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New treatment option for AML, Adult
Official title A Trial to Assess Cobicistat Boosted Venetoclax in Combination With Azacitidine in Adult Patients With Newly Diagnosed AML
ClinicalTrials.gov ID: NCT06014489
What this study is testing
What is azacitidine?
azacitidine is an investigational medicine, being studied as a potential treatment for aml, adult.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia)...
- Patients 18 years and older who are considered not fit for intensive chemotherapy or who decline the option of intensive chemotherapy.
- WHO performance status 0, 1 or 2 (appendix E).
- Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
You likely can't join if
- A patient who meets any of the following criteria cannot be included in this study:
- Acute promyelocytic leukemia.
- Myelodysplastic syndrome (MDS).
- Patients previously treated for AML or MDS (any anti-leukemic therapy including investigational agents; excluding: 1) erythropoiesis stimulating...
- Diagnosis of any previous or concomitant malignancy is an exclusion criterion:
- except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy...
See the full eligibility criteria
- In order to be eligible to participate in this study, a patient must meet all of the following criteria:
- Patients with: a diagnosis of AML and related precursor neoplasms according to ICC-2022 classification (excluding acute promyelocytic leukaemia) (appendix A). Patients may have had previous treatment with erythropoiesis...
- Patients 18 years and older who are considered not fit for intensive chemotherapy or who decline the option of intensive chemotherapy.
- WHO performance status 0, 1 or 2 (appendix E).
- Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values:
- Adequate renal function as demonstrated by a creatinine clearance ≥ 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24 hours urine collection.
- Serum bilirubin ≤ 3 x upper limit of normal (ULN), unless considered AML-related or due to Gilbert's syndrome.
- Alanine transaminase (ALT) ≤ 3 x ULN, unless considered AML-related.
- Male people who are sexually active, must agree, from Study Day 1 until at least 90 days after the last dose of study drug, to practice the protocol specified contraception. Male people must agree to refrain from sperm...
- Female people must be either postmenopausal defined as: Age \>55 years with no menses for ≥12 months, without an alternative medical cause. OR willing and able to use adequate contraception during and until 180 days...
- Written informed consent.
- Patient is capable of giving informed consent.
- Patient agrees not to participate in another treatment study while on treatment without approval of the (co-) Principal Investigator.
- A patient who meets any of the following criteria cannot be included in this study:
- Acute promyelocytic leukemia.
- Myelodysplastic syndrome (MDS).
- Patients previously treated for AML or MDS (any anti-leukemic therapy including investigational agents; excluding: 1) erythropoiesis stimulating agents (ESAs); 2) hydroxyurea (hydroxyurea is allowed for the control of...
- Diagnosis of any previous or concomitant malignancy is an exclusion criterion:
- except when the patient successfully completed treatment (chemotherapy and/or surgery and/or radiotherapy) with curative intent for this malignancy at least 24 months prior to registration;
- except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix.
- Blast crisis of chronic myeloid leukemia.
- Concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes, infection, hypertension, pulmonary disease etc.).
- Cardiac dysfunction as defined by:
- Myocardial infarction within the last 3 months of study entry, or
- Reduced left ventricular function with an ejection fraction \< 40% as measured by MUGA scan or echocardiogram, or
- Unstable angina or New York Heart Association (NYHA) grade IV congestive heart failure (see Appendix G), or
- Unstable cardiac arrhythmias.
- History of stroke or intracranial haemorrhage within 6 months prior to registration.
- Symptomatic central nervous system (CNS) leukemia (NO routinely lumbar puncture required to investigate CNS involvement).
- History of non-compliance to medical regimens or considered unreliable with respect to compliance.
- Senile dementia, mental impairment or any other psychiatric disorder that prohibits the patient from understanding and giving informed consent.
- Current concomitant chemotherapy, radiation therapy, or immunotherapy; other than hydroxyurea.
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
- Unreplaceable use of strong inhibitors or inducers of CYP3A or CYP3A/p-GP substrates with a narrow therapeutic window (e.g. cobicistat or ritonavir for HIV treatment). Please check with Appendix I.
- Intolerability, contra-indication or allergy to one of the study drugs.
The study team makes the final eligibility decision.
Where it's taking place
- Amersfoort, Netherlands
- Amsterdam, Netherlands
- Arnhem, Netherlands
- Breda, Netherlands
- Dordrecht, Netherlands
- Eindhoven, Netherlands
- Enschede, Netherlands
- Groningen, Netherlands
- Leeuwarden, Netherlands
- Leiden, Netherlands
- Maastricht, Netherlands
- Nieuwegein, Netherlands
- Nijmegen, Netherlands
- Rotterdam, Netherlands
- The Hague, Netherlands
- Zwolle, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Amersfoort, Netherlands; Amsterdam, Netherlands; Arnhem, Netherlands; Breda, Netherlands; Dordrecht, Netherlands; Eindhoven, Netherlands and 10 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.