Actively Recruiting
Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML
Led by Technische Universität Dresden · Updated on 2024-12-02
146
Participants Needed
18
Research Sites
229 weeks
Total Duration
On this page
Sponsors
T
Technische Universität Dresden
Lead Sponsor
U
University Hospital Heidelberg
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase II clinical trial evaluates the efficacy and tolerability of the non-intensive treatment with venetoclax and the hypomethylating agent azacitidine as compared to the standard of care chemotherapy plus gemtuzumab ozogamicin in newly diagnosed NPM1 mutated AML patients fit for intensive chemotherapy.
CONDITIONS
Official Title
Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent
- Newly diagnosed CD33-positive AML with NPM1 mutation according to WHO criteria
- Age between 18 and 70 years
- Fit for intensive chemotherapy with ECOG performance status 0-2
- Adequate liver function (ALAT/ASAT/Bilirubin 2.5 times upper limit of normal, except as noted for Gilbert's Syndrome)
- Adequate kidney function (serum creatinine 1.5 times upper limit of normal or creatinine clearance 50 mL/min)
- White blood cell count less than 25,000/L; hydroxyurea allowed to meet this
- Ability and willingness to sign informed consent
- Male participants must agree to avoid unprotected sex and sperm donation from consent until 7 months after last study drug dose
- Women of childbearing potential must have a negative pregnancy test within 72 hours before first study drug dose
You will not qualify if you...
- Presence of activating FLT3 mutation
- Relapsed or refractory AML
- AML after prior myelodysplastic syndrome treated with cytotoxic therapy
- Previous malignancy unless disease-free for at least 1 year, with some exceptions
- Prior treatment with hypomethylating agents or venetoclax
- Previous AML treatment except hydroxyurea
- Cumulative anthracycline dose over 200 mg/m2 doxorubicin equivalents
- Central nervous system involvement or only extramedullary disease
- Known allergies to study drugs or their components
- HIV infection or active/chronic hepatitis without viral clearance
- Inability to swallow oral medication
- Malabsorption conditions
- NYHA Class 2 or higher heart failure, unstable coronary artery disease, or serious ventricular arrhythmias
- Chronic respiratory disease requiring continuous oxygen
- Substance abuse or conditions interfering with study participation
- Concurrent participation in another interventional clinical trial
- Pregnant or breastfeeding women
- Unwillingness to follow strict contraception requirements unless post-menopausal or surgically sterile
- History of significant liver cirrhosis (Child-Pugh B or C)
- Live-virus vaccination within 28 days before study treatment (excluding COVID-19 vaccines)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
Universitätsklinikum Essen
Essen, North Rhine-Westphalia, Germany, 45147
Actively Recruiting
2
Universitätsklinikum Aachen
Aachen, Germany, 52074
Actively Recruiting
3
Universitätsklinikum Augsburg
Augsburg, Germany, 86156
Actively Recruiting
4
Klinikum Chemnitz gGmbH
Chemnitz, Germany, 09116
Actively Recruiting
5
Universiätsklinikum Köln
Cologne, Germany, 50937
Not Yet Recruiting
6
Universitätsklinikum Dresden
Dresden, Germany, 01307
Actively Recruiting
7
Universitätsklinikum Erlangen
Erlangen, Germany, 91054
Actively Recruiting
8
Johann Wolfgang Goethe-Universität
Frankfurt am Main, Germany, 60590
Actively Recruiting
9
Universitätsklinikum Halle
Halle, Germany, 06120
Actively Recruiting
10
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Actively Recruiting
11
Universitätsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Actively Recruiting
12
Universitätsklinikum Leipzig
Leipzig, Germany, 04103
Actively Recruiting
13
Klinikum Mannheim gGmbH
Mannheim, Germany, 68167
Actively Recruiting
14
Philipps-Universität Marburg Fachbereich Medizin
Marburg, Germany, 35043
Actively Recruiting
15
Universitätsklinikum Münster
Münster, Germany, 48149
Actively Recruiting
16
Klinikum Nürnberg-Nord
Nuremberg, Germany, 90419
Actively Recruiting
17
Krankenhaus Barmherzige Brüder
Regensburg, Germany, 93049
Actively Recruiting
18
Robert-Bosch-Krankenhaus
Stuttgart, Germany, 70376
Actively Recruiting
Research Team
M
Manja Reimann, Dr.
CONTACT
F
Frank Fiebig
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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