Study on the Safety of Low-Dose Cytarabine or Azacitidine with Venetoclax and Quizartinib for Acute Myeloid Leukemia in Patients Aged 60+ Ineligible for Standard 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 specifically for patients who are newly diagnosed with AML, are 60 years or older, and are not eligible for the usual intensive chemotherapy treatment. The trial will explore the safety and how well patients tolerate a combination of medications, including Venetoclax (also known by its code names ABT-199 and GDC-0199), Quizartinib Dihydrochloride, and either low-dose Cytarabine or Azacitidine. These medications are taken orally in the form of tablets.

The purpose of the study is to find the best dose of these medications when used together and to see how effective they are in treating AML. The trial will be conducted in two phases. In the first phase, researchers will determine the recommended dose for the second phase. In the second phase, they will assess how well the treatment works by looking at the rate of complete or partial remission, which means the cancer is reduced or disappears. Participants will receive the treatment over several cycles, and their overall health and quality of life will be monitored throughout the study.

Participants will be closely observed for any side effects or reactions to the treatment. The study will also look at how long patients live without the disease getting worse and how long they remain free of the disease after treatment. Additionally, researchers will explore various biological markers that might predict how well the treatment works and how long the response lasts. The trial aims to provide valuable information that could lead to better treatment options for older patients with AML who cannot undergo standard chemotherapy.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and current health status to ensure the patient meets the criteria for participation.

2 treatment phase I

The first phase of treatment involves determining the appropriate dosage of the medications. This phase is focused on establishing the recommended dose for the next phase of the trial.

Medications include venetoclax and quizartinib dihydrochloride, both administered orally. The specific dosage and schedule are adjusted based on individual response and tolerance.

3 treatment phase II

In the second phase, the effectiveness of the treatment is evaluated. This involves monitoring the patient’s response to the combination of medications.

The goal is to assess the rate of complete response or partial response to the treatment regimen, which includes venetoclax and quizartinib dihydrochloride.

4 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to track the patient’s health and any side effects. This includes blood tests and other assessments to ensure safety and effectiveness.

Follow-up visits are scheduled to evaluate the long-term impact of the treatment and to gather data on overall survival and quality of life.

5 completion of trial

Upon completion of the trial, a final assessment is conducted. This includes a comprehensive review of the patient’s response to the treatment and any lasting effects.

The data collected during the trial contributes to understanding the safety and effectiveness of the treatment for future patients.

Who Can Join the Study?

Patients must have been newly diagnosed with acute myeloid leukemia (AML), a type of blood cancer.
Patients must have a morphological diagnosis of AML, which means the diagnosis is based on the appearance of cells under a microscope.
Patients must be considered ineligible for standard treatment with certain chemotherapy drugs due to age or other health conditions. This includes:

Being 71 years of age or older.
Being between 60 to 70 years of age with at least one of the following health issues:

ECOG Performance Status of 2 or 3, which is a scale used to assess how a disease affects a patient’s daily living abilities.
Heart problems like congestive heart failure (CHF) needing treatment, or a heart ejection fraction of 55% or less, or stable chest pain (angina).
Lung function tests showing DLCO or FEV1 of 65% or less, or a significant history of chronic lung disease.
Kidney function with creatinine clearance between 30 to less than 50 mL/min.
Moderate liver problems with certain liver tests being higher than normal but not more than three times the upper limit.
Having a previous cancer that is not active or is controlled.
Any other health condition that the doctor believes makes intensive chemotherapy unsuitable, which must be approved by the trial coordinators.

Patients must have an ECOG performance status of 3 or less.
Male patients who are sexually active must agree to use specific birth control methods from the start of the study until 120 days after the last dose of the study drug.
Female patients must meet one of the following conditions:

Be postmenopausal for at least one year before screening.
Be permanently surgically sterile (e.g., removal of ovaries, fallopian tubes, or uterus).
If of childbearing potential, agree to use one highly effective and one additional effective method of birth control at the same time, from signing the consent through four months after the last dose of the study drug.
Agree to practice true abstinence if it aligns with their lifestyle.
Have a negative pregnancy test and not be breastfeeding.

Patients must voluntarily sign and date an informed consent form approved by an Independent Ethics Committee before any study procedures begin, understanding they can withdraw consent at any time without affecting future medical care.

Who Cannot Join the Study?

Patients who have been diagnosed with a different type of leukemia or cancer.
Patients who have received treatment for leukemia before.
Patients with severe heart problems.
Patients with uncontrolled infections.
Patients with severe liver or kidney disease.
Patients who are pregnant or breastfeeding.
Patients who are unable to follow the study procedures.
Patients who are participating in another clinical trial.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario Y Politecnico La Fe	Valencia	Spain

Other Sites

Site Name	City	Country
Hospital San Pedro De Alcantara	Caceres	Spain
Hospital Clinic De Barcelona	Barcelona	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Hqucrtgx Ugpsudtyrpvgs Mmonw Tgbmkdlf	Terrassa	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	09.11.2020

Trial locations

Investigated drugs:

Cytarabine is a medication used in the treatment of certain types of leukemia. In this trial, it is used in a low-dose form to help treat newly diagnosed acute myeloid leukemia in older patients who cannot undergo standard chemotherapy.

Azacitidine is another medication used to treat certain blood disorders and types of leukemia. In this trial, it is combined with other drugs to help manage acute myeloid leukemia in patients who are not eligible for standard chemotherapy.

Venetoclax is a medication that helps to kill cancer cells by targeting a specific protein that helps them survive. It is used in combination with other drugs in this trial to treat acute myeloid leukemia.

Quizartinib is an investigational drug that targets specific proteins involved in the growth of cancer cells. In this trial, it is used alongside other medications to treat acute myeloid leukemia in older patients.

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that starts in the blood-forming cells of the bone marrow and quickly progresses to affect the blood. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. AML can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. The disease is more common in older adults, particularly those aged 60 and above. As AML progresses, it can spread to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. The progression of AML can vary, with some cases advancing rapidly while others may progress more slowly.

Trial ID:

2024-519275-26-00

Protocol code:

VEN-A-QUI

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety of Low-Dose Cytarabine or Azacitidine with Venetoclax and Quizartinib for Acute Myeloid Leukemia in Patients Aged 60+ Ineligible for Standard Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?