Not recruiting

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

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

21 criteria

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 trial?

8 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital Universitario Mutua Terrassa
Verified
Terrassa, Spain
Hospital Universitario Y Politecnico La Fe
Verified
Valencia, Spain

Trial locations

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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.

What is already known about the treatment

Cytarabine
Cytarabine is administered as an injection, typically given intravenously. It is currently used in clinical trials to treat acute myeloid leukemia, particularly in patients aged 60 and older who are not eligible for standard chemotherapy. The medication works by interfering with the DNA synthesis of cancer cells, preventing their growth and division. It is classified as an antimetabolite, a type of chemotherapy drug.
Azacitidine
Azacitidine is administered via injection, either subcutaneously or intravenously. It is being studied in clinical trials for its effectiveness in treating acute myeloid leukemia in older patients. Azacitidine works by incorporating into the DNA and RNA of cancer cells, disrupting their function and leading to cell death. It is classified as a nucleoside metabolic inhibitor.
Venetoclax
Venetoclax is taken orally in tablet form. It is part of ongoing clinical trials for treating acute myeloid leukemia in patients who cannot undergo standard chemotherapy. Venetoclax targets and inhibits a protein called BCL-2, which helps cancer cells survive, thereby promoting their death. It is classified as a BCL-2 inhibitor.
Quizartinib
Quizartinib is administered orally in capsule form. It is being evaluated in clinical trials for its potential to treat acute myeloid leukemia in older patients. Quizartinib works by inhibiting a specific enzyme called FLT3, which is involved in the growth and survival of cancer cells. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

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.