Actively Recruiting
A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML
Led by Stichting Hemato-Oncologie voor Volwassenen Nederland · Updated on 2024-01-18
142
Participants Needed
18
Research Sites
215 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The treatment of older unfit patients with acute myeloid leukemia (AML) is challenging. The hypomethylating agents (HMA) azacitidine and decitabine have relatively mild side effects and have proven to be feasible for the treatment of older patients and patients with co-morbidities. Currently, venetoclax added to an HMA agent is the new standard of treatment. Since this new standard comes with a substantial societal financial burden, there is a rational to optimize the venetoclax dosing schedule. The CYP3A4 inhibitor cobicistat (COBI) can be used to increase venetoclax exposure, thereby allowing to reduce the dose of venetoclax and thus costs substantially.
CONDITIONS
Official Title
A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of AML or related precursor neoplasms based on ICC-2022 classification, excluding acute promyelocytic leukemia
- Age 18 years or older and not fit for or declining intensive chemotherapy
- WHO performance status of 0, 1, or 2
- Adequate kidney function with creatinine clearance ≥ 30 mL/min
- Serum bilirubin ≤ 3 times upper limit of normal unless AML-related or due to Gilbert's syndrome
- Alanine transaminase (ALT) ≤ 3 times upper limit of normal unless AML-related
- Male participants who agree to use protocol-specified contraception from study day 1 until 90 days after last dose and refrain from sperm donation during this period
- Female participants who are postmenopausal (age >55 years with no menses for at least 12 months) or willing and able to use adequate contraception during and until 180 days after last treatment
- Ability to provide informed consent
- Agreement not to participate in another interventional study while on treatment without approval
You will not qualify if you...
- Diagnosis of acute promyelocytic leukemia
- Diagnosis of myelodysplastic syndrome (MDS)
- Prior treatment for AML or MDS except erythropoiesis stimulating agents or hydroxyurea
- Previous or concurrent malignancy unless treated curatively at least 24 months ago, excluding certain skin and cervical cancers
- Blast crisis of chronic myeloid leukemia
- Severe or uncontrolled medical conditions such as uncontrolled diabetes, infections, hypertension, or lung disease
- Recent myocardial infarction within 3 months or significant heart dysfunction
- Unstable angina, severe congestive heart failure, or unstable cardiac arrhythmias
- History of stroke or brain bleeding within 6 months
- Symptomatic central nervous system leukemia
- History of non-compliance or unreliable adherence to medical treatments
- Dementia, mental impairment, or psychiatric disorders preventing informed consent
- Current chemotherapy, radiation, or immunotherapy other than hydroxyurea
- Conditions impairing compliance with the study protocol
- Use of strong CYP3A inhibitors or inducers or certain drugs that interact with study medications
- Allergy or intolerance to study drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 18 locations
1
NL-Amersfoort-MEANDERMC
Amersfoort, Netherlands
Not Yet Recruiting
2
NL-Amsterdam-OLVG
Amsterdam, Netherlands
Not Yet Recruiting
3
NL-Amsterdam-VUMC
Amsterdam, Netherlands
Not Yet Recruiting
4
NL-Arnhem-RIJNSTATE
Arnhem, Netherlands
Not Yet Recruiting
5
NL-Breda-AMPHIA
Breda, Netherlands
Not Yet Recruiting
6
NL-Dordrecht-ASZ
Dordrecht, Netherlands
Not Yet Recruiting
7
NL-Eindhoven-CATHARINA
Eindhoven, Netherlands
Not Yet Recruiting
8
NL-Eindhoven-MAXIMAMC
Eindhoven, Netherlands
Not Yet Recruiting
9
NL-Enschede-MST
Enschede, Netherlands
Not Yet Recruiting
10
NL-Groningen-UMCG
Groningen, Netherlands
Actively Recruiting
11
NL-Leeuwarden-MCL
Leeuwarden, Netherlands
Not Yet Recruiting
12
NL-Leiden-LUMC
Leiden, Netherlands
Not Yet Recruiting
13
NL-Maastricht-MUMC
Maastricht, Netherlands
Not Yet Recruiting
14
NL-Nieuwegein-ANTONIUS
Nieuwegein, Netherlands
Not Yet Recruiting
15
NL-Nijmegen-CWZ
Nijmegen, Netherlands
Not Yet Recruiting
16
NL-Rotterdam-ERASMUSMC
Rotterdam, Netherlands
Not Yet Recruiting
17
NL-Den Haag-HAGA
The Hague, Netherlands
Not Yet Recruiting
18
NL-Zwolle-ISALA
Zwolle, Netherlands
Not Yet Recruiting
Research Team
G
Gerwin Huls, prof
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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