Study on the Effectiveness of Decitabine and Venetoclax for Patients with Acute Myeloid Leukemia Unfit for Intensive Chemotherapy

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What is this study about?

This clinical trial is focused on studying a treatment for patients with Acute Myeloid Leukemia (AML) that develops from a group of blood disorders known as myeloproliferative neoplasms. These patients are not suitable for intensive chemotherapy. The study is testing a combination of two medications: decitabine and venetoclax. Decitabine is given as a solution through a vein, while venetoclax is taken as a tablet by mouth.

The purpose of the study is to evaluate how effective this combination treatment is in improving the condition of patients with this type of leukemia. Participants will receive the treatment over a period of time, and their health will be monitored to see how well the treatment works and to check for any side effects. The study will also look at how long patients live without the disease getting worse and how the treatment affects their overall survival.

Throughout the study, researchers will collect information on how patients respond to the treatment, including any changes in their blood counts and overall health. The study aims to provide valuable insights into the potential benefits of using decitabine and venetoclax together for treating this specific type of leukemia. Participants will be closely monitored by healthcare professionals to ensure their safety and well-being during the trial.

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.

Eligibility criteria include a diagnosis of acute myeloid leukemia secondary to myeloproliferative neoplasms, being 60 years or older, or being unfit for intensive treatment.

2 treatment initiation

The treatment involves a combination of two medications: decitabine and venetoclax.

Decitabine is administered as an intravenous infusion. The dosage and frequency are determined by the healthcare provider based on individual needs.

Venetoclax is taken orally in the form of film-coated tablets. The dosage may vary, with available strengths of 10 mg, 50 mg, and 100 mg.

3 treatment cycles

The treatment is administered in cycles. Each cycle’s duration and the number of cycles depend on the patient’s response to the treatment.

The primary goal is to achieve event-free survival, which means the absence of disease progression or relapse.

4 monitoring and evaluation

Regular monitoring is conducted to assess the treatment’s effectiveness and any side effects. This includes blood tests and other necessary evaluations.

The response to treatment is evaluated at specific time points after each cycle to determine the overall response rate and disease status.

5 end of treatment

The treatment concludes based on the healthcare provider’s assessment of the patient’s condition and response to the therapy.

Post-treatment 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 type of blood cancer called Acute Myeloid Leukemia (AML) that developed from another condition known as myeloproliferative neoplasms (MPN). This should be newly diagnosed and untreated, based on specific medical criteria.
Patients should be 60 years or older, or adults who are not suitable for intensive treatment, as decided by the doctor.
Patients should have an ECOG performance status of 0 to 2. This is a scale that measures how well a patient can perform daily activities. If the score is 3 due to the disease, it should be reversible with proper care.
Patients must sign a written consent form, agreeing to participate in the study, following international and local laws.
Male patients with partners who can become pregnant must agree to use a reliable method of birth control during the study. They should continue using it for 3 months after the last dose of a drug called decitabine. Female partners should use birth control for 1 month after the last dose of another drug called venetoclax, or 6 months after the last dose of decitabine, whichever is longer.

Who Cannot Join the Study?

Patients who have a different type of cancer that is not related to Acute Myeloid Leukemia (AML) secondary to myeloproliferative neoplasms (MPN). MPN is a group of diseases where the bone marrow makes too many blood cells.
Patients who are fit for intensive chemotherapy. Intensive chemotherapy is a strong treatment that uses drugs to kill cancer cells.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are not considered part of the vulnerable population selected for the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Azienda Ospedaliero Universitaria Careggi	Florence	Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari	Bari	Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli	Naples	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA	Rome	Italy

Other Sites

Site Name	City	Country
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania	Catania	Italy
Azienda Ospedaliero-Universitaria Sant Andre	Rome	Italy
Azienda Ospedaliero Universitaria Di Modena	Modena	Italy
Azienda Sanitaria Universitaria Friuli Centrale	Udine	Italy
Hospital Santa Maria Della Misericordia	Perugia	Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Socio Sanitaria Territoriale Dei Sette Laghi	Varese	Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino	Turin	Italy
Azienda Sanitaria Locale Di Pescara	Pescara	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Istituto Oncologico Veneto	Padua	Italy
Azienda Sanitaria Locale Viterbo	Viterbo	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
ARNAS G. Brotzu	Cagliari	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Universita’ Degli Studi Di Ferrara	Ferrara	Italy
Ajejsuy Srixbbhjc Lwarac Dx Sckmakv	Salerno	Italy
Ayucfal Ooslyvroojj Uyohpwovyhevc Sqghfv	Siena	Italy
Anoircf Ojwqlmrvszx Uccdzlxvjxsvq Cfstlwytgcgl Dffnq Sospcx E Dphqv Shzsqzs Dd Tiuyjb	Turin	Italy
Axpdorv Ohtionufjab Nvrxekboz Sn Amvenjv E Btmkja E C Aaxooh Aaamhpvuyjf	Alexandria	Italy
Aitvqhd Umkvu Sdsupxtim Lurlmm Dd Blljgxi	Bologna	Italy
Agldnhi Ozwhjpygibq Peur Gzgmrmik Xopsp	Bergamo	Italy
Uadgqmlwml Ddkkz Snxtd Dn Rgfw Lz Shjsarhp	Rome	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	03.12.2021

Trial locations

Investigated drugs:

Decitabine is a medication used in this trial to help treat patients with acute myeloid leukemia (AML) that has developed from myeloproliferative neoplasms. It works by interfering with the growth of cancer cells, which may slow down or stop their spread.

Venetoclax is another medication included in the trial. It is designed to help treat AML by targeting and blocking a specific protein that cancer cells need to survive. This can lead to the death of the cancer cells and potentially improve patient outcomes.

Acute Myeloid Leukemia secondary to myeloproliferative neoplasms – This is a type of cancer that starts in the blood-forming cells of the bone marrow and progresses rapidly. It occurs as a secondary condition following myeloproliferative neoplasms, which are disorders characterized by the overproduction of blood cells. In this disease, immature white blood cells, known as myeloblasts, accumulate in the bone marrow and interfere 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. The progression of the disease can vary, but it typically involves a rapid increase in the number of abnormal cells, which can spread to other parts of the body.

Trial ID:

2023-510241-16-00

Protocol code:

AML2420

NCT ID:

NCT04763928

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness of Decitabine and Venetoclax for Patients with Acute Myeloid Leukemia Unfit for Intensive Chemotherapy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?