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

Who is this study for? Adults with newly diagnosed acute myeloid leukemia or myelodysplastic syndrome with excess blasts-2
Status: Recruiting
Location: See all (91) locations...
Intervention Type: Drug, Combination product, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

• 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.

⁃ 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.

⁃ Male patient must not donate sperm starting at screening and throughout the study period and for 27 weeks after the final study drug administration.

⁃ Able to understand and willing to sign an informed consent form (ICF).

Locations
Other Locations
Austria
Tirol Kliniken GmbH
NOT_YET_RECRUITING
Innsbruck
Kepler Universitaetsklinikum GmbH
NOT_YET_RECRUITING
Linz
Ordensklinikum Linz GmbH
NOT_YET_RECRUITING
Linz
Landeskrankenhaus (LKH) Rankweil, Interne E am Landeskrankenhaus Rankweil
NOT_YET_RECRUITING
Rankweil
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
NOT_YET_RECRUITING
Salzburg
Hanusch Krankenhaus Der Wiener Gebietskrankenkasse
NOT_YET_RECRUITING
Vienna
Belgium
Ziekenhuis Aan De Stroom
NOT_YET_RECRUITING
Antwerp
Az St-Jan Brugge-Oostende A.V.
NOT_YET_RECRUITING
Bruges
Universitair Ziekenhuis Brussel
NOT_YET_RECRUITING
Brussels
Katholieke Universiteit te Leuven
NOT_YET_RECRUITING
Leuven
Algemeen Ziekenhuis Delta
NOT_YET_RECRUITING
Roeselare
CHU UCL NAMUR - Mont Godinne
NOT_YET_RECRUITING
Yvoir
Estonia
North Estonia Medical Centre Foundation
NOT_YET_RECRUITING
Tallinn
Tartu University Hospital
NOT_YET_RECRUITING
Tartu
Finland
Helsinki University Central Hospital Meilahden Kolmiosairaala
NOT_YET_RECRUITING
Helsinki
Tampere University Hospital
NOT_YET_RECRUITING
Tampere
Germany
Klinikum Aschaffenburg-Alzenau gGmbH
RECRUITING
Aschaffenburg
HELIOS Klinikum Bad Saarow GmbH
NOT_YET_RECRUITING
Bad Saarow
Charité Berlin - Campus Benjamin Franklin
RECRUITING
Berlin
Charité Berlin - Campus Mitte
RECRUITING
Berlin
Charité Berlin - Campus Virchow Klinikum
RECRUITING
Berlin
Vivantes am Urban
NOT_YET_RECRUITING
Berlin
Vivantes Neukölln
NOT_YET_RECRUITING
Berlin
Vivantes Spandau
WITHDRAWN
Berlin
Knappschaftskrankenhaus Bochum-Langendreer
RECRUITING
Bochum
Uniklinikum Bonn
RECRUITING
Bonn
Staedtisches Klinikum Braunschweig
RECRUITING
Braunschweig
Gesundheit Nord gGmbH Klinikverbund Bremen
RECRUITING
Bremen
Klinikum Darmstadt GmbH
NOT_YET_RECRUITING
Darmstadt
St. Johannes Hospital Dortmund
RECRUITING
Dortmund
Marien Hospital Duesseldorf GmbH
WITHDRAWN
Düsseldorf
Klinikum Frankfurt Hoechst GmbH
NOT_YET_RECRUITING
Frankfurt
Justus-Liebig-Universitaet Giessen
RECRUITING
Giessen
Wilhelm-Anton-Hospital Goch
RECRUITING
Goch
Universitätsmedizin Greifswald
RECRUITING
Greifswald
Univeritätsklinikum
NOT_YET_RECRUITING
Halle
Asklepios Klinik Altona
NOT_YET_RECRUITING
Hamburg
Asklepios Klinik St Georg
RECRUITING
Hamburg
Universitätsklinikum Hamburg-Eppendorf
RECRUITING
Hamburg
KRH Klinikum Siloah
NOT_YET_RECRUITING
Hanover
Medizinische Hochschule Hannover
RECRUITING
Hanover
SLK-Kliniken Heilbronn GmbH
NOT_YET_RECRUITING
Heilbronn
Marien Hospital Herne
RECRUITING
Herne
Universitaetsklinikum des Saarlandes AöR
NOT_YET_RECRUITING
Homburg
Wespfalz-Klinikum
NOT_YET_RECRUITING
Kaiserslautern
Städtisches Klinikum Karlsruhe
RECRUITING
Karlsruhe
Staedtisches Klinikum Karlsruhe gGmbH
NOT_YET_RECRUITING
Karlsruhe
UNIVERSITÄTSKLINIKUM Schleswig-Holstein
NOT_YET_RECRUITING
Lübeck
Klinikum der Stadt Ludwigshafen am Rhein gGmbH
RECRUITING
Ludwigshafen
Otto Von Guericke Universitaet Magdeburg
RECRUITING
Magdeburg
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
RECRUITING
Mainz
Klinikum Hochsauerland GmbH
RECRUITING
Meschede
Muhlenkreiskliniken AöR
RECRUITING
Minden
Klinikum rechts der Isar der TU Muenchen AöR
NOT_YET_RECRUITING
München
Ortenauklinikum
NOT_YET_RECRUITING
Offenburg
Klinikum Oldenburg AöR
RECRUITING
Oldenburg
Universitaetsklinikum Regensburg AöR
NOT_YET_RECRUITING
Regensburg
Universitaetsklinikum
NOT_YET_RECRUITING
Rostock
Diakonie Klinikum Stuttgart
RECRUITING
Stuttgart
Klinikum Traunstein
NOT_YET_RECRUITING
Traunstein
Barmherzige Brueder Trier gGmbH
NOT_YET_RECRUITING
Trier
Klinikum Mutterhaus der Borromaerinnen
NOT_YET_RECRUITING
Trier
Uniklinikum Tübingen
RECRUITING
Tübingen
University Hospital Ulm
RECRUITING
Ulm
Schwarzwald-Baar Klinikum Villingen-Schwenningen GmbH
RECRUITING
Villingen-schwenningen
Helios Universitaetsklinikum Wuppertal
NOT_YET_RECRUITING
Wuppertal
Lithuania
Vilnius University Hospital Santaros Klinik
NOT_YET_RECRUITING
Vilnius
Netherlands
Jeroen Bosch ziekenhuis
NOT_YET_RECRUITING
's-hertogenbosch
Meander Medisch Centrum
NOT_YET_RECRUITING
Amersfoort
Amsterdam UMC Stichting
RECRUITING
Amsterdam
OLVG
NOT_YET_RECRUITING
Amsterdam
Rijnstate Ziekenhuis Stichting
NOT_YET_RECRUITING
Arnhem
Amphia Hospital
NOT_YET_RECRUITING
Breda
Reinier de Graaf Gasthuis
NOT_YET_RECRUITING
Delft
Albert Schweitzer Ziekenhuis
NOT_YET_RECRUITING
Dordrecht
Maxima Medisch Centrum
NOT_YET_RECRUITING
Eindhoven
Medisch Spectrum Twente
NOT_YET_RECRUITING
Enschede
UMCG
RECRUITING
Groningen
Medisch Centrum Leeuwarden B.V.
NOT_YET_RECRUITING
Leeuwarden
Leids Universitair Medisch Centrum (LUMC)
NOT_YET_RECRUITING
Leiden
Maastricht University Medical Center+ (MUMC+)
NOT_YET_RECRUITING
Maastricht
Sint Antonius Ziekenhuis Stichting
RECRUITING
Nieuwegein
Radboudumc
RECRUITING
Nijmegen
Erasmus MC - Daniel
NOT_YET_RECRUITING
Rotterdam
Hagaziekenhuis, locatie Leyweg
RECRUITING
The Hague
UMCU
NOT_YET_RECRUITING
Utrecht
Isala Klinieken Stichting
NOT_YET_RECRUITING
Zwolle
Norway
Haukeland University Hospital
NOT_YET_RECRUITING
Bergen
Stavanger Univ. Hosp.-Rogaland Hosp.
NOT_YET_RECRUITING
Oslo
University Hospital of North Norway
NOT_YET_RECRUITING
Tromsø
St. Olavs Hospital
NOT_YET_RECRUITING
Trondheim
Contact Information
Primary
Hartmut Doehner, MD
harmut.doehner@uniklinik-ulm.de
004973150045501
Time Frame
Start Date: 2022-09-13
Estimated Completion Date: 2032-02
Participants
Target number of participants: 650
Treatments
Experimental: 1
standard chemotherapy in combination with venetoclax
Placebo_comparator: 2
standard chemotherapy in combination with placebo
Sponsors
Collaborators: Stichting Hemato-Oncologie voor Volwassenen Nederland
Leads: University of Ulm

This content was sourced from clinicaltrials.gov