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ICC APL STUDY 02 Treatment study for children and adolescents with Acute Promyelocytic Leukemia
EU CTIS ID: 2024-518669-83-00
What this study is testing
To assess, in an international pediatric study, the efficacy, in terms of event-free survival, of a combination of ATO and ATRA in newly diagnosed SR APL children and adolescents and to explore the safety and efficacy of a combination therapy comprising ATRA/ATO + GO in HR APL.
- Therapeutic exploratory (Phase II)
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
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age <18 years
- Written informed consent by parents or legal guardians
- If applicable, female participants must have a negative pregnancy test by beta-HCG dosing.
- Patients of child-bearing or child-fathering potential must be willing to adapt their own conduct so as not to procreate during the study participation and must contact their physician to identify the most appropriate approach strategy for this purpose starting from the time of enrolment and for 3 months after receiving the last drug dose
You likely can't join if
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol
- Significant liver dysfunction (bilirubin serum levels >3 mg/dL, ALT/AST serum levels greater than 5 times the normal values)
- Creatinine serum levels >2 times the normal value for age
- Significant arrhythmias, ECG abnormalities (ECG abnormalities: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (<50 beats per minute); QTc >450 msec documented during screening EKG), other cardiac contraindications (L-FEV <50% or LV-FS <28%)
- Neuropathy
- Concurrent active malignancy
See the full eligibility criteria
- Newly diagnosed APL confirmed by the presence of PML/RARα fusion gene
- Age <18 years
- Written informed consent by parents or legal guardians
- If applicable, female participants must have a negative pregnancy test by beta-HCG dosing.
- Patients of child-bearing or child-fathering potential must be willing to adapt their own conduct so as not to procreate during the study participation and must contact their physician to identify the most appropriate approach strategy for this purpose starting from the time of enrolment and for 3 months after receiving the last drug dose
- Patients with a clinical diagnosis of APL but subsequently found to lack PML/RARα rearrangement should be withdrawn from the study and treated on an alternative protocol
- Significant liver dysfunction (bilirubin serum levels >3 mg/dL, ALT/AST serum levels greater than 5 times the normal values)
- Creatinine serum levels >2 times the normal value for age
- Significant arrhythmias, ECG abnormalities (ECG abnormalities: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (<50 beats per minute); QTc >450 msec documented during screening EKG), other cardiac contraindications (L-FEV <50% or LV-FS <28%)
- Neuropathy
- Concurrent active malignancy
- Uncontrolled life-threatening infections
- Pregnant or lactating female
- Patients who had received alternative therapy (APL not initially suspected; ATRA and/or ATO not available)
The study team makes the final eligibility decision.
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. The study team makes the final eligibility decision.
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.