Study on Treating Acute Myeloid Leukemia in Children and Adolescents Using Daunorubicin, Mitoxantrone, and a Drug Combination

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What is this study about?

This clinical trial is focused on studying the treatment of Acute Myeloid Leukemia (AML) in children and adolescents aged 0 to 18 years. AML is a type of cancer that affects the blood and bone marrow, where blood cells are made. The study aims to improve the outcomes for young patients with AML by using a combination of different medications and treatment strategies.

The medications being tested in this study include DaunoXome®, Mitoxantrone, Fludarabine Phosphate, Daunorubicin, Daunorubicin Hydrochloride, Cytarabine, and Etoposide. These drugs are administered intravenously, meaning they are given directly into a vein. The study will compare the effectiveness of these medications in treating AML, with the goal of finding the best treatment approach. The trial will also explore how well the disease responds to treatment by measuring the levels of cancer cells remaining in the body after treatment, known as Minimal Residual Disease (MRD).

Participants in the study will receive treatment over a period of several months, with regular monitoring to assess how well the treatment is working. The study will also look at the long-term effects of the treatment, including survival rates and any potential side effects. The ultimate goal is to improve the prognosis for children and adolescents with AML by using more effective treatment strategies.

1 joining the study

Participation begins after meeting the criteria: diagnosis of acute myeloid leukemia (AML), age below 19 years, and providing written consent.

2 first induction course

The first treatment involves the administration of DaunoXome® or Mitoxantrone through an intravenous route. The goal is to determine which medication is more effective in treating pediatric AML.

The effectiveness is measured by the level of minimal residual disease (MRD) using flow cytometry. The target is to achieve an MRD level below 0.1%.

3 second induction course

The second treatment involves the administration of FLADx or ADxE through an intravenous route. This step aims to evaluate the efficacy of these medications in further reducing AML.

MRD levels are again measured to assess the treatment’s success, with the same target of achieving an MRD level below 0.1%.

4 monitoring and follow-up

Throughout the trial, regular monitoring of cardiac function and other health parameters is conducted to ensure safety and effectiveness.

The study also tracks event-free survival and overall survival over a period of five years, along with the frequency of any severe adverse events.

Who Can Join the Study?

The patient must have Acute Myeloid Leukemia (AML), which is a type of blood cancer, as defined by the study’s diagnostic criteria.
The patient must be younger than 19 years old at the time of diagnosis.
The patient or their guardian must provide written informed consent, which means they agree to participate in the study after being fully informed about it.

Who Cannot Join the Study?

Patients who do not have Acute Myeloid Leukemia (AML), which is a type of blood cancer, cannot participate.
Patients who are not within the age range of 0-18 years cannot participate.
Patients who are not children or adolescents cannot participate.
Patients who are not able to undergo the specific treatments being studied cannot participate.
Patients who are not able to follow the study procedures cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Oslo Universitetssykehus HF	Oslo	Norway
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Universitetssykehuset Nord-Norge HF	Tromsø	Norway
Hospital Infantil Universitario Nino Jesus	Madrid	Spain
Region Oestergoetland	Linkoping	Sweden
Region Vaesterbotten	Umea	Sweden
Universitair Ziekenhuis Gent	Gent	Belgium
Hospital Sant Joan De Deu Barcelona	Esplugues De Llobregat	Spain
Centre Hospitalier Regional De La Citadelle	Liege	Belgium
Hospital General Universitario Gregorio Maranon	Madrid	Spain
St. Olavs Hospital HF	Trondheim	Norway
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Complejo Hospitalario Universitario Insular Materno Infantil	Las Palmas De Gran Canaria	Spain
Pohjois-Pohjanmaan hyvinvointialue	Oulu	Finland
Hospital General Universitario De Alicante	Alicante	Spain
Hospital Clinico Universitario De Valencia	Valencia	Spain
Hospital Unviersitario Miguel Servet	Zaragoza	Spain
Virgen del Rocío University Hospital	Sevilla	Spain
Region Skane Skanes Universitetssjukhus	Lund	Sweden
Karolinska University Hospital	Solna	Sweden
Hospital Universitario De Cruces	Barakaldo	Spain
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain
Universidade De Santiago De Compostela	Santiago De Compostela	Spain
Prinses Maxima Centrum voor Kinderoncologie B.V.	Utrecht	The Netherlands
CHC MontLegia	Liege	Belgium
Region Midtjylland	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Pohjois-Savon hyvinvointialue	Kuopio	Finland
Pirkanmaan hyvinvointialue	Tampere	Finland
University Childrens Hospital Queen Fabiola	Brussels	Belgium
Servei De Salut De Les Illes Balears	Palma	Spain
Csjkbxovo Udynndleydxssg Suylbapwt	Woluwe-Saint-Lambert	Belgium
Vadamepgixgamlnx hxtkklpqnjgrvcs	Turku	Finland
Hqgayxyf Uebywnaogrgtj Rjywgrix Dv Mhvhzx	Malaga	Spain
Ufcufgt Uajuxdctsk Heuqjcsu	Uppsala	Sweden
Hqbmq Blkkuz Hz	Bergen	Norway
Hdzghrnh Ufcrwnirqa Cpfiaps Hmujvtup	Helsinki	Finland
Howlmeku Dk La Swdiy Cxaa I Safb Pzv	Barcelona	Spain
Fnmaatvst Pfan Lg Ifoeyeuzhxhxc Bjzjmenuv Ddj Hnwsqneg Usvopdyjtrgno Lw Pkw	Madrid	Spain
Hnrpylqy Vmiq ddfdxwwx	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	08.03.2013
Denmark	Recruiting	08.03.2013
Finland	Recruiting	08.03.2013
Norway	Recruiting	08.03.2013
Spain	Recruiting	08.03.2013
Sweden	Recruiting	08.03.2013
The Netherlands	Recruiting	08.03.2013

Trial locations

Investigated drugs:

DaunoXome is a medication being studied to see if it is more effective than another drug, Mitoxantrone, in treating children and adolescents with acute myeloid leukemia (AML) during the first course of treatment. It is used to help kill cancer cells and improve the chances of recovery.

Mitoxantrone is a medication used in the study as a comparison to DaunoXome. It is also used in the first course of treatment for pediatric AML to help destroy cancer cells and improve patient outcomes.

FLADx is a combination of medications used in the study to see if it works better than another combination called ADxE during the second course of treatment for pediatric AML. This combination aims to further reduce the number of cancer cells and improve the effectiveness of the treatment.

ADxE is another combination of medications used in the study as a comparison to FLADx. It is given during the second course of treatment for pediatric AML to help eliminate cancer cells and improve the prognosis for patients.

Acute Myeloid Leukemia (Pediatric 0-18 years) – Acute Myeloid Leukemia (AML) in children is a type of cancer that affects the blood and bone marrow. It is characterized by the rapid growth of abnormal white blood cells that accumulate in the bone marrow and interfere with the production of normal blood cells. Symptoms may include fatigue, fever, easy bruising or bleeding, and an increased risk of infections. The disease progresses quickly and requires prompt medical attention. AML in children can vary in its presentation and severity, and it often requires intensive treatment to manage. The condition is studied to improve understanding and treatment strategies, focusing on risk stratification and response to therapy.

Trial ID:

2024-518254-16-00

NCT ID:

NCT01828489

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Treating Acute Myeloid Leukemia in Children and Adolescents Using Daunorubicin, Mitoxantrone, and a Drug Combination

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?