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NOPHO-DBH AML 2012 Protocol: Research study for treatment of children and adolescents with acute myeloid leukemia 0-18 years
EU CTIS ID: 2024-518254-16-00
What this study is testing
The AML 2012 study is a treatment and research protocol with the overall aim of improving prognosis for children and adolescents with AML. This is to be achieved by better risk stratification based on MRD quantification and more intensive induction compared to previous NOPHO protocols. Specific research aims are 1) To investigate if DaunoXome® has a higher efficacy than Mitoxantrone, when given in course 1 for treatment of pediatric AML 2) To investigate if FLADx has a higher efficacy than ADxE when given as the second induction course for treatment of pediatric AML 3) To investigate the correlation between MRD measurement by PCR and flow cytometry and the prognostic impact of MRD with either method after course 1 and 2 respectively.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- AML as defined by the diagnostic criteria in the protocol
- Age below 19 years at time of diagnosis
- Written informed consent
You likely can't join if
- Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy. They can be treated according to the protocol but will not be included in the study population. Secondary AML has a poorer response to chemotherapy but may benefit from SCT if the procedure can be tolerated.
- Positive pregnancy test
- Lactating female or female of childbearing potential not using adequate contraception
- AML secondary to previous bone marrow failure syndrome.
- Down syndrome (DS). Patients with myeloid leukaemia of Down syndrome are recommended to be treated according to the international ML-DS protocol. Patients with AML and DS older than 5 years who often lack GATA1 mutation and do not have typical myeloid leukaemia of DS may be treated according to the protocol but will not be included in the study population.
- Acute promyelocytic leukaemia (APL). These patients are recommended treatment according to the international APL Study.
See the full eligibility criteria
- AML as defined by the diagnostic criteria in the protocol
- Age below 19 years at time of diagnosis
- Written informed consent
- Previous chemotherapy or radiotherapy. This includes patient with secondary AML after previous cancer therapy. They can be treated according to the protocol but will not be included in the study population. Secondary AML has a poorer response to chemotherapy but may benefit from SCT if the procedure can be tolerated.
- Positive pregnancy test
- Lactating female or female of childbearing potential not using adequate contraception
- AML secondary to previous bone marrow failure syndrome.
- Down syndrome (DS). Patients with myeloid leukaemia of Down syndrome are recommended to be treated according to the international ML-DS protocol. Patients with AML and DS older than 5 years who often lack GATA1 mutation and do not have typical myeloid leukaemia of DS may be treated according to the protocol but will not be included in the study population.
- Acute promyelocytic leukaemia (APL). These patients are recommended treatment according to the international APL Study.
- Myelodysplastic syndrome (MDS). These patients are recommended treatment according to EWOG-MDS.
- Juvenile Myelomonocytic Leukaemia (JMML). These patients are recommended treatment according to EWOG-MDS.
- Known intolerance to any of the chemotherapeutic drugs in the protocol.
- Fanconi anemia
- Major organ failure precluding administration of planned therapy
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.