Study on Personalized Treatment for Acute Myeloid Leukemia Using Cladribine, Daunorubicin, Cytarabine, and Drug Combinations for Specific Patient Groups

3 1 1

What is this study about?

This clinical trial is focused on studying Acute Myeloid Leukemia (AML), a type of cancer that affects the blood and bone marrow. The study aims to explore the effectiveness of different treatment combinations for patients with AML. The treatments being tested include a combination of medications such as Cladribine, Daunorubicin, Cytarabine (also known as cytosine arabinoside), Gemtuzumab Ozogamicin, Midostaurin, and Venetoclax. These medications are used to target and kill cancer cells in the body.

The purpose of the study is to compare the effectiveness of these treatment combinations in improving the condition of patients with AML. The study will involve different groups of patients receiving different combinations of these medications. For example, one group will receive Cladribine with Daunorubicin, Cytarabine, and Gemtuzumab Ozogamicin, while another group will receive Cladribine with Daunorubicin, Cytarabine, and Midostaurin. Another group will receive Venetoclax with Cladribine, Daunorubicin, and Cytarabine. Some patients may receive a placebo as part of the study.

Participants in the study will receive their assigned treatment over a period of time, and their health will be monitored to assess the effectiveness of the treatment. The study will help determine which combination of medications works best for different types of AML patients, including those with specific genetic mutations like the FLT3 gene mutation. The results of this study could lead to more personalized and effective treatment strategies for patients with AML.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age, general health condition, and diagnosis of acute myeloid leukemia.

Consent is required to participate, including agreement to use effective contraception during the study.

2 treatment assignment

Participants are assigned to different treatment groups based on specific genetic markers and health conditions.

The treatment protocols include combinations of medications such as cladribine, daunorubicin, cytarabine, midostaurin, venetoclax, and gemtuzumab ozogamicin.

3 induction treatment

The induction treatment phase involves receiving specific drug combinations intravenously or orally, depending on the assigned protocol.

For example, the DAC+GO protocol includes cladribine, daunorubicin, cytarabine, and gemtuzumab ozogamicin for certain patients.

4 monitoring and assessments

Regular monitoring and assessments are conducted to evaluate the effectiveness of the treatment.

Event-free survival and other health outcomes are measured to determine the success of the treatment.

5 completion of treatment

The study is expected to continue until November 2027, with ongoing assessments and follow-ups.

Participants may undergo additional treatments or procedures based on their response to the initial treatment.

Who Can Join the Study?

Must have been diagnosed with Acute Myeloid Leukemia according to the WHO 2016 criteria. This is a type of blood cancer.
Must be between the ages of 18 and 65 years old.
Must have a general health condition score of 2 or less on the ECOG scale. This scale measures how well you can perform daily activities.
Must have a score of 3 or less on the HCT-CI comorbidity index. This index assesses other health conditions you might have.
Must provide informed, written consent to participate in the study.
Must agree to use effective contraception during the study. This applies to both women and men.
Women of childbearing age must have a negative pregnancy test, either from blood (serum) or urine.

Who Cannot Join the Study?

Patients who are not diagnosed with Acute Myeloid Leukemia (AML). AML is a type of cancer that affects the blood and bone marrow.
Patients who are not within the specified age range for the study. The study is open to certain age groups only.
Patients who do not meet the specific genetic criteria required for the study. This may include certain gene mutations related to AML.
Patients who are not able to follow the study protocol or procedures. This means they must be able to attend all required appointments and follow instructions.
Patients who have other medical conditions that could interfere with the study. This includes conditions that might affect the safety or effectiveness of the treatment being tested.
Patients who are pregnant or breastfeeding. This is to ensure the safety of both the mother and the baby.
Patients who are participating in another clinical trial. Being in more than one study at a time can affect the results and safety.
Patients who have had certain treatments recently that could interfere with the study. This includes specific medications or therapies.
Patients who have allergies or reactions to the study medications. This is to prevent any harmful side effects.
Patients who are unable to give informed consent. This means they must understand the study and agree to participate willingly.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Uniwersytecki Szpital Kliniczny Im Jana Mikulicza Radeckiego We Wroclawiu	Wroclaw	Poland
Osrodek Badan Klinicznych Przy Szpitalu Specjalistycznym Im. Ludwika Rydygiera W Krakowie Sp. z o.o.	Cracow	Poland
Pomeranian Medical University	Szczecin	Poland

Other Sites

Site Name	City	Country
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Zespol Szpitali Miejskich	Chorzow	Poland
Szpital Specjalistyczny W Brzozowie Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza	Brzozow	Poland
Szpital Uniwersytecki Nr 2 Im Dr Jana Biziela W Bydgoszczy	Bydgoszcz	Poland
Uniwersytecki Szpital Kliniczny W Bialymstoku	Bialystok	Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie	Cracow	Poland
Samodzielny Publiczny Szpital Kliniczny Nr 1 W Lublinie	Lublin	Poland
Uniwersytecki Szpital Kliniczny W Poznaniu	Poznan	Poland
Instytut Hematologii I Transfuzjologii	Warsaw	Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego	Warsaw	Poland
Szpital Kliniczny Ministerstwa Spraw Wewnetrznych I Administracji Z Warminsko-Mazurskim Centrum Onkologii W Olsztynie	Olsztyn	Poland
Wojewodzki Szpital Zespolony Im.L.Rydygiera W Toruniu	Torun	Poland
Uoaomlwqosicfn Crkyjpz Ktzjaabyb	Gdansk	Poland
Wglbmrpsdpa Wokwvztugthavvasxhsu Cmhicnd Osoidxwxl I Tvmwilpibsjug In Mlvvnygxzuz W Lccuz	Lodz	Poland
Smdhgixb Pxjgwmfkh Sco z oqft	Gdynia	Poland
Skukrjmefya Prmifdchb Siqncyf Ksptitwqg Iookccnkuhs Mabhoyqessb Sxr W Kyrtsprurd	Katowice	Poland

Trial status

Country	Status	Recruitment Start
Poland	Recruiting	01.03.2024

Trial locations

Investigated drugs:

Cladribine is a medication used in this trial as part of different treatment combinations for patients with acute myeloid leukemia (AML). It is included in protocols to help improve the effectiveness of the treatment by targeting cancer cells.

Daunorubicin is a chemotherapy drug that is used in combination with other medications in this trial. It works by slowing or stopping the growth of cancer cells.

Cytosine Arabinoside, also known as cytarabine, is another chemotherapy medication used in the trial. It helps to kill cancer cells and is a key part of the treatment combinations being tested.

Gemtuzumab Ozogamicin is an antibody-drug conjugate used in one of the treatment protocols for patients with a specific type of AML. It targets cancer cells and delivers a toxic substance to help destroy them.

Midostaurin is a medication used in the trial for patients with AML who have certain genetic mutations. It works by inhibiting specific proteins that promote cancer cell growth.

Venetoclax is included in one of the treatment combinations for AML patients. It helps to induce cancer cell death by targeting proteins that allow cancer cells to survive.

Investigated diseases:

Acute myeloid leukaemia

Acute Myeloid Leukemia – Acute Myeloid Leukemia (AML) is a type of cancer that affects the blood and bone marrow, characterized by the rapid growth of abnormal white blood cells. These abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. As the disease progresses, it can lead to symptoms such as fatigue, frequent infections, and easy bruising or bleeding due to the lack of healthy blood cells. AML can occur at any age but is more common in adults. The disease is classified into different subtypes based on genetic and chromosomal abnormalities. The progression of AML can vary, with some cases advancing quickly while others may develop more slowly.

Trial ID:

2023-503394-37-00

Protocol code:

020520

Trial Phase:

Therapeutic confirmatory (Phase III)

Other Trials to Consider

#1 Clinical Trials Search in Europe

Study on Personalized Treatment for Acute Myeloid Leukemia Using Cladribine, Daunorubicin, Cytarabine, and Drug Combinations for Specific Patient Groups

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?