Study on Gemtuzumab Ozogamicin and Gilteritinib for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation

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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 whose disease has returned or is not responding to treatment. The study is testing a combination of two medications: Gemtuzumab Ozogamicin, known by the brand name Mylotarg, and Gilteritinib, known by the brand name Xospata. Gemtuzumab Ozogamicin is given as an infusion, which means it is administered directly into the bloodstream, while Gilteritinib is taken as a tablet by mouth.

The purpose of the study is to evaluate the safety and effectiveness of this combination treatment in adults with a specific genetic mutation in their leukemia cells called FLT3-ITD. The study is divided into two stages. In the first stage, the focus is on assessing the safety of adding Gilteritinib to the existing treatment plan. In the second stage, the study aims to determine how well the combination works in preventing the cancer from worsening or returning.

Participants in the study will receive the combination treatment and will be monitored for any side effects and how their disease responds to the treatment. The study will also look at how long patients live without the disease getting worse and other outcomes related to their health and quality of life. The trial is expected to continue until 2028, with the goal of providing valuable information on the potential benefits of this treatment combination for patients with relapsed or refractory AML.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age, diagnosis of acute myeloid leukemia (AML), and presence of certain genetic mutations.

The study is designed for adults with relapsed or refractory AML with a specific mutation known as FLT3-ITD.

2 stage 1: safety assessment

The first stage focuses on evaluating the safety of combining two medications: gemtuzumab ozogamicin and gilteritinib.

Gemtuzumab ozogamicin is administered as a solution for infusion, which means it is given intravenously.

Gilteritinib is taken orally in the form of film-coated tablets.

The primary goal is to identify any dose-limiting toxicities, which are side effects that prevent further increase in dosage.

3 stage 2: efficacy assessment

The second stage evaluates the effectiveness of the medication combination in improving event-free survival, which refers to the time during and after treatment that a patient remains free from certain complications or events.

This stage continues to monitor the safety of the treatment.

4 medication administration

Gemtuzumab ozogamicin is given as an infusion, which involves receiving the medication directly into the bloodstream through a vein.

Gilteritinib is taken orally, with the dosage and frequency determined by the study protocol.

5 monitoring and follow-up

Throughout the trial, regular monitoring is conducted to assess the patient’s response to the treatment and to identify any side effects.

This includes routine blood tests and other assessments as required by the study protocol.

6 completion of the trial

The trial is expected to continue until June 2028, with ongoing assessments of safety and efficacy.

Upon completion, the results will contribute to understanding the potential benefits and risks of the treatment combination for patients with relapsed or refractory AML.

Who Can Join the Study?

Patients must be 18 years old or older.
Must have a confirmed diagnosis of R/R AML (a type of leukemia) that is positive for CD33 antigen. This means the leukemia has not responded to treatment or has returned after treatment.
Must have a FLT3-ITD mutation or a FLT3 TKD mutation. These are specific changes in the leukemia cells.
Must not have any medical reasons that prevent them from taking the medications gemtuzumab ozogamicin (GO), cytarabine, and gilteritinib.
Must have an ECOG performance status of 2 or less. This is a scale that measures how well a patient can perform daily activities.
AST and ALT levels must be 2.5 times or less than the normal upper limit, and bilirubin levels must be 1.5 times or less than the normal upper limit, unless these levels are high due to leukemia.
Must have an estimated glomerular filtration rate (GFR) of 50 mL/min or more. This is a measure of how well the kidneys are working.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Acute Myeloid Leukemia cannot participate. Acute Myeloid Leukemia is a type of cancer that affects the blood and bone marrow.
Patients who do not have the specific genetic mutation called FLT3-ITD in their leukemia cells are excluded. This is a change in the DNA that can affect how the leukemia behaves.
Patients who are not between the ages of 3 and 4 years old are excluded.
Patients who are not part of the specific clinical trial group coded as “2” are excluded.
Both male and female patients are eligible, so gender does not exclude participation.
Patients who are considered part of a vulnerable population are not excluded, meaning they can participate if they meet other criteria.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Institut Gustave Roussy	Villejuif	France
Hopital Necker Enfants Malades	Paris	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Antoine Lacassagne	Nice	France
Centre Hospitalier Victor Dupouy	Argenteuil	France
Hôpital Avicenne	Bobigny	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Hopital D’Instruction Des Armees Percy	Clamart	France
Centre Henri Becquerel	Rouen	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Metropole Savoie	Chambery	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Hopital NOVO	Pontoise	France
Centre Hospitalier Universitaire De Nice	Nice	France
Grand Hopital De L Est Francilien	Meaux	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Hôpital Pontchaillou-CHU Rennes	Rennes	France
University Of Bordeaux	Talence	France
Cqbemn Lncu Bjbpxx	Lyon	France
Cjwiel Hugiseqngmq Ej Uiukikzcwodwz Dv Lfkrdkq	Limoges	France
Cgzhwn Hwehhdvrhtv Uoktqrphozkza Dg Ddssg	Dijon	France
Abdkvnonww Pabtlour Hpaygbaa Dn Pcxtb	Paris	France
Alwbglrtmi Pcmrmofx Hfdbstpw Dg Mvvzvaide	Marseille	France
Cuyi Di Njlvn	Vandoeuvre Les Nancy	France
Czjlrv Hrwkobetozr Rkzjjncu Dskqhuctvwoadf	Angers	France
Csbkxg Hnytqgvuvuf Rlqcazzh Uyhmaqrprvwxg Dh Txxyz	Tours	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	03.06.2023

Trial locations

Investigated drugs:

Gemtuzumab Ozogamicin is a medication used in this study to treat a type of blood cancer called acute myeloid leukemia (AML). It works by attaching to cancer cells and delivering a substance that helps kill them. This medication is part of the treatment combination being tested in the trial.

Gilteritinib is another medication used in the study. It is designed to target and block specific proteins that help cancer cells grow, particularly in patients with a mutation known as FLT3-ITD. This medication is being combined with others to see if it improves treatment outcomes for patients with AML.

Cytarabine is a chemotherapy drug included in the treatment combination. It works by interfering with the DNA of cancer cells, preventing them from growing and dividing. This medication is commonly used in the treatment of various types of leukemia, including AML.

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. 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 progresses quickly and requires prompt medical attention. It is more common in adults and can vary in its specific genetic mutations, which can influence the course of the disease. AML is classified into different subtypes based on the characteristics of the leukemia cells.

Trial ID:

2023-504176-25-00

Protocol code:

2020/65

NCT ID:

NCT05199051

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Gemtuzumab Ozogamicin and Gilteritinib for Adults with Relapsed or Refractory Acute Myeloid Leukemia with FLT3 Mutation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?