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Clinical Trials in Belgium / NCT04628026
Recruiting Phase 3

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

NCT04628026 · tracked via the Priya Life Science Belgium tracker
Phase
Phase 3
Started
2022-09-13
Last updated
2026-09-09

Condition(s) studied

Acute Myeloid Leukemia

Investigational drug(s) / intervention(s)

Venetoclax →PlaceboStandard chemotherapyAllogeneic stem cell transplantation

Venetoclax: Venetoclax will be administered in Induction cycle 1, Induction cycle 2 and in the chemo consolidation therapy in addition to the standard chemotherapy

Placebo: Placebo will be administered in Induction cycle 1, Induction cycle 2 and in the chemo consolidation therapy in addition to the standard chemotherapy

Standard chemotherapy: Induction cycle 1: Patients will receive cytarabine 200 mg/m2 continuous IV (days 1-7) and daunorubicin 60 mg/m2 IV (days 1-3). Induction cycle 2: Patients ≤ 60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-4, and daunorubicin 60 mg/m2 IV (days 1-3). Patients \>60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-4 without daunorubicin. Consolidation chemotherapy with intermediate doses of cytarabine. Patients ≤60 yrs will receive up to 3 cycles of IDAC (single dose 1500 mg/m2 every 12 hours, days 1-3). Patients who are \>60 yrs will receive up to 3 cycles of IDAC with single doses of 1000 mg/m2, every 12 hours, days 1-3. In patients \>60 yrs less than 3 cycles of IDAC or dose-reduced IDAC (500 mg/m2 per single dose) may be given based on an individual risk assessment.

Allogeneic stem cell transplantation: Generally, patients will proceed to allogeneic HCT upon completion of remission induction chemotherapy. It is however allowed, as per investigator's discretion, for a patient to receive 'bridging' consolidation chemotherapy in exceptional cases of delay towards transplantation. At baseline, HLA-compatible donor search must be initiated as soon as possible, first among siblings and second in the world donor bank for unrelated donors or cord blood. In order to avoid inappropriate delay in cases where no suitable sibling is present, high-resolution HLA typing should be performed immediately after registration, enabling a more rapid matched-unrelated donor search. In case no sibling or unrelated donor can be identified, haploidentical allogeneic HCT is allowed. Conditioning and GVHD prophylaxis will take place according to institutional guidelines. Patients who undergo allogeneic HCT will not receive venetoclax during conditioning, engraftment or after hematologic recovery.

Study summary

A Randomized, Placebo-Controlled Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia or Myelodysplastic Syndrome With Excess Blasts-2

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Patients with newly diagnosed acute myeloid leukemia (AML) according to the International Consensus Classification (ICC). 2. Age ≥ 18 and ≤ 75 years. 3. Patients considered eligible for intensive chemotherapy. 4. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. 5. Molecular analysis centrally performed in AMLSG and HOVON laboratories. 6. Adequate renal function as evidenced by serum creatinine ≤ 2.0 × upper limit of norm (ULN) or creatinine clearance \>40 mL/min based on the Cockcroft-Gault glomerular filtration rate (GFR). 7. Adequate hepatic function as evidenced by: * Serum total bilirubin ≤ 2.5 × ULN unless considered due to Gilbert's disease, or leukemic involvement following approval by the Principal Investigators or Trial Coordinators of the study * Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3.0 × ULN, unless considered due to leukemic involvement following approval by the Principal Investigators or Trial Coordinators. 8. No prior chemotherapy for AML, except hydroxyurea for up to 14 days during the diagnostic screening phase for the control of peripheral leukemic blasts in patients with leukocytosis (e.g., white blood cell \[WBC\] counts \> 25x109/L); patients may have had previous treatment with erythroid stimulating agents (ESA) or hypomethylating agents (HMAs) for an antecedent phase of MDS; ESA and HMAs have to be stopped at least four weeks before start of study treatment. 9. Patients must not have received a known strong or moderate CYP3A inducer 7 days before start of study treatment. Patients must have no known medical conditions requiring chronic therapy with moderate or strong CYP3A inducers. 10. Female patient must either: * Be of nonchildbearing potential: * Postmenopausal (defined as at least 1 year without any menses) * Documented surgically sterile (e.g. documented hysterectomy, bilateral oophorectomy, bilateral salpingectomy or congenital sterile) or status post hysterectomy (at least 1 month prior to screening) * Or, if of childbearing potential (not surgically sterile and not postmenopausal) * Not planning to become pregnant during the study and for 6 months after the final study drug administration * And have a negative urine or serum pregnancy test at screening * And, if heterosexually active, agree to consistently apply one highly effective\* method of birth control in combination to a barrier method for the duration of the study and for 27 weeks after the final study drug administration \*Highly effective forms of birth control include * Consistent and correct usage of established hormonal contraceptives that inhibit ovulation for at least 1 month prior to taking study drug. (hormonal contraception is only a highly effective method of birth control, if a combined \[estrogen and progestogen containing\] hormonal contraception or a progestogen-only hormonal contraception - both associated with inhibition of ovulation - is used. * Established intrauterine device (IUD) or intrauterine system (IUS) * Bilateral tubal occlusion * Vasectomy - a vasectomy is highly effective contraception method provided the absence of sperm has been confirmed. If not, an additional highly effective method of contraception should be used. * Male is sterile due to a bilateral orchiectomy. * Sexual abstinence is considered a highly effective method only if defined as refraining from heterosexual activity during the entire period of risk associated with the study drug. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical study and the preferred and usual lifestyle of the patient. \*List is not all inclusive. Prior to enrolment, the investigator is responsible for confirming patient will utilize highly effective forms of birth control in combination with a barrier method according to locally accepted standards during the protocol defined period. * Female patient 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. * Female patient must not donate ova starting at screening and throughout the study period, and for 27 weeks after the final study drug administration. 11. Men must use a latex condom during any sexual contact with WOCBP, even if they have undergone a successful vasectomy and must agree to avoid to father a child (while on therapy and for 27 weeks after the final study drug administration). In addition, their female partners of childbearing potential have to use a highly effective method of birth control. 12. Male patient must not donate sperm starting at screening and throughout the study period and for 27 weeks after the final study drug administration. 13. Able to understand and willing to sign an informed consent form (ICF).

Primary outcome measure(s)

Trial sites (91)

FacilityCityRegionStatus
Tirol Kliniken GmbH Innsbruck Austria Not Yet Recruiting
Kepler Universitaetsklinikum GmbH Linz Austria Not Yet Recruiting
Ordensklinikum Linz GmbH Linz Austria Recruiting
Landeskrankenhaus (LKH) Rankweil, Interne E am Landeskrankenhaus Rankweil Rankweil Austria Recruiting
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Salzburg Austria Not Yet Recruiting
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse Vienna Austria Recruiting
Ziekenhuis Aan De Stroom Antwerp Belgium Not Yet Recruiting
Az St-Jan Brugge-Oostende A.V. Bruges Belgium Not Yet Recruiting
Universitair Ziekenhuis Brussel Brussels Belgium Recruiting
Katholieke Universiteit te Leuven Leuven Belgium Not Yet Recruiting
Algemeen Ziekenhuis Delta Roeselare Belgium Recruiting
CHU UCL NAMUR - Mont Godinne Yvoir Belgium Recruiting
North Estonia Medical Centre Foundation Tallinn Estonia Recruiting
Tartu University Hospital Tartu Estonia Recruiting
Helsinki University Central Hospital Meilahden Kolmiosairaala Helsinki Finland Recruiting
Tampere University Hospital Tampere Finland Not Yet Recruiting
Klinikum Aschaffenburg-Alzenau gGmbH Aschaffenburg Germany Recruiting
HELIOS Klinikum Bad Saarow GmbH Bad Saarow Germany Recruiting
Charité Berlin - Campus Mitte Berlin Germany Recruiting
Charité Berlin - Campus Benjamin Franklin Berlin Germany Recruiting
Charité Berlin - Campus Virchow Klinikum Berlin Germany Recruiting
Vivantes am Urban Berlin Germany Not Yet Recruiting
Vivantes Neukölln Berlin Germany Not Yet Recruiting
Vivantes Spandau Berlin Germany Withdrawn
Knappschaftskrankenhaus Bochum-Langendreer Bochum Germany Recruiting
Uniklinikum Bonn Bonn Germany Recruiting
Staedtisches Klinikum Braunschweig Braunschweig Germany Recruiting
Gesundheit Nord gGmbH Klinikverbund Bremen Bremen Germany Recruiting
Klinikum Darmstadt GmbH Darmstadt Germany Not Yet Recruiting
St. Johannes Hospital Dortmund Dortmund Germany Recruiting
Marien Hospital Duesseldorf GmbH Düsseldorf Germany Withdrawn
Klinikum Frankfurt Hoechst GmbH Frankfurt Germany Recruiting
Justus-Liebig-Universitaet Giessen Giessen Germany Recruiting
Wilhelm-Anton-Hospital Goch Goch Germany Recruiting
Universitätsmedizin Greifswald Greifswald Germany Recruiting
Univeritätsklinikum Halle Germany Recruiting
Universitätsklinikum Hamburg-Eppendorf Hamburg Germany Recruiting
Asklepios Klinik Altona Hamburg Germany Recruiting
Asklepios Klinik St Georg Hamburg Germany Recruiting
Medizinische Hochschule Hannover Hanover Germany Recruiting

+ 51 more sites — see the full list on the official registry below.

On this site

📄 Venclexta (venetoclax) drug profile →

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04628026 on ClinicalTrials.gov ↗ ← All trials in Belgium