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Study on Early Treatment Intensification for Acute Myeloid Leukemia with FLT3 Mutation Using Cytarabine, Midostaurin, and Daunorubicin Hydrochloride for Patients with Low Chemosensitivity

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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), specifically in patients who have a genetic change known as the FLT3 mutation. The study aims to find the best treatment approach for these patients by using a special marker called peripheral blast clearance (PBC) to tailor the therapy. The trial will compare different treatment plans to see which one helps patients live longer without the disease coming back.

The treatments being tested in this study include several medications. One of the main drugs is cytarabine, which is given as an injection. Another medication used is midostaurin, which comes in the form of a soft capsule taken by mouth. Additionally, daunorubicin hydrochloride is used, which is a powder that is mixed and given through an infusion into a vein. Some patients may also receive a placebo, which looks like the real medication but does not contain any active ingredients.

During the study, participants will receive these treatments over a period of time, with the goal of improving their chances of recovery. The study will monitor how well the treatments work and how safe they are for the patients. By using the PBC marker, the study hopes to identify which treatment plan is most effective for patients with the FLT3 mutation in AML. The results of this study could help doctors better understand how to treat this type of leukemia in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of a FLT3 mutation in acute myeloid leukemia (AML) and ensuring all necessary diagnostic materials are available.

The assessment also checks for identifiable leukemia cells in the blood and evaluates the immune system’s response to the disease.

2 treatment induction

The treatment begins with an induction phase. During this phase, you will receive high doses of medications to reduce leukemia cells.

The medications include cytarabine administered intravenously, midostaurin taken orally, and daunorubicin hydrochloride given through intravenous infusion.

3 peripheral blast clearance measurement

On day 4 of the treatment, a measurement of peripheral blast clearance (PBC) is conducted. This test helps determine how well the treatment is working by measuring the reduction of leukemia cells in the blood.

4 treatment intensification

Based on the PBC results, the treatment may be intensified. This involves adjusting the medication doses or adding new treatments to improve outcomes.

The goal is to enhance the effectiveness of the treatment for those with low PBC results.

5 consolidation phase

Following the induction phase, a consolidation phase occurs. This phase aims to eliminate any remaining leukemia cells and prevent relapse.

During this phase, you may be considered for an allogeneic transplant, which involves receiving healthy stem cells from a donor.

6 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess your response to treatment and manage any side effects.

Follow-up visits are scheduled to evaluate your health status and ensure the treatment’s long-term effectiveness.

Who Can Join the Study?

  • Patients must have a type of blood cancer called Acute Myeloid Leukemia (AML) that has a specific change in the FLT3 gene.
  • The AML must be newly diagnosed and not previously treated.
  • There must be enough biological material available for detailed testing of the disease.
  • There must be visible cancer cells, called blasts, in the blood at the time of diagnosis.
  • The cancer must show a specific pattern, called Leukemia-associated aberrant immune-phenotype (LAIP), which is checked using a test called multiparametric flow cytometry (MFC).
  • Patients must be between 18 and 65 years old.
  • Patients must have a general health status that is measured by a scale called ECOG performance status, which should be between 0 and 2, or 3 if it can be improved with care.
  • Patients must sign a written consent form agreeing to participate in the study, following international and local laws.

Who Cannot Join the Study?

  • Patients who do not have Acute Myeloid Leukemia (AML) with a FLT3 mutation cannot participate. Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow. FLT3 mutation is a specific change in the DNA of the leukemia cells.
  • Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
  • Patients who are not predicted to have low chemosensitivity cannot participate. Chemosensitivity refers to how well cancer cells respond to chemotherapy.
  • Patients who are not able to undergo the required treatment intensification phases, such as high-dose delivery or allogeneic transplant, cannot participate. Allogeneic transplant is a procedure where a patient receives blood-forming stem cells from a donor.
  • Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of patients.
  • Patients who are not male or female cannot participate, as the study includes both genders.
  • Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or those with certain disabilities.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy
Azienda Ospedaliero Universitaria Di Sassari Sassari Italy
Ospedale dell’Angelo di Mestre Mestre – Venezia Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy

Other Sites

Site Name City Country Status
Istituto Oncologico Veneto Padua Italy
Ospedale Vito Fazzi Lecce Lecce Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Azienda Unita Sanitaria Locale Di Piacenza Piacenza Italy
Hospital Santa Maria Della Misericordia Perugia Italy
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
Istituto Tumori Bari Giovanni Paolo II Bari Italy
Azienda Ospedaliera Ordine Mauriziano Di Torino Turin Italy
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d’Aragona Salerno Italy
Azienda Sanitaria Locale Di Pescara Pescara Italy
Grande Ospedale Metropolitano Bianchi Melacrino Morelli Reggio Calabria Italy
Ospedale Santa Maria Goretti Latina Latina Italy
Azienda Ospedaliera di Padova Padua Italy
Azienda Sanitaria Locale Viterbo Viterbo Italy
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
Fondazione IRCCS Policlinico San Matteo Pavia Italy
Universita’ Campus Bio-medico Di Roma Rome Italy
Azienda Ospedaliero-Universitaria Maggiore Della Carita Novara Italy
Azienda Unita Sanitaria Locale Della Romagna Faenza Italy
Universita Degli Studi Di Brescia Brescia Italy
Universita’ Degli Studi Di Ferrara Ferrara Italy
IRCCS CROB Rionero In Vulture Italy
University Hospital Consorziale Policlinico Bari Italy
Azienda Sanitaria Locale Di Salerno Battipaglia Italy
Aavjcna Oidjbnaluof Ocudytdn Rzlwmte Vqopz Siwtw Cxuquxas Palermo Italy
Avwwwru Osunaosnimm Uqvluuukcwspu Sxdfsg Siena Italy
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Axfyxnz Ohvawhaibpw Nmjqkphdf Sr Aoaayus E Bnoyje E C Arwccf Acvxshoyatb Alexandria Italy
Aafxdor Ufh Iqqjz Du Rrzfmw Exrcos Reggio Emilia Italy
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Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Recruiting
24.04.2020

Trial locations

Investigated drugs:

FLT3 Inhibitor is a type of medication used in this trial to target a specific mutation found in some acute myeloid leukemia (AML) patients. This medication works by blocking the activity of the FLT3 protein, which is often overactive in these patients. By inhibiting this protein, the medication aims to slow down or stop the growth of cancer cells, helping to improve the patient’s condition.

High-dose Chemotherapy is a treatment approach used in the trial to aggressively target and kill cancer cells. This therapy involves using higher doses of chemotherapy drugs than usual to increase the chances of eliminating cancer cells from the body. The goal is to reduce the number of cancer cells significantly, which can help in achieving remission in patients with AML.

Allogeneic Transplant is a procedure included in the trial as part of the consolidation phase of treatment. This therapy involves replacing the patient’s diseased bone marrow with healthy bone marrow from a donor. The new bone marrow can produce healthy blood cells, which can help restore the patient’s immune system and improve their chances of recovery from AML.

Investigated diseases:

Acute Myeloid Leukemia with FLT3 Mutation – 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. The FLT3 mutation is a genetic alteration found in some AML patients, which can lead to more aggressive disease progression. In AML with FLT3 mutation, the abnormal cells accumulate in the bone marrow, interfering with the production of normal blood cells. This can result in symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses as these abnormal cells continue to multiply and spread, potentially affecting other organs. The presence of the FLT3 mutation often indicates a higher risk of rapid disease progression.

Trial ID:
2023-505901-17-00
Protocol code:
GIMEMA AML1919
NCT ID:
NCT04174612
Trial Phase:
Therapeutic confirmatory (Phase III)

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