Study of venetoclax with fludarabine, cytarabine and idarubicin combination therapy in newly diagnosed patients with intermediate or high-risk Acute Myeloid Leukemia

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What is this study about?

This study focuses on patients with Acute Myeloid Leukemia, a type of blood cancer that affects bone marrow cells. The research evaluates a treatment combination that includes Venetoclax (taken as tablets) along with three chemotherapy medications: Fludarabine, Cytarabine, and Idarubicin (given through intravenous infusion). This combination is being tested in people who are newly diagnosed with the disease and have an intermediate or high risk of the disease returning.

The purpose of this research is to determine if adding Venetoclax to standard chemotherapy is safe and effective in eliminating the disease from the body. The study will investigate how well patients respond to this combination treatment and monitor any side effects that may occur.

During the study, participants will receive the combination of medications as their initial treatment for Acute Myeloid Leukemia. The treatment involves taking Venetoclax tablets daily along with receiving the other medications through an intravenous line. Doctors will regularly monitor participants’ health status and assess how well the treatment is working through various medical examinations and blood tests.

1 Initial treatment phase

You will receive a combination of medications through different methods:

– Venetoclax tablets taken by mouth (available in 10mg, 50mg, and 100mg doses)

– Fludarabine given through an intravenous (IV) line

– Cytarabine given through an intravenous (IV) line

– Idarubicin given through an intravenous (IV) line

2 Treatment monitoring

Regular checks will be performed to monitor:

– Blood tests to measure liver function

– Kidney function tests

– Physical examinations

– Heart monitoring through ECG tests

– Quality of life assessments

3 Response evaluation

Your response to treatment will be evaluated after the first or second course of therapy

The goal is to achieve complete remission (absence of disease signs)

4 Safety monitoring

Throughout the treatment, you will be monitored for:

– Any side effects from the medications

– Signs of tumor lysis syndrome (a condition that can occur when cancer cells are destroyed quickly)

– Changes in blood test results

This monitoring will continue for up to one year

5 Study completion

The study is expected to continue until July 31, 2025

Your participation duration will depend on your individual treatment plan and response

Who Can Join the Study?

Must be diagnosed with Acute Myeloid Leukemia (a type of blood cancer), newly diagnosed and confirmed by WHO 2017 criteria
Age between 18 and 65 years
Must be physically fit enough to receive chemotherapy, as determined by the doctor
Must have intermediate or high-risk disease according to ELN criteria (European LeukemiaNet risk classification)
Must have good physical functioning status (ECOG Performance Status of 2 or better – able to care for self but unable to work)
Life expectancy must be greater than 12 weeks
Must have adequate liver function, including:
- Normal or slightly elevated bilirubin levels
- Liver enzymes (ALT and AST) within acceptable limits
Must have adequate kidney function (creatinine clearance of 50 ml/min or better)
Must have normal or near-normal pancreas function (lipase and amylase levels)
For women who can become pregnant:
- Must have a negative pregnancy test within 72 hours before starting treatment
- Must use effective birth control during treatment and for 100 days after
For men: Must use effective birth control or be surgically sterile
Must be able to understand and sign informed consent documents
Any previous side effects from treatments must be resolved or mild before starting therapy

Who Cannot Join the Study?

Age below 18 or above 65 years
Patients with low-risk Acute Myeloid Leukemia according to ELN classification (a standardized risk assessment system)
Previous treatment with Venetoclax (a type of cancer medication)
Active or uncontrolled infections
Severe heart conditions or uncontrolled heart disease
Severe liver dysfunction
Severe kidney dysfunction
Known allergy or hypersensitivity to study medications
Pregnant or breastfeeding women
Unable to provide informed consent
Participation in another clinical trial within the last 30 days
Active second cancer requiring treatment
Mental conditions that could interfere with study compliance
History of non-compliance with medical treatments

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
IRCCS Humanitas Research Hospital	Rozzano	Italy
Azienda Ospedaliero Universitaria Di Sassari	Sassari	Italy

Other Sites

Site Name	City	Country
Centro Di Riferimento Oncologico Di Aviano	Aviano	Italy
Azienda Unita Locale Socio Sanitaria N 8 Berica	Vicenza	Italy
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona	Salerno	Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi	Ancona	Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
ASST Grande Ospedale Metropolitano Niguarda	Milan	Italy
Fondazione IRCCS Policlinico San Matteo	Pavia	Italy
IRCCS Ospedale Policlinico San Martino	Genoa	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Universita Degli Studi Di Brescia	Brescia	Italy
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azorzgc Scauobwgy Loqylg Dw Sfyhdct	Salerno	Italy
Iqmnplwv Rkizphglj Pvr Lh Sjsiym Dsa Tmlcwo Dfjl Ahbkpkf Ilaj Sdusfw	Meldola	Italy
Aecmnpv Oysfrfutkmh Uassxgkzarhyw Srxsuo	Siena	Italy
Akkemvy Ovfwsqpoepv Unbvpadxnulyd Ckfgnjcslryj Dqike Seinjt E Dufwn Skwsauh Df Thqstu	Turin	Italy
Acppsuh Occoihafzur Uiombgxwtncno Oygnalwe Rrbvcmn	Foggia	Italy
Abhhwof Uqnqt Swfmqgico Ltfpoi Ds Broihfx	Bologna	Italy
Aggnnrz Oxgxugjrqet Plkh Gekjxlth Xatia	Bergamo	Italy
Umrmuokysn Doycb Smgth Ds Romb Lx Sborsakd	Rome	Italy
Utncnhixzi Mrewb Ghnpxfw Oz Cdpyiergq	Catanzaro	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	26.10.2018

Trial locations

Investigated drugs:

Venetoclax – This medication works by blocking a protein that helps cancer cells survive. In this trial, it is being tested as an add-on treatment for acute myeloid leukemia (AML) in newly diagnosed patients.

Fludarabine – This is a chemotherapy medication that works by interfering with cancer cell DNA, helping to stop cancer cells from growing and dividing.

Cytarabine – This chemotherapy medication works by preventing cancer cells from making and repairing DNA, which helps stop cancer growth and spread.

Idarubicin – This is a type of chemotherapy medication that works by damaging the DNA of cancer cells, preventing them from multiplying. It belongs to a group of drugs called anthracyclines.

These medications are being tested together as a combination therapy for patients who have just been diagnosed with acute myeloid leukemia (excluding the M3 subtype).

Investigated diseases:

Acute myeloid leukaemia

Acute Myeloid Leukemia – A type of blood and bone marrow cancer that affects the production of blood cells. It begins in the bone marrow where blood cells are made, causing rapid growth of abnormal white blood cells that interfere with normal blood cell production. These abnormal cells build up in the bone marrow and blood, leaving less room for healthy blood cells. The disease develops quickly, typically over days or weeks, affecting the body’s ability to fight infections and maintain normal blood functions. As the leukemia cells increase, they can spread to other parts of the body, including the lymph nodes, liver, spleen, central nervous system, and testicles.

Trial ID:

2023-510517-26-00

Protocol code:

AML1718

NCT ID:

NCT03455504

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of venetoclax with fludarabine, cytarabine and idarubicin combination therapy in newly diagnosed patients with intermediate or high-risk Acute Myeloid Leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?