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Study on Cobicistat, Venetoclax, and Azacitidine for Patients with Newly Diagnosed Acute Myeloid Leukemia Ineligible for Intensive Chemotherapy

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What is this study about?

This clinical trial is focused on studying a type of blood cancer called Acute Myeloid Leukemia (AML). The study is investigating the effects of a combination of medications: cobicistat, venetoclax, and azacitidine. These medications are being tested together to see if they can help patients who have been newly diagnosed with AML and are not suitable for intensive chemotherapy treatments.

The purpose of the study is to understand how well this combination of medications works in improving the survival of patients with AML. The study will begin with a phase where the effects of adding cobicistat to venetoclax are observed. This is followed by a longer phase where the combination of cobicistat, venetoclax, and azacitidine is given to patients to assess its overall impact on their health. The study will last for a period of up to two years, during which patients will receive these medications and be monitored for their response to the treatment.

Participants in the study will receive the medications in different forms: azacitidine as a powder for injection, venetoclax as a film-coated tablet, and cobicistat as a tablet. The medications will be administered either orally or through injections, depending on the specific drug. The study aims to provide valuable insights into the potential benefits of this treatment combination for patients with AML who cannot undergo more aggressive chemotherapy options.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s objectives and procedures. Written informed consent is required to participate.

2 run-in phase

The initial phase involves evaluating the pharmacokinetic equivalence of cobicistat-boosted venetoclax compared to unboosted venetoclax. This means assessing how the body absorbs, distributes, and eliminates the medication.

During this phase, the patient will receive venetoclax and cobicistat orally. The specific dosage and frequency will be determined by the study protocol.

3 extension phase

In this phase, the patient will receive a combination of azacitidine, venetoclax, and cobicistat. Azacitidine is administered subcutaneously or intravenously, while venetoclax and cobicistat are taken orally.

The goal is to assess the practical applicability and therapeutic effect of this combination on overall survival in patients with acute myeloid leukemia (AML).

4 medication schedule

Azacitidine is given through subcutaneous or intravenous routes. The specific dosage and schedule will be provided by the healthcare team.

Venetoclax and cobicistat are taken orally. The dosage and frequency will be adjusted according to the study protocol.

5 monitoring and assessments

Throughout the trial, regular monitoring and assessments will be conducted to evaluate the patient’s response to the treatment and any side effects.

These assessments may include blood tests, imaging studies, and other evaluations as deemed necessary by the healthcare team.

6 completion of the trial

The trial is expected to continue until December 31, 2027. Upon completion, the patient’s overall health and response to the treatment will be reviewed.

Further follow-up may be required to monitor long-term outcomes and any potential late effects of the treatment.

Who Can Join the Study?

  • Patients must have a diagnosis of Acute Myeloid Leukaemia (AML), which is a type of blood cancer, according to a specific classification. This does not include a type called acute promyelocytic leukaemia.
  • Patients may have had previous treatment with erythropoiesis stimulating agents (ESA), which are medicines that help the body make more red blood cells, for a previous condition called myelodysplastic syndromes (MDS). These medicines must be stopped at least two weeks before joining the study.
  • Patients must be 18 years or older and considered not suitable for intensive chemotherapy, as judged by their doctor, or they must choose not to have intensive chemotherapy.
  • Patients must have a WHO performance status of 0, 1, or 2, which is a way to measure how well they can perform daily activities.
  • Patients must have adequate kidney and liver function, unless the disease affects these organs. This is shown by certain lab tests: a creatinine clearance of at least 30 mL/min, which measures kidney function, and specific levels of liver enzymes and bilirubin, which measure liver function.
  • Male patients who are sexually active must agree to use contraception from the first day of the study until at least 90 days after the last dose of the study drug. They must also agree not to donate sperm during this time.
  • Female patients must either be postmenopausal, meaning they are over 55 years old and have not had a menstrual period for at least 12 months without another medical reason, or they must agree to use adequate contraception during the study and until 180 days after the last treatment.
  • Patients must provide written informed consent, which means they understand the study and agree to participate.
  • Patients must be capable of giving informed consent, meaning they can understand the information about the study and make a decision to participate.
  • Patients must agree not to participate in another interventional study while receiving treatment in this study, unless approved by the study’s main investigator.

Who Cannot Join the Study?

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
University Hospital Maastricht Maastricht The Netherlands

Other Sites

Site Name City Country Status
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Medisch Centrum Leeuwarden B.V. Leeuwarden The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Haga Hospital Hague The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Canisius Wilhelmina Ziekenhuis Nijmegen The Netherlands
Amphia Hospital Breda The Netherlands
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Maxima Medisch Centrum Veldhoven The Netherlands
Ahuixjpwa Uaw Amsterdam The Netherlands
Luvui Ugbozrhyasdq Mobgfhr Cojrjqj (dszpu Leiden The Netherlands
Rxavmphkd Zgxobwyzsa Scygoguya Arnhem The Netherlands
Uycaodreaaan Mnsyyjp Crlasch Gtubjlxnz Groningen The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
29.12.2023

Trial locations

Investigated drugs:

Venetoclax is a medication used in this trial to help treat acute myeloid leukemia (AML). It works by targeting and blocking a specific protein in cancer cells, which can help to stop the growth of these cells and lead to their death. In this study, venetoclax is being tested both with and without a booster to see how it affects the body and its effectiveness in treating AML.

Cobicistat is used in this trial as a booster for venetoclax. Its role is to enhance the effects of venetoclax by increasing its levels in the body, which may improve its ability to fight cancer cells. The study is examining how well cobicistat can boost venetoclax and whether this combination is more effective than using venetoclax alone.

Azacitidine is another medication included in this trial. It is used to treat AML by interfering with the growth of cancer cells, which can help to slow down or stop the progression of the disease. In this study, azacitidine is combined with venetoclax and cobicistat to see if this combination can improve treatment outcomes for patients who are not candidates for intensive chemotherapy.

Investigated diseases:

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that starts in the bone marrow, where blood cells are made, and quickly moves into the blood. It affects a group of white blood cells called myeloid cells, which normally develop into various types of mature blood cells. In AML, these cells do not mature properly and multiply rapidly, leading to a buildup of abnormal cells that can crowd out healthy blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses quickly and requires prompt medical attention to manage the overproduction of immature cells. AML is more common in adults and can vary in its specific characteristics and progression based on genetic factors.

Trial ID:
2023-505379-61-00
Protocol code:
HO171
NCT ID:
NCT06014489
Trial Phase:
Therapeutic exploratory (Phase II)

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