Havelange
Contact Person Email: hovon@erasmusmc.nl

Site Name: UZ Brussel
Department Name: Hematology
Principal Investigator Name: Ann De Becker
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Ann De Becker
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitair Ziekenhuis Gent
Department Name: Hematology
Principal Investigator Name: Anke Delie
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Anke Delie
Contact Person Email: hovon@erasmusmc.nl

Spain

Earliest CTIS Part Ii Submission Date: 23-07-2025
Latest Decision Or Authorization Date: 08-08-2025
Processing Time Days: 16
Number Of Sites: 5
Number Of Participants: 15

Sites

Site Name: Hospital De La Santa Creu I Sant Pau
Department Name: Hematology
Principal Investigator Name: Ana Garrido Diaz
Principal Investigator Email: agarridod@santpau.cat
Contact Person Name: Ana Garrido Diaz
Contact Person Email: agarridod@santpau.cat

Site Name: Hospital Clinic De Barcelona
Department Name: Hematology
Principal Investigator Name: Jordi Esteve Reyner
Principal Investigator Email: jesteve@clinic.cat
Contact Person Name: Jordi Esteve Reyner
Contact Person Email: jesteve@clinic.cat

Site Name: Institut Catala D'oncologia (Girona)
Department Name: Hematology and hematherapy
Principal Investigator Name: Rosa Coll Jorda
Principal Investigator Email: rcoll@iconcologia.net
Contact Person Name: Rosa Coll Jorda
Contact Person Email: rcoll@iconcologia.net

Site Name: Hospital Clinico Universitario De Valencia
Department Name: Hematology
Principal Investigator Name: Maria del Mar Tormo Díaz
Principal Investigator Email: tormo_mar@gva.es
Contact Person Name: Maria del Mar Tormo Díaz
Contact Person Email: tormo_mar@gva.es

Site Name: Institut Catala D'oncologia (Badalona)
Department Name: Hematology
Principal Investigator Name: Susana Vives Pollo
Principal Investigator Email: svives@iconcologia.net
Contact Person Name: Susana Vives Pollo
Contact Person Email: svives@iconcologia.net

Lithuania

Earliest CTIS Part Ii Submission Date: 23-07-2025
Latest Decision Or Authorization Date: 04-09-2025
Processing Time Days: 43
Number Of Sites: 1
Number Of Participants: 2

Sites

Site Name: Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
Department Name: Hematology, Oncology and Transfusion Medicine Center
Principal Investigator Name: Andrius Žučenka
Principal Investigator Email: andrius.zucenka@santa.lt
Contact Person Name: Andrius Žučenka
Contact Person Email: andrius.zucenka@santa.lt

Netherlands

Earliest CTIS Part Ii Submission Date: 12-03-2025
Latest Decision Or Authorization Date: 17-04-2025
Processing Time Days: 36
Number Of Sites: 14
Number Of Participants: 25

Sites

Site Name: Radboud universitair medisch centrum Stichting
Department Name: Hematology
Principal Investigator Name: Jeroen Janssen
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Jeroen Janssen
Contact Person Email: hovon@erasmusmc.nl

Site Name: Haga Hospital
Department Name: Hematology
Principal Investigator Name: Danielle van Lammeren
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Danielle van Lammeren
Contact Person Email: hovon@erasmusmc.nl

Site Name: Amsterdam UMC Stichting
Department Name: Hematology
Principal Investigator Name: Dave De Leeuw
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Dave De Leeuw
Contact Person Email: hovon@erasmusmc.nl

Site Name: Zuyderland Medisch Centrum Stichting
Department Name: Hematology
Principal Investigator Name: Roel Jan Willem van Kampen
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Roel Jan Willem van Kampen
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitair Medisch Centrum Groningen
Department Name: Hematology
Principal Investigator Name: Emanuele Ammatuna
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Emanuele Ammatuna
Contact Person Email: hovon@erasmusmc.nl

Site Name: Albert Schweitzer Ziekenhuis
Department Name: interne geneeskunde
Principal Investigator Name: Peter Westerweel
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Peter Westerweel
Contact Person Email: hovon@erasmusmc.nl

Site Name: Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Department Name: Hematology
Principal Investigator Name: Bastiaan Wouters
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Bastiaan Wouters
Contact Person Email: hovon@erasmusmc.nl

Site Name: Catharina Ziekenhuis Stichting
Department Name: interne geneeskunde/hematologie
Principal Investigator Name: Marjan Cruijsen
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Marjan Cruijsen
Contact Person Email: hovon@erasmusmc.nl

Site Name: Amphia Hospital
Department Name: Hematology
Principal Investigator Name: Roel Fiets
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Roel Fiets
Contact Person Email: hovon@erasmusmc.nl

Site Name: Jeroen Bosch Ziekenhuis Stichting
Department Name: Oncologie/hematologie
Principal Investigator Name: Alexandra Herbers
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Alexandra Herbers
Contact Person Email: hovon@erasmusmc.nl

Site Name: Medisch Spectrum Twente
Department Name: interne geneeskunde
Principal Investigator Name: Tjeerd Snijders
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Tjeerd Snijders
Contact Person Email: hovon@erasmusmc.nl

Site Name: Rijnstate Ziekenhuis Stichting
Department Name: Hematology
Principal Investigator Name: Marloes Cuijpers
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Marloes Cuijpers
Contact Person Email: hovon@erasmusmc.nl

Site Name: Isala Klinieken Stichting
Department Name: Oncology
Principal Investigator Name: Tim de Waal
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Tim de Waal
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitair Medisch Centrum Utrecht
Department Name: Hematology
Principal Investigator Name: Anna van Rhenen
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Anna van Rhenen
Contact Person Email: hovon@erasmusmc.nl

Germany

Earliest CTIS Part Ii Submission Date: 28-02-2025
Latest Decision Or Authorization Date: 16-04-2025
Processing Time Days: 47
Number Of Sites: 27
Number Of Participants: 45

Sites

Site Name: Universitaetsklinikum Tuebingen AöR
Department Name: Department of Internal Medicine II
Principal Investigator Name: Claudia Lengerke Lengerke
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Claudia Lengerke Lengerke
Contact Person Email: hovon@erasmusmc.nl

Site Name: Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Department Name: Department of Medicine III, Hematology/Oncology
Principal Investigator Name: Katharina Gotze
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Katharina Gotze
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitaetsklinikum Ulm AöR
Department Name: Department of Internal Medicine III
Principal Investigator Name: Hartmut Dohner
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Hartmut Dohner
Contact Person Email: hovon@erasmusmc.nl

Site Name: Charite Universitaetsmedizin Berlin KöR (Augustenburger Platz)
Department Name: Department of Hematology
Principal Investigator Name: Jörg Westermann
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Jörg Westermann
Contact Person Email: hovon@erasmusmc.nl

Site Name: SLK-Kliniken Heilbronn GmbH
Department Name: Department of Internal Medicine III
Principal Investigator Name: Markus Lindauer
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Markus Lindauer
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitaetsklinikum Knappschaftskrankenhaus Bochum GmbH
Department Name: Department of Hematology
Principal Investigator Name: Roland Schroers
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Roland Schroers
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitaetsmedizin Greifswald KöR
Department Name: Department of Internal Medicine C - Hematology, Oncology and Stem Cell Transplantation
Principal Investigator Name: Adrian Schwarzer
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Adrian Schwarzer
Contact Person Email: hovon@erasmusmc.nl

Site Name: Gesundheit Nord gGmbH Klinikverbund Bremen
Department Name: Department of Medical Clinic I
Principal Investigator Name: Maher Hanoun
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Maher Hanoun
Contact Person Email: hovon@erasmusmc.nl

Site Name: Klinikum Region Hannover GmbH
Department Name: Department of Hematology, Oncology and Inmunology
Principal Investigator Name: Kim Marienhagen
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Kim Marienhagen
Contact Person Email: hovon@erasmusmc.nl

Site Name: Staedtisches Klinikum Braunschweig gGmbH
Department Name: Department of Hematology and Oncology
Principal Investigator Name: Christoph Schünemann
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Christoph Schünemann
Contact Person Email: hovon@erasmusmc.nl

Site Name: Asklepios Klinik St George
Department Name: Department of Hematology, Oncology and Stem Cell Research
Principal Investigator Name: Ahmet Elmaagacli
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Ahmet Elmaagacli
Contact Person Email: hovon@erasmusmc.nl

Site Name: University Medical Center Hamburg-Eppendorf
Department Name: Department of Medicine II and Polyclinic
Principal Investigator Name: Franziska Modemann
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Franziska Modemann
Contact Person Email: hovon@erasmusmc.nl

Site Name: Staedtisches Klinikum Karlsruhe gGmbH
Department Name: Department of Medical Clinic III
Principal Investigator Name: Mark Ringhoffer
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Mark Ringhoffer
Contact Person Email: hovon@erasmusmc.nl

Site Name: Charite Universitaetsmedizin Berlin KöR (Hindenburgdamm)
Department Name: Hematology, Oncology
Principal Investigator Name: Jörg Westermann
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Jörg Westermann
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitaetsklinikum Bonn AöR
Department Name: Department of internal medicine III
Principal Investigator Name: Lino Teichman
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Lino Teichman
Contact Person Email: hovon@erasmusmc.nl

Site Name: Medizinische Hochschule Hannover
Department Name: Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation
Principal Investigator Name: Felicitas Thol
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Felicitas Thol
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitaet Des Saarlandes
Department Name: Department of Internal Medicine I
Principal Investigator Name: Jörg-Thomas Bittenbring
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Jörg-Thomas Bittenbring
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitaetsklinikum Halle (Saale) AöR
Department Name: Department of Internal Medicine IV, Oncology and Hemostasis
Principal Investigator Name: Michael Heuser
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Michael Heuser
Contact Person Email: hovon@erasmusmc.nl

Site Name: Malteser Norddeutschland gGmbH
Department Name: Department of Hematology
Principal Investigator Name: Nicolai Faber
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Nicolai Faber
Contact Person Email: hovon@erasmusmc.nl

Site Name: Muehlenkreiskliniken AöR
Department Name: Department of Hematology, Oncology and paliative care
Principal Investigator Name: Kai Wille
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Kai Wille
Contact Person Email: hovon@erasmusmc.nl

Site Name: Klinikum Oldenburg AöR
Department Name: Department of Internal Medicine Oncology and Hematology
Principal Investigator Name: Andreas Voss
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Andreas Voss
Contact Person Email: hovon@erasmusmc.nl

Site Name: Medical Center - University Of Freiburg
Department Name: Hematology & Oncology
Principal Investigator Name: Michael Lübbert
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Michael Lübbert
Contact Person Email: hovon@erasmusmc.nl

Site Name: Vivantes Netzwerk fuer Gesundheit GmbH
Department Name: Department of Hematology
Principal Investigator Name: Maike de Wit
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Maike de Wit
Contact Person Email: hovon@erasmusmc.nl

Site Name: Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Department Name: Department of Internal Medicine III
Principal Investigator Name: Michael Kühn
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Michael Kühn
Contact Person Email: hovon@erasmusmc.nl

France

Earliest CTIS Part Ii Submission Date: 21-02-2025
Latest Decision Or Authorization Date: 22-04-2025
Processing Time Days: 60
Number Of Sites: 14
Number Of Participants: 25

Sites

Site Name: Assistance Publique Hopitaux De Paris
Department Name: Hematology
Principal Investigator Name: Mathieu Leclerc
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Mathieu Leclerc
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire De Nantes
Department Name: Hematology
Principal Investigator Name: Pierre Peterlin
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Pierre Peterlin
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire De Lille
Department Name: Hematology
Principal Investigator Name: Celine Berthon
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Celine Berthon
Contact Person Email: hovon@erasmusmc.nl

Site Name: Hospices Civils De Lyon
Department Name: Hematology
Principal Investigator Name: Mael Heiblig
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Mael Heiblig
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier De Versailles
Department Name: Hematology
Principal Investigator Name: Juliette Lambert
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Juliette Lambert
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire De Saint Etienne
Department Name: Hematology
Principal Investigator Name: Emmanuelle Tavernier
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Emmanuelle Tavernier
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire De Rennes
Department Name: Hematology
Principal Investigator Name: Tony Marchand
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Tony Marchand
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire De Caen Normandie
Department Name: Hematology
Principal Investigator Name: Sylvain Chantepie
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Sylvain Chantepie
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire De Bordeaux
Department Name: Hematology
Principal Investigator Name: Pierre-Yves Dumas
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Pierre-Yves Dumas
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Henri Becquerel
Department Name: Hematology
Principal Investigator Name: Emilie Lemasle
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Emilie Lemasle
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire D'Angers
Department Name: Hematology
Principal Investigator Name: Mathilde Hunault-Berger
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Mathilde Hunault-Berger
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire De Montpellier
Department Name: Clinical Hematology
Principal Investigator Name: Ludovic Gabellier
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Ludovic Gabellier
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire De Nice
Department Name: Hematology
Principal Investigator Name: Thomas Cluzeau
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Thomas Cluzeau
Contact Person Email: hovon@erasmusmc.nl

Site Name: Centre Hospitalier Universitaire Grenoble Alpes
Department Name: Hematology
Principal Investigator Name: Martin Carre
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Martin Carre
Contact Person Email: hovon@erasmusmc.nl

Finland

Earliest CTIS Part Ii Submission Date: 26-03-2025
Latest Decision Or Authorization Date: 16-04-2025
Processing Time Days: 21
Number Of Sites: 2
Number Of Participants: 6

Sites

Site Name: HUS-Yhtymae
Department Name: Hematology
Principal Investigator Name: Mika Kontro
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Mika Kontro
Contact Person Email: hovon@erasmusmc.nl

Site Name: Tampere University Hospital
Department Name: Hematology
Principal Investigator Name: Johanna Rimpilainen
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Johanna Rimpilainen
Contact Person Email: hovon@erasmusmc.nl

Austria

Earliest CTIS Part Ii Submission Date: 04-04-2025
Latest Decision Or Authorization Date: 22-04-2025
Processing Time Days: 18
Number Of Sites: 3
Number Of Participants: 4

Sites

Site Name: Vorarlberger Krankenhaus-Betriebsgesellschaft mbH
Department Name: Internal Medicine
Principal Investigator Name: Bernd Hartmann
Principal Investigator Email: bernd.hartmann@lkhf.at
Contact Person Name: Bernd Hartmann
Contact Person Email: bernd.hartmann@lkhf.at

Site Name: SCRI CCCIT Ges.m.b.H.
Department Name: Medical Department with Hematology, Medical oncology, Hemostageology, infectious Diseas
Principal Investigator Name: Michael Leisch
Principal Investigator Email: m.leisch@salk.at
Contact Person Name: Michael Leisch
Contact Person Email: m.leisch@salk.at

Site Name: Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
Department Name: Medical Department
Principal Investigator Name: Elisabeth Koller
Principal Investigator Email: elisabeth.koller@oegk.at
Contact Person Name: Elisabeth Koller
Contact Person Email: elisabeth.koller@oegk.at

Sweden

Earliest CTIS Part Ii Submission Date: 31-03-2025
Latest Decision Or Authorization Date: 16-04-2025
Processing Time Days: 16
Number Of Sites: 4
Number Of Participants: 12

Sites

Site Name: Karolinska University Hospital
Department Name: Medicinska enheten Hematologi
Principal Investigator Name: Martin Jadersten
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Martin Jadersten
Contact Person Email: hovon@erasmusmc.nl

Site Name: Region Skane Skanes Universitetssjukhus
Department Name: VO Hematologi, Onkologi och Strålningsfysik
Principal Investigator Name: Vladimir Lazarevic
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Vladimir Lazarevic
Contact Person Email: hovon@erasmusmc.nl

Site Name: Uppsala University Hospital
Department Name: Sektionen för hematologi
Principal Investigator Name: Anna Robelius
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Anna Robelius
Contact Person Email: hovon@erasmusmc.nl

Site Name: Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Department Name: Sektionen för hematologi och koagulation
Principal Investigator Name: Lovisa Wennström
Principal Investigator Email: hovon@erasmusmc.nl
Contact Person Name: Lovisa Wennström
Contact Person Email: hovon@erasmusmc.nl

Italy

Earliest CTIS Part Ii Submission Date: 29-08-2025
Latest Decision Or Authorization Date: 11-09-2025
Processing Time Days: 13
Number Of Sites: 5
Number Of Participants: 10

Sites

Site Name: ASST Grande Ospedale Metropolitano Niguarda
Department Name: Hematology, Oncology and Molecular Medicine
Principal Investigator Name: Roberto Cairoli
Principal Investigator Email: Roberto.cairoli@ospedaleniguarda.it
Contact Person Name: Roberto Cairoli
Contact Person Email: Roberto.cairoli@ospedaleniguarda.it

Site Name: Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name: Hematology
Principal Investigator Name: Massimo Breccia
Principal Investigator Email: massimo.breccia@uniroma1.it
Contact Person Name: Massimo Breccia
Contact Person Email: massimo.breccia@uniroma1.it

Site Name: Azienda Ospedaliero-Universitaria Di Bologna IRCCS
Department Name: Oncological and Hematological Diseases
Principal Investigator Name: Antonio Curti
Principal Investigator Email: antonio.curti2@unibo.it
Contact Person Name: Antonio Curti
Contact Person Email: antonio.curti2@unibo.it

Site Name: Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name: Hematology
Principal Investigator Name: Ernesta Audisio
Principal Investigator Email: eaudisio@cittadellasalute.to.it
Contact Person Name: Ernesta Audisio
Contact Person Email: eaudisio@cittadellasalute.to.it

Site Name: Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name: Hematology
Principal Investigator Name: Adriano Venditti
Principal Investigator Email: adriano.venditti@uniroma2.it
Contact Person Name: Adriano Venditti
Contact Person Email: adriano.venditti@uniroma2.it

Sponsor

Primary sponsor

Full Name: Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting
Organisation Type: Hospital/Clinic/Other health care facility
Country Of Registered Address: Netherlands

Third parties

{"country":"Netherlands","full_name":"Allucent (NL) B.V.","duties_or_roles":"codes: [1,12,5]","organisation_type":"Pharmaceutical company"}
{"country":"Netherlands","full_name":"Amsterdam UMC Stichting","duties_or_roles":"laboratory anaylysis, biobanking","organisation_type":"Patient organisation/association"}
{"country":"Germany","full_name":"Universitaetsklinikum Ulm AöR","duties_or_roles":"laboratory anaylysis, biobanking","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Germany","full_name":"Medizinische Hochschule Hannover","duties_or_roles":"laboratory anaylysis, biobanking","organisation_type":"Educational Institution"}
{"country":"France","full_name":"Centre Hospitalier Universitaire De Lille","duties_or_roles":"Biobanking; code:4","organisation_type":"Hospital/Clinic/Other health care facility"}
{"country":"Belgium","full_name":"S-Clinica","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}
{"country":"Netherlands","full_name":"Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)","duties_or_roles":"laboratory anaylysis, biobanking","organisation_type":"Hospital/Clinic/Other health care facility"}

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 number EU/1/16/1138/006 (prodAuthStatus 2)
Dose Levels: 100 mg (film-coated tablet)
Maximum Dose: 400 mg (maxDailyDoseAmount)

Investigational Product Name: Venclyxto 50 mg film-coated tablets
Active Substance: VENETOCLAX
Modality: Small molecule
Routes Of Administration: ORAL
Route: Oral
Authorisation Status: Marketing authorisation number EU/1/16/1138/004 (prodAuthStatus 2)
Dose Levels: 50 mg (film-coated tablet)
Maximum Dose: 400 mg (maxDailyDoseAmount)

Investigational Product Name: Venclyxto 10 mg film-coated tablets
Active Substance: VENETOCLAX
Modality: Small molecule
Routes Of Administration: ORAL
Route: Oral
Authorisation Status: Marketing authorisation number EU/1/16/1138/002 (prodAuthStatus 2)
Dose Levels: 10 mg (film-coated tablet)
Maximum Dose: 400 mg (maxDailyDoseAmount)

Investigational Product Name: AG-120/S95031 250mg film-coated tablet
Active Substance: IVOSIDENIB
Modality: Small molecule
Routes Of Administration: ORAL
Route: Oral
Authorisation Status: prodAuthStatus 1; orphan designation EU/3/16/1802
Orphan Designation: Yes
Dose Levels: 250 mg (film-coated tablet)
Maximum Dose: 500 mg (maxDailyDoseAmount)

Investigational Product Name: AZACITIDINE (powder for suspension for injection)
Active Substance: AZACITIDINE
Modality: Small molecule
Routes Of Administration: SUBCUTANEOUS
Route: Subcutaneous
Authorisation Status: prodAuthStatus 2 (euMpNumber SUB05624MIG)
Dose Levels: powder for suspension for injection; dosing by mg/m2
Maximum Dose: 75 mg/m2 (maxDailyDoseAmount)

Investigational Product Name: placebo to match venetoclax 10 mg / 50 mg / 100 mg
Modality: Other

Combination Treatment: Yes

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