Actively Recruiting
Randomized Study of Revumenib with Azacitidine and Venetoclax in Adults with Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Not Eligible for Intensive Chemotherapy
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2025-04-04
415
Participants Needed
67
Research Sites
82 weeks
Total Duration
On this page
Sponsors
S
Stichting Hemato-Oncologie voor Volwassenen Nederland
Lead Sponsor
G
German-Austrian Acute Myeloid Leukemia Study Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying adult patients with newly diagnosed acute myeloid leukemia (AML) who have specific genetic changes in the NPM1 or KMT2A genes and who are not eligible for intensive chemotherapy. The study aims to find out if adding the drug revumenib to the current treatment with azacitidine and venetoclax can improve outcomes for these patients. This is a phase 3 randomized, double-blind, placebo-controlled trial designed to address the need for better treatment options in this patient group. Participants will be randomly assigned to receive either revumenib or a placebo, both given alongside azacitidine and venetoclax. Treatments are given in continuous 28-day cycles and continue until the disease worsens, unacceptable side effects occur, death, withdrawal, or other protocol-defined reasons. After the treatment phase, a 4-year observational follow-up will track survival and health status. During the study, participants will have regular assessments including laboratory tests and monitoring for side effects. Researchers will measure overall survival as the primary outcome, along with other outcomes such as event-free survival and response rates. The total participation may last several years due to the ongoing follow-up period to capture long-term results and safety data.
CONDITIONS
Brief Title
Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Newly diagnosed AML with NPM1 mutation or KMT2A rearrangement confirmed by central genetic testing
- Not eligible for intensive chemotherapy due to age (≥75 years) or specified health conditions
- Projected life expectancy of at least 12 weeks
- White blood cell count less than 25 x 10⁹/L (hydroxyurea allowed to reduce count)
- Adequate kidney and liver function within defined limits
- Women of childbearing potential must use effective birth control and have negative pregnancy tests
- Men must use condoms and agree to avoid fathering a child during and after the study
- Able and willing to provide informed consent
You will not qualify if you...
- Prior treatment for AML, except hydroxyurea to control white blood cells
- Acute promyelocytic leukemia or AML with specific chromosomal abnormalities not allowed
- Significant active heart disease or severe lung disorders
- Recent stroke or intracranial hemorrhage within 6 months
- Active central nervous system leukemia
- Uncontrolled infections including hepatitis B, C, or HIV
- Life-threatening leukemia complications like uncontrolled bleeding
- Conditions limiting oral drug absorption
- Active second malignancy with some exceptions
- Recent live vaccine within 30 days or planned during the study
- Severe neurological or psychiatric disorders affecting consent
- Known allergy to anti-leukemic agents used
- Participation in other investigational drug studies
- Use of certain medications like Dabigatran or strong CYP3A4 inducers without proper management
- Pregnancy or breastfeeding
- Previously screened and found ineligible for this trial cannot re-enroll
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Continued until disease progression, unacceptable toxicity, death, withdrawal, or other protocol defined discontinuation criteria
Participants receive treatment with Revumenib or placebo in combination with Azacitidine and Venetoclax on a continuous 28-day cycle schedule.
28-day cycles with visits as scheduled by the study team
Trial Site Locations
Total: 67 locations
1
DE-Berlin-CAMPUSBENFRANKLIN
Berlin, Germany
Not Yet Recruiting
2
DE-Berlin-CAMPUSVIRCHOW
Berlin, Germany
Not Yet Recruiting
3
DE-Berlin-VIVANTESNEUKOLLN
Berlin, Germany
Not Yet Recruiting
4
DE-Bochum-RUB
Bochum, Germany
Not Yet Recruiting
5
DE-Bonn-UNIBONN
Bonn, Germany
Not Yet Recruiting
6
DE-Braunschweig-KLINIKUMBRAUNSCHWEIG
Braunschweig, Germany
Not Yet Recruiting
7
DE-Bremen-KBM
Bremen, Germany
Not Yet Recruiting
8
DE-Darmstadt-KLINIKUMDARMSTADT
Darmstadt, Germany
Not Yet Recruiting
9
DE-Essen-KEM
Essen, Germany
Not Yet Recruiting
10
DE-Flensburg-MALTESER
Flensburg, Germany
Not Yet Recruiting
11
DE-Frankfurt-KLINIKUMFRANKFURT
Frankfurt, Germany
Not Yet Recruiting
12
DE-Freiburg-UNIKLINIKFREIBURG
Freiburg im Breisgau, Germany
Not Yet Recruiting
13
DE-Greifswald-UNIGREIFSWALD
Greifswald, Germany
Not Yet Recruiting
14
DE-Hamburg-ASKLEPIOSSTGEORG
Hamburg, Germany
Not Yet Recruiting
15
DE-Hamburg-UKE
Hamburg, Germany
Not Yet Recruiting
16
DE-Hannover-MHHANNOVER
Hanover, Germany
Not Yet Recruiting
17
DE-Hannover-SILOAHKRH
Hanover, Germany
Not Yet Recruiting
18
DE-Heilbronn-SLK General Information
Heilbronn, Germany
Not Yet Recruiting
19
DE-Herne-MARIENHOSPITALHERNE
Herne, Germany
Not Yet Recruiting
20
DE-Karlsruhe-KLINIKUMKARLSRUHE
Karlsruhe, Germany
Not Yet Recruiting
21
DE-Mainz-UNIMEDIZINMAINZ
Mainz, Germany
Not Yet Recruiting
22
DE-Minden-MUEHLENKREISKLINKEN
Minden, Germany
Not Yet Recruiting
23
DE-München-IRZTUM
München, Germany
Not Yet Recruiting
24
DE-Oldenburg-KLINIKUMOLDENBURG
Oldenburg, Germany
Not Yet Recruiting
25
DE-Potsdam-BERGMANN
Potsdam, Germany
Not Yet Recruiting
26
DE-Stuttgart-KLINIKUMSTUTTGART
Stuttgart, Germany
Not Yet Recruiting
27
DE-Tübingen-MEDUNITUEBINGEN
Tübingen, Germany
Not Yet Recruiting
28
DE-Ulm-UNIKLINKULM
Ulm, Germany
Not Yet Recruiting
29
DE-Wuppertal-HELIOSGESUNDHEIT
Wuppertal, Germany
Not Yet Recruiting
30
NL-Den Bosch-JBZ
's-Hertogenbosch, Netherlands
Not Yet Recruiting
31
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
Not Yet Recruiting
32
NL-Amsterdam-OLVG
Amsterdam, Netherlands
Not Yet Recruiting
33
NL-Amsterdam-VUMC
Amsterdam, Netherlands
Not Yet Recruiting
34
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
Not Yet Recruiting
35
NL-Breda-AMPHIA
Breda, Netherlands
Not Yet Recruiting
36
NL-Delft-RDGG
Delft, Netherlands
Not Yet Recruiting
37
NL-Eindhoven-MAXIMAMC
Eindhoven, Netherlands
Not Yet Recruiting
38
NL-Enschede-MST
Enschede, Netherlands
Not Yet Recruiting
39
NL-Goes-ADRZ
Goes, Netherlands
Not Yet Recruiting
40
NL-Groningen-UMCG
Groningen, Netherlands
Actively Recruiting
41
NL-Leeuwarden-MCL
Leeuwarden, Netherlands
Not Yet Recruiting
42
NL-Leiden-LUMC
Leiden, Netherlands
Not Yet Recruiting
43
NL-Maastricht-MUMC
Maastricht, Netherlands
Not Yet Recruiting
44
NL-Nieuwegein-ANTONIUS
Nieuwegein, Netherlands
Not Yet Recruiting
45
NL-Nijmegen-RADBOUDUMC
Nijmegen, Netherlands
Not Yet Recruiting
46
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
Not Yet Recruiting
47
NL-Den Haag-HAGA
The Hague, Netherlands
Not Yet Recruiting
48
NL-Utrecht-UMCUTRECHT
Utrecht, Netherlands
Not Yet Recruiting
49
NL-Zwolle-ISALA
Zwolle, Netherlands
Not Yet Recruiting
50
Belfasttrust
Belfast, United Kingdom
Not Yet Recruiting
51
Birmingham-QE
Birmingham, United Kingdom
Not Yet Recruiting
52
Blackpool Victoria
Blackpool, United Kingdom
Not Yet Recruiting
53
UH Bristol
Bristol, United Kingdom
Not Yet Recruiting
54
University Hospital of Wales
Cardiff, United Kingdom
Not Yet Recruiting
55
Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Not Yet Recruiting
56
St. James UH
Leeds, United Kingdom
Not Yet Recruiting
57
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom
Not Yet Recruiting
58
University of Liverpool
Liverpool, United Kingdom
Not Yet Recruiting
59
King's College Hospital
London, United Kingdom
Not Yet Recruiting
60
St Bartholomew's Hospital
London, United Kingdom
Not Yet Recruiting
61
Christie NHS Foundation Trust
Manchester, United Kingdom
Not Yet Recruiting
62
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle, United Kingdom
Not Yet Recruiting
63
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Not Yet Recruiting
64
Churchill Hospital, Oxford
Oxford, United Kingdom
Not Yet Recruiting
65
Southampton General Hospital
Southampton, United Kingdom
Not Yet Recruiting
66
The Royal Marsden NHSFT
Sutton, United Kingdom
Not Yet Recruiting
67
New cross hospital wolverhampton
Wolverhampton, United Kingdom
Not Yet Recruiting
Research Team
G
Gerwin Huls, MD
P
Paresh Vyas, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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