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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Acute Myeloid Leukemia

In brief

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

Key facts

Study ID

NCT04628026

Run by

University of Ulm

People needed

650

Starts

2022-09-13

Expected to finish

2032-02-01

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with newly diagnosed acute myeloid leukemia (AML) according to the International Consensus Classification (ICC).
• Age ≥ 18 and ≤ 75 years.
• Patients considered eligible for intensive chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
• Molecular analysis centrally performed in AMLSG and HOVON laboratories.
• 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).
• 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.
• 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.
• 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.
• 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.

Where it is running

• Universitätsmedizin Greifswald — Greifswald, Germany (enrolling)
• Asklepios Klinik St Georg — Hamburg, Germany (enrolling)
• Gesundheit Nord gGmbH Klinikverbund Bremen — Bremen, Germany (enrolling)
• Wilhelm-Anton-Hospital Goch — Goch, Germany (enrolling)
• Univeritätsklinikum — Halle, Germany (enrolling)
• Asklepios Klinik Altona — Hamburg, Germany (enrolling)
• Staedtisches Klinikum Braunschweig — Braunschweig, Germany (enrolling)
• Universitair Ziekenhuis Brussel — Brussels, Belgium (enrolling)
• St. Johannes Hospital Dortmund — Dortmund, Germany (enrolling)
• Justus-Liebig-Universitaet Giessen — Giessen, Germany (enrolling)
• Hanusch Krankenhaus Der Wiener Gebietskrankenkasse — Vienna, Austria (enrolling)
• North Estonia Medical Centre Foundation — Tallinn, Estonia (enrolling)
• Tartu University Hospital — Tartu, Estonia (enrolling)
• Universitätsklinikum Hamburg-Eppendorf — Hamburg, Germany (enrolling)
• Uniklinikum Bonn — Bonn, Germany (enrolling)
• Klinikum Aschaffenburg-Alzenau gGmbH — Aschaffenburg, Germany (enrolling)
• HELIOS Klinikum Bad Saarow GmbH — Bad Saarow, Germany (enrolling)
• Charité Berlin - Campus Mitte — Berlin, Germany (enrolling)
• Charité Berlin - Campus Benjamin Franklin — Berlin, Germany (enrolling)
• Charité Berlin - Campus Virchow Klinikum — Berlin, Germany (enrolling)
• Algemeen Ziekenhuis Delta — Roeselare, Belgium (enrolling)
• Klinikum Frankfurt Hoechst GmbH — Frankfurt, Germany (enrolling)
• CHU UCL NAMUR - Mont Godinne — Yvoir, Belgium (enrolling)
• Knappschaftskrankenhaus Bochum-Langendreer — Bochum, Germany (enrolling)
• Medizinische Hochschule Hannover — Hanover, Germany (enrolling)

Full record on ClinicalTrials.gov

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